In this study involving patients with new-onset postoperative atrial fibrillation who received either rate control or rhythm control, there was no significant difference in rates of hospitalization, ...complications, or persistent atrial fibrillation 60 days after onset.
In recent years, much research has focused on the prevention of atrial fibrillation after cardiac surgery, but highly effective interventions are lacking. Thus, postoperative atrial fibrillation remains the most common complication after cardiac surgery, with an incidence of 20 to 50%.
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This complication has major adverse consequences for patients and the health care system, including increased rates of death, complications, and hospitalizations and inflated costs.
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Therefore, efforts to determine the most effective preventive strategies and management practices are important. There are two general approaches to managing postoperative atrial fibrillation: heart-rate control (hereafter “rate control”) and rhythm control with . . .
This clinical trial compared mitral-valve repair with replacement for severe ischemic mitral regurgitation. There were no significant between-group differences in left ventricular remodeling and ...clinical outcomes, but replacement was associated with more durable correction.
Functional ischemic mitral regurgitation affects 1.6 million to 2.8 million patients in the United States and is associated with a doubling in mortality among patients with mild or greater degrees of mitral regurgitation after myocardial infarction.
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Ischemic mitral regurgitation is a consequence of adverse left ventricular remodeling after myocardial injury with enlargement of the left ventricular chamber and mitral annulus, apical and lateral migration of the papillary muscles, leaflet tethering, and reduced closing forces. These processes lead to malcoaptation of the leaflets and variable degrees of mitral regurgitation that can fluctuate dynamically as a function of volume status, afterload, . . .
There are limited therapeutic options for patients with coronavirus disease (COVID-19)-related acute respiratory distress syndrome with inflammation-mediated lung injury. Mesenchymal stromal cells ...offer promise as immunomodulatory agents.
Evaluation of efficacy and safety of allogeneic mesenchymal cells in mechanically-ventilated patients with moderate or severe COVID-19-induced respiratory failure.
Patients were randomized to two infusions of 2 million cells/kg or sham infusions, in addition to the standard of care. We hypothesized that cell therapy would be superior to sham control for the primary endpoint of 30-day mortality. The key secondary endpoint was ventilator-free survival within 60 days, accounting for deaths and withdrawals in a ranked analysis.
At the third interim analysis, the data and safety monitoring board recommended that the trial halt enrollment as the prespecified mortality reduction from 40% to 23% was unlikely to be achieved (
= 222 out of planned 300). Thirty-day mortality was 37.5% (42/112) in cell recipients versus 42.7% (47/110) in control patients (relative risk RR, 0.88; 95% confidence interval, 0.64-1.21;
= 0.43). There were no significant differences in days alive off ventilation within 60 days (median rank, 117.3 interquartile range, 60.0-169.5 in cell patients and 102.0 interquartile range, 54.0-162.5 in control subjects; higher is better). Resolution or improvement of acute respiratory distress syndrome at 30 days was observed in 51/104 (49.0%) cell recipients and 46/106 (43.4%) control patients (odds ratio, 1.36; 95% confidence interval, 0.57-3.21). There were no infusion-related toxicities and overall serious adverse events over 30 days were similar.
Mesenchymal cells, while safe, did not improve 30-day survival or 60-day ventilator-free days in patients with moderate and/or severe COVID-19-related acute respiratory distress syndrome.
Diffuse intimal hyperplasia and graft irregularity adversely affect the long-term patency of saphenous vein grafts (SVGs) and clinical outcomes of patients undergoing coronary artery bypass grafting ...(CABG). The VEST trial evaluated the efficacy of external graft support in limiting the development of intimal hyperplasia (IH) at 1 year postsurgery. In the present secondary analysis, we explored the associations between graft disease and IH and clinical events. We also examined risk factors for early graft occlusion.
VEST is a within-patient randomized, multicenter trial that enrolled 224 patients with multivessel coronary disease undergoing CABG surgery, of whom 203 were evaluated by 1 year postsurgery. Intimal hyperplasia, lumen uniformity, graft stenosis, and graft perfusion were measured by intravascular ultrasound and angiography. Major cardiac and cerebrovascular events (MACCE; including death, myocardial infarction, stroke, and revascularization) were recorded over a median follow-up of 3 years.
Worse lumen uniformity, greater stenosis, and worse graft perfusion were associated with higher IH values and an increased incidence of clinical events. Consistent with previous findings, we identified endoscopic vein harvesting, female sex, and transit time flow measurement of pulsatility index and flow as risk factors for SVG occlusion during the first year postsurgery.
In this secondary analysis of the VEST trial, we observed an association between intimal hyperplasia area and clinical measures of SVG disease at 1 year postsurgery. More severe SVG disease and larger areas of IH were associated with a higher incidence of 3-year MACCE. Ongoing follow-up to 5 years will further elucidate the impact of SVG disease on long-term clinical outcomes of CABG.
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Abstract Background Infections are the most common noncardiac complication after cardiac surgery, but their incidence across a broad range of operations, as well as the management factors that shape ...infection risk, remain unknown. Objectives This study sought to prospectively examine the frequency of post-operative infections and associated mortality, and modifiable management practices predictive of infections within 65 days from cardiac surgery. Methods This study enrolled 5,158 patients and analyzed independently adjudicated infections using a competing risk model (with death as the competing event). Results Nearly 5% of patients experienced major infections. Baseline characteristics associated with increased infection risk included chronic lung disease (hazard ratio HR: 1.66; 95% confidence interval CI: 1.21 to 2.26), heart failure (HR: 1.47; 95% CI: 1.11 to 1.95), and longer surgery (HR: 1.31; 95% CI: 1.21 to 1.41). Practices associated with reduced infection risk included prophylaxis with second-generation cephalosporins (HR: 0.70; 95% CI: 0.52 to 0.94), whereas post-operative antibiotic duration >48 h (HR: 1.92; 95% CI: 1.28 to 2.88), stress hyperglycemia (HR: 1.32; 95% CI: 1.01 to 1.73); intubation time of 24 to 48 h (HR: 1.49; 95% CI: 1.04 to 2.14); and ventilation >48 h (HR: 2.45; 95% CI: 1.66 to 3.63) were associated with increased risk. HRs for infection were similar with either <24 h or <48 h of antibiotic prophylaxis. There was a significant but differential effect of transfusion by surgery type (excluding left ventricular assist device procedures/transplant) (HR: 1.13; 95% CI: 1.07 to 1.20). Major infections substantially increased mortality (HR: 10.02; 95% CI: 6.12 to 16.39). Conclusions Major infections dramatically affect survival and readmissions. Second-generation cephalosporins were strongly associated with reduced major infection risk, but optimal duration of antibiotic prophylaxis requires further study. Given practice variations, considerable opportunities exist for improving outcomes and preventing readmissions. (Management Practices and Risk of Infection Following Cardiac Surgery; NCT01089712 )
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
After 2 years of follow-up in a randomized trial involving 301 patients with moderate ischemic mitral regurgitation undergoing CABG, the addition of mitral-valve repair did not improve left ...ventricular function or remodeling.
Ischemic mitral regurgitation of moderate severity develops in approximately 10% of patients after myocardial infarction.
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Mitral regurgitation is caused by the displacement of papillary muscle, leaflet tethering, reduced closing forces, and annular dilatation. Over time, the condition has an adverse effect on the rate of survival free of heart failure.
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Because most patients with ischemic mitral regurgitation have multivessel coronary artery disease requiring revascularization, surgeons have to consider whether to add mitral-valve repair to coronary-artery bypass grafting (CABG).
The appropriate surgical management of moderate ischemic mitral regurgitation at the time of CABG remains controversial. Some experts advocate revascularization alone . . .
In a recent trial, tricuspid annuloplasty (TA) during mitral valve surgery (MVS) for degenerative mitral regurgitation and moderate or less tricuspid regurgitation (TR) reduced the composite rate of ...death, reoperation for TR, or TR progression at 2 years. However, this benefit was counterbalanced by an increase in implantation of permanent pacemakers (PPMs). In this study, we analyzed the timing, indications, and risk factors for these implantations.
We randomized 401 patients (MVS alone = 203; MVS + TA = 198). Potential risk factors for PPMs were assessed using multivariable time-to-event models with death and PPM implantation for heart failure indications as competing risks.
A PPM was implanted in 36 patients (9.6; 95% CI, 6.8-13.0) within 2 years of randomization, with 30/187 (16.0%) in the MVS + TA and 6/188 (3.2%) in the MVS groups (rate ratio, 5.08; 95% CI, 2.16-11.94; P < .001). Most (29/36; 80.6%) implantations occurred within 30 days postoperatively. Independent risk factors for PPM implantation within 2 years were TA (hazard ratio HR, 5.94; 95% CI, 2.27-15.53; P < .001), increasing age (5 years, HR, 1.23; 95% CI, 1.01-1.52; P = .04), and left ventricular ejection fraction (LVEF; HR, 0.96; 95% CI, 0.92-0.99; P = .02). In the subset of TA recipients (n = 197), age (5 years, HR, 1.05; 95% CI, 1.00-1.10; P = .04) and LVEF (HR, 0.95; 95% CI, 0.91-0.99; P = .01) were associated with PPM within 2 years.
Concomitant TA, age, and baseline LVEF were risk factors for PPM implantation in patients who underwent MVS for degenerative mitral regurgitation. Although TA was effective in preventing progression of TR, innovation is needed to identify ways to decrease PPM implantation rates.
This trial compared coronary-artery bypass grafting alone with CABG plus mitral-valve repair in patients with coronary artery disease and moderate ischemic mitral regurgitation. Mitral-valve repair ...provided no apparent benefit and was associated with more neurologic complications.
Each year, approximately 1 million Americans have a myocardial infarction, and nearly 8 million Americans have a history of myocardial infarction.
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Ischemic mitral regurgitation, which results from functional-valve incompetence due to myocardial injury and adverse left ventricular remodeling, develops in approximately 50% of patients after an infarction, and moderate regurgitation occurs in more than 10% of patients.
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Ischemic mitral regurgitation is associated with excess mortality regardless of management.
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The valve leaflets and chordal structures in affected patients are “innocent bystanders”; mitral regurgitation results from papillary muscle displacement, leaflet tethering, reduced closing forces, and annular dilatation.
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Many patients . . .
In a randomized trial involving patients undergoing mitral-valve surgery for degenerative mitral regurgitation, the addition of tricuspid repair resulted in a lower risk of the primary outcome, a ...composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation, or death. Tricuspid repair resulted in more frequent permanent pacemaker implantation.
IMPORTANCE: Left ventricular assist device (LVAD) therapy improves myocardial function, but few patients recover sufficiently for explant, which has focused attention on stem cells to augment cardiac ...recovery. OBJECTIVE: To assess efficacy and adverse effects of intramyocardial injections of mesenchymal precursor cells (MPCs) during LVAD implant. DESIGN, SETTING, AND PARTICIPANTS: A randomized phase 2 clinical trial involving patients with advanced heart failure, undergoing LVAD implant, at 19 North American centers (July 2015-August 2017). The 1-year follow-up ended August 2018. INTERVENTIONS: Intramyocardial injections of 150 million allogeneic MPCs or cryoprotective medium as a sham treatment in a 2:1 ratio (n = 106 vs n = 53). MAIN OUTCOMES AND MEASURES: The primary efficacy end point was the proportion of successful temporary weans (of 3 planned assessments) from LVAD support within 6 months of randomization. This end point was assessed using a Bayesian analysis with a predefined threshold of a posterior probability of 80% to indicate success. The 1-year primary safety end point was the incidence of intervention-related adverse events (myocarditis, myocardial rupture, neoplasm, hypersensitivity reactions, and immune sensitization). Secondary end points included readmissions and adverse events at 6 months and 1-year survival. RESULTS: Of 159 patients (mean age, 56 years; 11.3% women), 155 (97.5%) completed 1-year of follow-up. The posterior probability that MPCs increased the likelihood of successful weaning was 69%; below the predefined threshold for success. The mean proportion of successful temporary weaning from LVAD support over 6 months was 61% in the MPC group and 58% in the control group (rate ratio RR, 1.08; 95% CI, 0.83-1.41; P = .55). No patient experienced a primary safety end point. Of 10 prespecified secondary end points reported, 9 did not reach statistical significance. One-year mortality was not significantly different between the MPC group and the control group (14.2% vs 15.1%; hazard ratio HR, 0.89; 95%, CI, 0.38-2.11; P = .80). The rate of serious adverse events was not significantly different between groups (70.9 vs 78.7 per 100 patient-months; difference, −7.89; 95% CI, −39.95 to 24.17; P = .63) nor was the rate of readmissions (0.68 vs 0.75 per 100 patient-days; difference, −0.07; 95% CI, −0.41 to 0.27; P = .68). CONCLUSIONS AND RELEVANCE: Among patients with advanced heart failure, intramyocardial injections of mesenchymal precursor cells, compared with injections of a cryoprotective medium as sham treatment, did not improve successful temporary weaning from left ventricular assist device support at 6 months. The findings do not support the use of intramyocardial mesenchymal stem cells to promote cardiac recovery as measured by temporary weaning from device support. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02362646
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