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. (EASE ClinicalTrials.gov number, NCT00750373.).
Background: The morbidity and mortality of patients with functional mitral regurgitation (MR) remain high, but no pharmacological therapy has been proven effective. The hypothesis of this study was that sacubitril/valsartan would be superior to valsartan alone in improving functional MR via dual inhibition of the renin-angiotensin system and neprilysin. Methods: In this double-blind trial, we randomly assigned 118 patients with heart failure with chronic functional MR secondary to left ventricular (LV) dysfunction to receive either sacubitril/valsartan or valsartan, in addition to standard medical therapy for heart failure. The primary end point was the change in effective regurgitant orifice area of functional MR from baseline to the 12-month follow-up. Secondary end points included changes in regurgitant volume, LV end-systolic volume, LV end-diastolic volume, and incomplete mitral leaflet closure area. Results: The decrease in effective regurgitant orifice area was significantly greater in the sacubitril/valsartan group than in the valsartan group (–0.058±0.095 versus –0.018±0.105 cm 2 ; P =0.032) in an intention-to-treat analysis including 117 (99%) patients. Regurgitant volume was also significantly decreased in the sacubitril/valsartan group in comparison with the valsartan group (mean difference, –7.3 mL; 95% CI, –12.6 to –1.9; P =0.009). There were no significant between-group differences regarding the changes in incomplete mitral leaflet closure area and LV volumes, with the exception of LV end-diastolic volume index ( P =0.044). We noted no significant difference in the change of blood pressure between the treatment groups, and 7 patients (12%) in the sacubitril/valsartan group and 9 (16%) in the valsartan group had ≥1 serious adverse events ( P =0.54). Conclusions: Among patients with secondary functional MR, sacubitril/valsartan reduced MR to a greater extent than did valsartan. Our findings suggest that an angiotensin receptor-neprilysin inhibitor might be considered for optimal medical therapy of patients with heart failure and functional MR. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02687932.
Background-The optimal timing of surgical intervention in asymptomatic patients with severe mitral regurgitation is unclear. We therefore compared the long-term results of early surgery with a conventional treatment strategy. Methods and Results-From 1996 to 2005, 447 consecutive asymptomatic patients (253 men, age 50Ϯ15 years) with severe degenerative mitral regurgitation and preserved left ventricular function were evaluated prospectively. The end point was defined as the composite of operative mortality, cardiac death, repeat mitral valve surgery, and urgent admission due to congestive heart failure during follow-up. Early surgery was performed on 161 patients (operated group), and the conventional treatment strategy was used for 286 patients (conventional treatment group). There were no significant differences between the 2 groups in terms of age, gender, euroSCORE (European System for Cardiac Operative Risk Evaluation), or ejection fraction. During a median follow-up of 1988 days, there were 2 repeat surgeries and no cardiac deaths or operative mortality in the operated group compared with 12 cardiac deaths, 1 repeat surgery, and 22 admissions for congestive heart failure in the conventional treatment group. The estimated actuarial 7-year cardiac mortality rate was 0% in the operated group and 5Ϯ2% in the conventional treatment group (Pϭ0.008), and for 127 propensity score-matched pairs, the estimated actuarial 7-year event-free survival rate was significantly higher in the operated than in the conventional treatment group (99Ϯ1% versus 85Ϯ4%, Pϭ0.007). In the conventional treatment group, baseline grade of pulmonary hypertension (hazard ratio 1.87, 95% CI 1.22 to 2.87, Pϭ0.003), age (hazard ratio 1.02, 95% CI 1.01 to 1.04, Pϭ0.005), and effective regurgitant orifice area (hazard ratio 2.06, 95% CI 1.11 to 3.82, Pϭ0.02) were independent variables that predicted late development of surgical indications or congestive heart failure on Cox multivariate analysis. Conclusions-Compared with conservative management, the strategy of early surgery was associated with an improved long-term event rate by decreasing cardiac mortality and congestive heart failure hospitalization more effectively in patients with severe degenerative mitral regurgitation. Early surgery may therefore further improve clinical outcomes in asymptomatic severe mitral regurgitation with preserved left ventricular systolic function and a high likelihood of mitral valve repair. (Circulation. 2009;119:797-804.)
Background-The proper treatment option for patients with type A intramural hematoma (IMH), a variant form of classic aortic dissection (AD), remains controversial. We assessed the outcome of our institutional policy of urgent surgery for unstable patients and initial medical treatment for stable patients with surgery in cases with complications. .56). The 1-, 2-, and 3-year survival rates of IMH patients were 87.6Ϯ3.6%, 84.9Ϯ3.7%, and 83.1Ϯ4.1%, respectively. There was no statistical difference of overall survival rates between patients with IMH and surgically treated AD patients (Pϭ0.787). Conclusions-The clinical outcome of IMH patients receiving treatment by our policy was comparable to that of surgically treated AD patients. However, adverse clinical events were not uncommon with medical treatment alone, and initial aorta diameter and hematoma thickness may identify patients who might benefit from urgent surgery.
The patterns of valvular dysfunction and bicuspid aortopathy differed significantly between the 2 BAV phenotypes, suggesting the possibility of etiologically different entities.
Background-The optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. We therefore compared the long-term results of early surgery and a conventional treatment strategy. Methods and Results-From 1996 to 2006, we prospectively included a total of 197 consecutive asymptomatic patients (99 men; age, 63Ϯ12 years) with very severe aortic stenosis. Patients were excluded if they had angina, syncope, exertional dyspnea, ejection fraction Ͻ0.50, significant mitral valve disease, or age Ͼ85 years. Very severe aortic stenosis was defined as a critical stenosis in the aortic valve area Յ0.75 cm 2 accompanied by a peak aortic jet velocity Ն4.5 m/s or a mean transaortic pressure gradient Ն50 mm Hg on Doppler echocardiography. The primary end point was defined as the composite of operative mortality and cardiac death during follow-up. Early surgery was performed on 102 patients, and a conventional treatment strategy was used for 95 patients. There were no significant differences between the 2 groups in terms of age, gender, European System for Cardiac Operative Risk Evaluation score, or ejection fraction. During a median follow-up of 1501 days, the operated group had no operative mortalities, no cardiac deaths, and 3 noncardiac deaths; the conventional treatment group had 18 cardiac and 10 noncardiac deaths. The estimated actuarial 6-year cardiac and all-cause mortality rates were 0% and 2Ϯ1% in the operated group and 24Ϯ5% and 32Ϯ6% in the conventional treatment group, respectively (PϽ0.001), and for 57 propensity score-matched pairs, the risk of all-cause mortality was significantly lower in the operated group than in the conventional treatment group (hazard ratio, 0.135; 95% confidence interval, 0.030 to 0.597; Pϭ0.008). Conclusions-Compared with the conventional treatment strategy, early surgery in patients with very severe aortic stenosis is associated with an improved long-term survival by decreasing cardiac mortality. Early surgery is therefore a therapeutic option to further improve clinical outcomes in asymptomatic patients with very severe aortic stenosis and low operative risk. (Circulation. 2010;121:1502-1509.)
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