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Long-Term Results of Early Surgery versus Conventional Treatment for Infective Endocarditis Trial.

ABSTRACT: BACKGROUND AND OBJECTIVES:Compared with conventional treatment, early surgery significantly reduced the composite end point of all-cause death and embolic events during hospitalization, but long-term data in this area are lacking. This study sought to compare long-term outcomes of early surgery with a conventional treatment strategy in patients with infective endocarditis (IE) and large vegetations. SUBJECTS AND METHODS:The Early Surgery versus Conventional Treatment in Infective Endocarditis (EASE) trial randomly assigned patients with left-sided IE, severe valve disease and large vegetation to early surgery (37 patients) or conventional treatment groups (39 patients). The pre-specified end points were all-cause death, embolic events, recurrence of IE and repeat hospitalizations due to the development of congestive heart failure occurring during follow-up. RESULTS:There were no significant differences between the early surgery and the conventional treatment group in all-cause mortality at 4 years (8.1% and 7.7%, respectively; hazard ratio [HR] 1.04; 95% CI, 0.21 to 5.15; p=0.96). The rate of the composite end point of death from any cause, embolic events or recurrence of IE at 4 years was 8.1% in the early surgery group and 30.8% in the conventional treatment group (HR, 0.22; 95% CI, 0.06-0.78; p=0.02). The estimated actuarial rate of end points at 7 years was significantly lower in the early surgery group than in the conventional treatment group (log-rank p=0.007). CONCLUSION:There was a substantial benefit in having early surgery for patients with IE and large vegetations whose health was sustained up to 7 years, and late clinical outcome after surgery was excellent in survivors of IE. (EASE clinicaltrials.gov identifier: NCT00750373).

SUBMITTER: Kang DH

PROVIDER: S-EPMC5099342 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Long-Term Results of Early Surgery versus Conventional Treatment for Infective Endocarditis Trial.

Kang Duk-Hyun DH Lee Sahmin S Kim Yong-Jin YJ Kim Sung-Han SH Kim Dae-Hee DH Yun Sung-Cheol SC Song Jong-Min JM Chung Cheol-Hyun CH Song Jae-Kwan JK Lee Jae-Won JW

Korean circulation journal 20161020 6

<h4>Background and objectives</h4>Compared with conventional treatment, early surgery significantly reduced the composite end point of all-cause death and embolic events during hospitalization, but long-term data in this area are lacking. This study sought to compare long-term outcomes of early surgery with a conventional treatment strategy in patients with infective endocarditis (IE) and large vegetations.<h4>Subjects and methods</h4>The Early Surgery versus Conventional Treatment in Infective ...[more]

PMID: 27826345

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Project description:To systematically review early surgery and the optimal timing of surgery in patients with infective endocarditis (IE), a search for foreign and domestic articles on cohort studies about the association between early surgery and infective endocarditis published from inception to January 2015 was conducted in the PubMed, EMBASE, Chinese Biomedical Literature (CBM), Wanfang and Chinese National Knowledge Infrastructure (CNKI) databases. The studies were screened according to the inclusion and exclusion criteria, the data were extracted and the quality of the method of the included studies was assessed. Then, the meta-analysis was performed using the Stata 12.0 software. Sixteen cohort studies, including 8141 participants were finally included. The results of the meta-analysis revealed that, compared with non-early surgery, early surgery in IE lowers the incidence of in-hospital mortality [odds ratio (OR) = 0.57, 95% confidence interval (CI) (0.42, 0.77); P = 0.000, I(2) = 73.1%] and long-term mortality [OR = 0.57, 95% CI (0.43, 0.77); P = 0.001, I(2) = 67.4%]. Further, performing operation within 2 weeks had a more favourable effect on long-term mortality [OR = 0.63, 95% CI (0.41, 0.97); P = 0.192, I(2) = 39.4%] than non-early surgery. In different kinds of IE, we found that early surgery for native valve endocarditis (NVE) had a lower in-hospital [OR = 0.46, 95% CI (0.31, 0.69); P = 0.001, I(2) = 73.0%] and long-term [OR = 0.57, 95% CI (0.40, 0.81); P = 0.001, I(2) = 68.9%] mortality than the non-early surgery group. However, for prosthetic valve endocarditis (PVE), in-hospital mortality did not differ significantly [OR = 0.83, 95% CI (0.65, 1.06); P = 0.413, I(2) = 0.0%] between early and non-early surgery. We concluded that early surgery was associated with lower in-hospital and long-term mortality compared with non-early surgical treatment for IE, especially in NVE. However, the optimal timing of surgery remains unclear. Additional larger prospective clinical trials will be required to clarify the optimal timing for surgical intervention and determine its efficacy in PVE.

Project description:BackgroundDespite novel improvements in the diagnosis and treatment of infective endocarditis (IE), there has been no significant improvement in the survival rate of IE, which indicates that many details still need to be optimized in the preoperative assessment. We sought to evaluate preoperative serum albumin as a biomarker for predicting early mortality after IE surgery.MethodsBetween October 2013 and June 2019, patients with a definite diagnosis of IE were enrolled in this study. Patients' albumin levels at admission were used as the preoperative albumin levels. Restricted cubic spline and multivariate logistic regression analyses were performed to evaluate the relationship between albumin and early mortality. Receiver operating characteristic curve analyses were performed to assess the role of albumin in predicting early mortality and compare the predictive capacity of traditional models with models that included albumin.ResultsOf the 276 IE patients, 20 (7.2%) died in hospital or within 30 days of surgery. Hypoalbuminemia (an albumin level <3.5 g/dL) was present in 109 (39.5%) patients. The multivariate logistic regression analysis showed that preoperative albumin was inversely associated with early mortality [adjusted odds ratio (OR) =0.22 per 1 g/dL, 95% confidence interval (CI): 0.07-0.65, P=0.006] after full adjustment. Preoperative albumin had value in predicting early mortality [area under the curve (AUC) =0.72, 95% CI: 0.61-0.84; P<0.01]. After adding albumin to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) and Charlson score, the predictive ability of the model was further improved (EuroSCORE II: AUC =0.55; 95% CI: 0.42-0.67 to AUC =0.72; 95% CI: 0.61-0.84; Charlson score: AUC =0.73; 95% CI: 0.64-0.83 to AUC =0.78; 95% CI: 0.68-0.88).ConclusionsPreoperative serum albumin is inversely associated with early mortality after IE surgery, and is a promising prognostic indicator in preoperative risk stratification assessments of IE patients.

Project description:Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalisation, high-dosage antibiotic therapy and possible valve replacement surgery. Despite advances in treatment, the 1-year mortality remains at 20-40%. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work up to a year postdischarge. No studies investigating the effects of rehabilitation have been published. We present the rationale and design of the CopenHeart(IE) trial, which investigates the effect of comprehensive cardiac rehabilitation versus usual care for patients treated for IE.We will conduct a randomised clinical trial to investigate the effects of comprehensive cardiac rehabilitation versus usual care on the physical and psychosocial functioning of patients treated for IE. The trial is a multicentre, parallel design trial with 1 : 1 individual randomisation to either the intervention or control group. The intervention consists of five psychoeducational consultations provided by specialised nurses and a 12-week exercise training programme. The primary outcome is mental health (MH) measured by the standardised Short Form 36 (SF-36). The secondary outcome is peak oxygen uptake measured by the bicycle ergospirometry test. Furthermore, a number of exploratory analyses will be performed. Based on sample size calculation, 150 patients treated for left-sided (native or prosthetic valve) or cardiac device endocarditis will be included in the trial. A qualitative and a survey-based complementary study will be undertaken, to investigate postdischarge experiences of the patients. A qualitative postintervention study will explore rehabilitation participation experiences.The study complies with the Declaration of Helsinki and was approved by the regional research ethics committee (no H-1-2011-129) and the Danish Data Protection Agency (no 2007-58-0015). Study findings will be disseminated widely through peer-reviewed publications and conference presentations.Clinicaltrials.gov identifier: NCT01512615.

Project description:BackgroundMost serious complications of infective endocarditis (IE) appear in the so-called "critical phase" of the disease, which represents the first days after diagnosis. The majority of patients overcoming the acute phase has a favorable outcome, yet they remain hospitalized for a long period of time mainly to complete antibiotic therapy. The major hypothesis of this trial is that in patients with clinically stable IE and adequate response to antibiotic treatment, without signs of persistent infection, periannular complications or metastatic foci, a shorter antibiotic time period would be as efficient and safe as the classic 4 to 6 weeks antibiotic regimen.MethodsMulticenter, prospective, randomized, controlled open-label, phase IV clinical trial with a non-inferiority design to evaluate the efficacy of a short course (2 weeks) of parenteral antibiotic therapy compared with conventional antibiotic therapy (4-6 weeks).Samplepatients with IE caused by gram-positive cocci, having received at least 10 days of conventional antibiotic treatment, and at least 7 days after surgery when indicated, without clinical, analytical, microbiological or echocardiographic signs of persistent infection. Estimated sample size: 298 patients.InterventionControl group: standard duration antibiotic therapy, (4 to 6 weeks) according to ESC guidelines recommendations. Experimental group: short-course antibiotic therapy for 2 weeks. The incidence of the primary composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared.ConclusionsSATIE will investigate whether a two weeks short-course of intravenous antibiotics in patients with IE caused by gram-positive cocci, without signs of persistent infection, is not inferior in safety and efficacy to conventional antibiotic treatment (4-6 weeks).Trial registrationClinicalTrials.gov Identifier: NCT04222257 (January 7, 2020). EudraCT 2019-003358-10.

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Long-Term Results of Early Surgery versus Conventional Treatment for Infective Endocarditis Trial.

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Long-Term Results of Early Surgery versus Conventional Treatment for Infective Endocarditis Trial.

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