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Early Surgery versus Conventional Treatment for Infective Endocarditis
N Engl J Med 2012;366: Early Surgery versus Conventional Treatment for Infective Endocarditis Duk-Hyun Kang, M.D., Ph.D., Yong-Jin Kim, M.D., Ph.D., Sung-Han Kim, M.D., Ph.D., Byung Joo Sun, M.D., Dae-Hee Kim M.D., Ph.D., Sung-Cheol Yun, Ph.D., Jong-Min Song, M.D., Ph.D., Suk Jung Choo, M.D., Ph.D., Cheol-Hyun Chung, M.D., Ph.D., Jae-Kwan Song, M.D., Ph.D., Jae-Won Lee, M.D., Ph.D., and Dae-Won Sohn, M.D., Ph.D. R3 Kim Se-yun/ prof Ha Sang-jin
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considerable risk of death and morbidity.
BACKGROUND considerable risk of death and morbidity. Infectious Endocarditis Medical treatment : IV antibiotics Surgical treatment : excision of infected tissue & valve repair 2006 American College of Cardiology–American Heart Association (ACC–AHA) guidelines recommend early surgery as a class IIa indication only in patients with recurrent emboli and persistent vegetation revised 2009 European Society of Cardiology guidelines recommend early surgery as a class IIb indication in patients with isolated, very large vegetations (>15 mm in diameter)
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BACKGROUND No randomized trial has been conducted to clarify the indications for surgery and the timing of it that would associated with favorable outcomes The Early Surgery versus Conventional Treatment in Infective Endocarditis (EASE) trial to compare the clinical outcomes of early surgery with those of a conventional-treatment strategy based on current guidelines for patients with left-sided infective endocarditis and a high risk of embolism.
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METHODS STUDY DESIGN prospective, randomized trial
From September 2006 through March 2011 infective endocarditis : both early surgery and conventional treatment at two medical centers in Korea. enrolled at the Asan Medical Center (71 patients) and Seoul National University Hospital (5) in Korea
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METHODS PATIENT SELECTION
18 years of age or older, with left-sided, native-valve infective endocarditis and a high risk of embolism Blood cultures and transthoracic echocardiography within 24 hours after hospitalization Diagnosis : the modified Duke criteria severe mitral valve or aortic valve disease and vegetation with a diameter greater than 10 mm Exclusion criteria moderate-to-severe congestive heart failure heart block, annular or aortic abscess, destructive penetrating lesions requiring urgent surgery, or fungal endocarditis age of more than 80 years, coexisting major embolic stroke with a risk of hemorrhagic transformation at the time of diagnosis, and a serious coexisting condition (e.g., cancer)
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METHODS STUDY PROCEDURES
Evaluation at baseline data demographic characteristics, predisposing heart disease, manifestations of infective endocarditis, results of blood cultures, use of antibiotic therapy, results of echocardiography, results of radiologic imaging studies, and operative risk At baseline : transesophageal echocardiography and computed tomography of the brain and abdomen ( using contrast) early-surgery group :surgery within 48 hours after randomization conventional-treatment group : according to the AHA guidelines During followed hospitalization ; at 4 weeks, 6 weeks, 3 months, 6 months, and 1 year; and at 6-month intervals thereafter until September 2011.
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METHODS STUDY END POINTS primary end point secondary end points
: a composite of inhospital death or clinical embolic events that occurred within 6 weeks after randomization secondary end points : at 6 months of follow-up, - death from any cause, embolic events, recurrence of infective endocarditis repeat hospitalization due to congestive heart failure.
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METHODS STATISTICAL ANALYSIS
the Mann–Whitney U test for continuous variables Fisher’s exact test for categorical variables Cox proportional-hazards regression analyses for the outcomes Kaplan–Meier method, log-rank test P value of 0.05 was considered to indicate statistical significance.
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Figure 1. Study Enrollment.
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RESULTS CHARACTERISTICS OF THE PATIENTS
Table 1. Clinical and Echocardiographic Characteristics of the Patients at Baseline, According to Treatment Group.
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RESULTS Table 2. Characteristics of Antibiotic Therapy, According to Treatment Group.
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RESULTS SURGICAL PROCEDURES
All patients in the early-surgery group underwent valve surgery within 48 hours after randomization the median time between randomization and surgery : 24 hours MV repair : 8 patients 22 patients ;mitral valve involve MV replacement ( mechanical valve) : 14 patients early-surgery group : 37 patients AV replacement (mechanical valve) : 14 patients 15 patients ; aortic valve aortic & mitral valve MV replacement (biologic prosthesis) : 1 patients
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RESULTS SURGICAL PROCEDURES
77% ( 30pt) underwent surgery during the initial hospitalization (27patients) Or during follow-up(3patients) conventional-treatment group : 39 patients MV repair : 11 patients MV replacement : 6 patients MV repair + AV replacement : 2 patients AV replacement : 11 patients
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RESULTS SURGICAL PROCEDURES
77% ( 30pt) underwent surgery during the initial hospitalization (27patients) Or during follow-up(3patients) conventional-treatment group : 39 patients urgent surgery ( 8 patients) :, 6.5 days after randomization( mean time) TIMING Elective surgery ( 22 patients) : more than 2 weeks after randomization
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RESULTS PRIMARY & SECONDARY END POINT
Table 3. Clinical End Points.
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RESULTS Figure 2. Kaplan–Meier Curves for the Cumulative Probabilities of Death and of the Composite End Point at 6 Months, According to Treatment Group..
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CONCLUSION As compared with conventional treatment,
early surgery in patients with infective endocarditis and large vegetations significantly reduced the composite end point of death from any cause and embolic events by effectively decreasing the risk of systemic embolism.
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