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A randomized trial comparing lung-volume—reduction surgery with medical therapy for severe emphysema
Perspective: This and prior studies support that mitral valve repair for degenerative disease results in excellent longterm outcomes and should be preferred in most patients who are candidates for repair. Nevertheless, since incomplete repair is associated with poor long-term outcomes, this technically difficult surgery should best be done in centers with expertise in this procedure. RM
fied (n⫽41 studies with 3327 patients after exclusion). Studies were excluded if they exclusively recruited transplant recipients, individuals ⬍18 years old, or patients with preexisting SVT. Treatment effects and heterogeneity were assessed using the random-effects model and Q test, respectively. Results: Myocardial infarction (odds ratio [OR] 0.58, 95% confidence interval [CI] 0.37– 0.91; p⫽0.02) and ischemia (OR 0.53, 95% CI 0.39 – 0.72; p⬍0.001) were significantly reduced by CAs with a reduction in SVT by non-dihydropyridines (OR 0.62, 95% CI 0.41– 0.93; p⫽0.02). In contrast, mortality during aortocoronary bypass surgery was not affected by CAs (OR 0.66, 95% CI 0.26 –1.70, p⫽0.4). Conclusions: Use of CAs during cardiac surgery significantly reduces MI, ischemia and SVT. Perspective: Most studies included in this meta-analysis included a small number of patients (221 or less). Hence, the findings of current study should be considered hypothesis generating rather than definitive. Large scale RCTs evaluating the role of CAs alone and/or vs. other agents (i.e., beta-blockers) in reducing the rates of MI, ischemia or SVT are really needed. RM
A Randomized Trial Comparing Lung-Volume—Reduction Surgery with Medical Therapy for Severe Emphysema National Emphysema Treatment Trial Research Group. N Engl J Med 2003;348:2059 –73. Study Question: What are the criteria for selection, the magnitude and durability of the benefit and the effect on mortality of lung-volume–reduction surgery for the treatment of severe emphysema? Methods: Patients with severe emphysema undergoing pulmonary rehabilitation (n⫽1218) were randomly assigned to undergo lung-volume–reduction surgery or to receive continued medical treatment. Results: Overall mortality was similar in the two groups (0.11 death per person-year in both treatment groups, risk ratio for death in the surgery group, 1.01; p⫽0.90). However, exercise capacity after 24 months improved by more than 10 W in more patients in the surgery group than in the medical group (15% vs. 3%, p⬍0.001). Overall mortality in the two groups remained similar after exclusion of a subgroup of 140 patients at high risk for death from surgery according to an interim analysis (risk ratio for death in surgery group, 0.89; p⫽0.31). The exercise capacity after 24 months had improved by more than 10 W in 16% of patients in the surgery group, as compared with 3% of patients in the medical-therapy group (p⬍0.001). Mortality was significantly lower in the surgery group than in the medical-therapy group among patients with predominantly upper-lobe emphysema and low exercise capacity (risk ratio for death, 0.47; p⫽0.005). In contrast, among patients with non– upper-lobe emphysema and high exercise capacity, surgical treatment was associated with a higher mortality than in the medical-therapy group (risk ratio, 2.06; p⫽0.02). Conclusions: Lung-volume–reduction surgery increases the exercise capacity over medical therapy. However, it does not confer a survival advantage with the possible exception of patients with both predominantly upper-lobe emphysema and low baseline exercise capacity. Patients at high risk and those with non– upper-lobe emphysema and high baseline exercise capacity are poor candidates for lungvolume–reduction surgery, because of increased mortality and negligible functional gain. Perspective: This large randomized trial identifies a subset of patients with severe emphysema who are likely to show survival advantage with lung-volume–reduction surgery. RM
Recurrence of Mitral Valve Regurgitation After Mitral Valve Repair in Degenerative Valve Disease Flameng W, Herijgers P, Bogaerts K. Circulation 2003;107:1609 –13. Study Question: What is the recurrence of mitral regurgitation in terms of incidence and degree on follow-up after successful mitral valve repair for degenerative disease as assessed by serial echocardiography? Methods: Patients (n⫽242) undergoing mitral valve repair for degenerative valve incompetence had serial echocardiographic follow-up of valve function, and the rate of reoperation, survival and clinical outcome was studied. Results: Survival (90.9⫾3.2%), freedom from reoperation (94.2⫾2.3%) and freedom from anticoagulation bleeding and thromboembolic events (90.4⫾2.7%) were excellent at 8 years. However, echocardiography revealed that freedom from non-trivial mitral regurgitation (⬎1/4) was 94.3⫾1.6% at 1 month, 58.6⫾4.9% at 5 years and 27.2⫾8.6% at 7 years. Comparative figures for the freedom from severe mitral regurgitation (⬎2/4) were 98.3⫾0.9%, 82.8⫾3.8% and 71.1⫾7.4% at 1, 5 and 7 years, respectively. The linearized recurrence rate of non-trivial mitral regurgitation (⬎1/4) was 8.3% per year and of severe mitral regurgitation (⬎2/4) was 3.7% per year. In patients with adequate surgical techniques (chordal shortening, use of annuloplasty ring or sliding plasty) the linearized recurrence rates were 6.9% per year and 2.5% per year, respectively. Conclusion: Clinical outcomes of mitral valve repair are excellent, although a significant degree of mitral valve regurgitation (⬎2/4) occurs in a third of patients. This information should be taken into account when asymptomatic patients are offered early mitral valve repair.
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85
fied (n⫽41 studies with 3327 patients after exclusion). Studies were excluded if they exclusively recruited transplant recipients, individuals ⬍18 years old, or patients with preexisting SVT. Treatment effects and heterogeneity were assessed using the random-effects model and Q test, respectively. Results: Myocardial infarction (odds ratio [OR] 0.58, 95% confidence interval [CI] 0.37– 0.91; p⫽0.02) and ischemia (OR 0.53, 95% CI 0.39 – 0.72; p⬍0.001) were significantly reduced by CAs with a reduction in SVT by non-dihydropyridines (OR 0.62, 95% CI 0.41– 0.93; p⫽0.02). In contrast, mortality during aortocoronary bypass surgery was not affected by CAs (OR 0.66, 95% CI 0.26 –1.70, p⫽0.4). Conclusions: Use of CAs during cardiac surgery significantly reduces MI, ischemia and SVT. Perspective: Most studies included in this meta-analysis included a small number of patients (221 or less). Hence, the findings of current study should be considered hypothesis generating rather than definitive. Large scale RCTs evaluating the role of CAs alone and/or vs. other agents (i.e., beta-blockers) in reducing the rates of MI, ischemia or SVT are really needed. RM
A Randomized Trial Comparing Lung-Volume—Reduction Surgery with Medical Therapy for Severe Emphysema National Emphysema Treatment Trial Research Group. N Engl J Med 2003;348:2059 –73. Study Question: What are the criteria for selection, the magnitude and durability of the benefit and the effect on mortality of lung-volume–reduction surgery for the treatment of severe emphysema? Methods: Patients with severe emphysema undergoing pulmonary rehabilitation (n⫽1218) were randomly assigned to undergo lung-volume–reduction surgery or to receive continued medical treatment. Results: Overall mortality was similar in the two groups (0.11 death per person-year in both treatment groups, risk ratio for death in the surgery group, 1.01; p⫽0.90). However, exercise capacity after 24 months improved by more than 10 W in more patients in the surgery group than in the medical group (15% vs. 3%, p⬍0.001). Overall mortality in the two groups remained similar after exclusion of a subgroup of 140 patients at high risk for death from surgery according to an interim analysis (risk ratio for death in surgery group, 0.89; p⫽0.31). The exercise capacity after 24 months had improved by more than 10 W in 16% of patients in the surgery group, as compared with 3% of patients in the medical-therapy group (p⬍0.001). Mortality was significantly lower in the surgery group than in the medical-therapy group among patients with predominantly upper-lobe emphysema and low exercise capacity (risk ratio for death, 0.47; p⫽0.005). In contrast, among patients with non– upper-lobe emphysema and high exercise capacity, surgical treatment was associated with a higher mortality than in the medical-therapy group (risk ratio, 2.06; p⫽0.02). Conclusions: Lung-volume–reduction surgery increases the exercise capacity over medical therapy. However, it does not confer a survival advantage with the possible exception of patients with both predominantly upper-lobe emphysema and low baseline exercise capacity. Patients at high risk and those with non– upper-lobe emphysema and high baseline exercise capacity are poor candidates for lungvolume–reduction surgery, because of increased mortality and negligible functional gain. Perspective: This large randomized trial identifies a subset of patients with severe emphysema who are likely to show survival advantage with lung-volume–reduction surgery. RM
Recurrence of Mitral Valve Regurgitation After Mitral Valve Repair in Degenerative Valve Disease Flameng W, Herijgers P, Bogaerts K. Circulation 2003;107:1609 –13. Study Question: What is the recurrence of mitral regurgitation in terms of incidence and degree on follow-up after successful mitral valve repair for degenerative disease as assessed by serial echocardiography? Methods: Patients (n⫽242) undergoing mitral valve repair for degenerative valve incompetence had serial echocardiographic follow-up of valve function, and the rate of reoperation, survival and clinical outcome was studied. Results: Survival (90.9⫾3.2%), freedom from reoperation (94.2⫾2.3%) and freedom from anticoagulation bleeding and thromboembolic events (90.4⫾2.7%) were excellent at 8 years. However, echocardiography revealed that freedom from non-trivial mitral regurgitation (⬎1/4) was 94.3⫾1.6% at 1 month, 58.6⫾4.9% at 5 years and 27.2⫾8.6% at 7 years. Comparative figures for the freedom from severe mitral regurgitation (⬎2/4) were 98.3⫾0.9%, 82.8⫾3.8% and 71.1⫾7.4% at 1, 5 and 7 years, respectively. The linearized recurrence rate of non-trivial mitral regurgitation (⬎1/4) was 8.3% per year and of severe mitral regurgitation (⬎2/4) was 3.7% per year. In patients with adequate surgical techniques (chordal shortening, use of annuloplasty ring or sliding plasty) the linearized recurrence rates were 6.9% per year and 2.5% per year, respectively. Conclusion: Clinical outcomes of mitral valve repair are excellent, although a significant degree of mitral valve regurgitation (⬎2/4) occurs in a third of patients. This information should be taken into account when asymptomatic patients are offered early mitral valve repair.
ACC CURRENT JOURNAL REVIEW Jul/Aug 2003
85