Dataset Information

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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Publications

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.

Dataset Information

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

Background and objectives

Subjects and methods

Results

Conclusion

Publications

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

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