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Hypertrophic Obstructive Cardiomyopathy: Comparison of Outcomes After Myectomy or Alcohol Ablation Adjusted by Propensity Score
Cardiovascular Surgery
Study Question: The aim of the present analysis was to compare myectomy or alcohol ablation for patients with hypertrophic obstructive cardiomyopathy to assess their effects on symptoms and hemodynamics. Methods: One hundred fifty patients underwent intervention for hypertrophic obstructive cardiomyopathy. Sixty patients elected to have alcohol ablation, and 5 crossed over to surgical intervention. A total of 95 patients had a myectomy. Patients having an isolated myectomy (n⫽48) were compared with those who had an ablation. Differences in clinical and hemodynamic outcomes between achieved treatment groups were compared after adjustment for differing baseline patient characteristics, including use of a propensity score, to adjust for the nonrandomization. Results: The patients undergoing alcohol ablation (n⫽60) were older (58 vs. 48 years) and had fewer associated lesions (1 vs. 39 patients), lower pressure gradients (67 vs. 73 mm Hg), and similar symptomatic status and degrees of mitral regurgitation compared with those in the myectomy group. Alcohol ablation was abandoned in 6 patients, 5 of whom underwent myectomy. Among the completed alcohol ablations, there were 5 late deaths, and 1 other patient was referred for myectomy. One late death occurred after myectomy. At latest follow-up, 3-year survival is 97%, and 92% of the patients are in NYHA functional class I or II. Adjusted comparisons showed significantly lower postintervention left ventricular outflow gradients at rest in the myectomy group (5 vs. 15 mm Hg), with provocation (14 vs. 42 mm Hg), mitral systolic anterior motion (67% vs. 29%), and NYHA functional class. No significant difference was present in postintervention septal thickness or freedom from postintervention pacing, although in time-related analysis, the 3-year freedom from pacing is 88% versus 59% (p⫽0.02), favoring myectomy. Conclusions: The investigators concluded that either alcohol ablation or myectomy offers substantial clinical improvement for patients with hypertrophic obstructive cardiomyopathy, but hemodynamic resolution of the obstruction and its sequelae is more complete with myectomy. Perspective: This analysis suggests that clinical outcomes after isolated surgical myectomy may be better than those after alcohol ablation. However, the study compared the performance of two procedures with differing patient referral patterns without randomization, and follow-up was relatively short, with small numbers of patients. A prospective multicenter trial of the two modalities of treatment is needed to determine the optimal management of patients with the obstructive form of hypertrophic cardiomyopathy. DB
Abstracts Complications of the COX-2 Inhibitors Parecoxib and Valdecoxib After Cardiac Surgery Nussmeier NA, Whelton AA, Brown MT, et al. N Engl J Med 2005;352:1081–91. Study Question: What is the safety of valdecoxib (Bextra) and its intravenous prodrug parecoxib when used for treating postoperative pain after cardiac surgery? Methods: A total of 1671 patients undergoing coronary artery bypass grafting (CABG) were randomly assigned to three groups to receive intravenous (IV) parecoxib for at least 3 days, followed by oral valdecoxib through day 10; IV placebo followed by oral valdecoxib; or placebo for 10 days. This double-blind study involved 10 days of treatment and 30 days of follow-up. All patients were also allowed to use standard opioid medications. The primary end point was the frequency of predefined adverse events (including cardiovascular events, renal failure or dysfunction, gastroduodenal ulceration, and wound-healing complications). Results: The study investigators found that both the groups given COX-2 inhibitors (i.e., the parecoxib and valdecoxib group and the group given placebo and valdecoxib) had a higher proportion of adverse events compared to placebo group (7.4% in each of these two groups vs. 4.0% in the placebo group; risk ratio [RR] for each comparison, 1.9; 95% confidence interval [CI] 1.1–3.2; p⫽0.02 for each comparison with the placebo group). Cardiovascular events (including cardiac arrest, stroke, myocardial infarction and pulmonary embolism) were more frequent among patients given parecoxib and valdecoxib than among those given placebo (2.0% vs. 0.5%; RR 3.7; 95% CI 1.0 –13.5; p⫽0.03). Conclusions: These investigators concluded that the increased evidence of cardiovascular events associated with use of parecoxib and valdecoxib raises concern about use of these drugs in managing postoperative pain following CABG. Perspective: Earlier studies of the use of valdecoxib in arthritis did not demonstrate increased cardiovascular events. This study suggests that high-dose valdecoxib (up to 8 times the dose in arthritis) is associated with an increase in cardiovascular events when used in management of postoperative pain following CABG. These findings raise the concern that lowdose COX-2 inhibitors may also be associated with adverse cardiovascular events. Also, the possibility arises that conventional NSAIDS have similar effects. RB
Hypertrophic Obstructive Cardiomyopathy: Comparison of Outcomes After Myectomy or Alcohol Ablation Adjusted by Propensity Score
Endovascular Treatment of Thoracic Aortic Aneurysms: Results of the Phase II Multicenter Trial of the GORE TAG Thoracic Endoprosthesis
Ralph-Edwards A, Woo A, McCrindle BW, et al. J Thorac Cardiovasc Surg 2005;129:351– 8.
Makaroun MS, Dillavou ED, Kee ST, et al. J Vasc Surg 2005;41: 1–9.
ACC CURRENT JOURNAL REVIEW June 2005
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Study Question: The aim of the present analysis was to compare myectomy or alcohol ablation for patients with hypertrophic obstructive cardiomyopathy to assess their effects on symptoms and hemodynamics. Methods: One hundred fifty patients underwent intervention for hypertrophic obstructive cardiomyopathy. Sixty patients elected to have alcohol ablation, and 5 crossed over to surgical intervention. A total of 95 patients had a myectomy. Patients having an isolated myectomy (n⫽48) were compared with those who had an ablation. Differences in clinical and hemodynamic outcomes between achieved treatment groups were compared after adjustment for differing baseline patient characteristics, including use of a propensity score, to adjust for the nonrandomization. Results: The patients undergoing alcohol ablation (n⫽60) were older (58 vs. 48 years) and had fewer associated lesions (1 vs. 39 patients), lower pressure gradients (67 vs. 73 mm Hg), and similar symptomatic status and degrees of mitral regurgitation compared with those in the myectomy group. Alcohol ablation was abandoned in 6 patients, 5 of whom underwent myectomy. Among the completed alcohol ablations, there were 5 late deaths, and 1 other patient was referred for myectomy. One late death occurred after myectomy. At latest follow-up, 3-year survival is 97%, and 92% of the patients are in NYHA functional class I or II. Adjusted comparisons showed significantly lower postintervention left ventricular outflow gradients at rest in the myectomy group (5 vs. 15 mm Hg), with provocation (14 vs. 42 mm Hg), mitral systolic anterior motion (67% vs. 29%), and NYHA functional class. No significant difference was present in postintervention septal thickness or freedom from postintervention pacing, although in time-related analysis, the 3-year freedom from pacing is 88% versus 59% (p⫽0.02), favoring myectomy. Conclusions: The investigators concluded that either alcohol ablation or myectomy offers substantial clinical improvement for patients with hypertrophic obstructive cardiomyopathy, but hemodynamic resolution of the obstruction and its sequelae is more complete with myectomy. Perspective: This analysis suggests that clinical outcomes after isolated surgical myectomy may be better than those after alcohol ablation. However, the study compared the performance of two procedures with differing patient referral patterns without randomization, and follow-up was relatively short, with small numbers of patients. A prospective multicenter trial of the two modalities of treatment is needed to determine the optimal management of patients with the obstructive form of hypertrophic cardiomyopathy. DB
Abstracts Complications of the COX-2 Inhibitors Parecoxib and Valdecoxib After Cardiac Surgery Nussmeier NA, Whelton AA, Brown MT, et al. N Engl J Med 2005;352:1081–91. Study Question: What is the safety of valdecoxib (Bextra) and its intravenous prodrug parecoxib when used for treating postoperative pain after cardiac surgery? Methods: A total of 1671 patients undergoing coronary artery bypass grafting (CABG) were randomly assigned to three groups to receive intravenous (IV) parecoxib for at least 3 days, followed by oral valdecoxib through day 10; IV placebo followed by oral valdecoxib; or placebo for 10 days. This double-blind study involved 10 days of treatment and 30 days of follow-up. All patients were also allowed to use standard opioid medications. The primary end point was the frequency of predefined adverse events (including cardiovascular events, renal failure or dysfunction, gastroduodenal ulceration, and wound-healing complications). Results: The study investigators found that both the groups given COX-2 inhibitors (i.e., the parecoxib and valdecoxib group and the group given placebo and valdecoxib) had a higher proportion of adverse events compared to placebo group (7.4% in each of these two groups vs. 4.0% in the placebo group; risk ratio [RR] for each comparison, 1.9; 95% confidence interval [CI] 1.1–3.2; p⫽0.02 for each comparison with the placebo group). Cardiovascular events (including cardiac arrest, stroke, myocardial infarction and pulmonary embolism) were more frequent among patients given parecoxib and valdecoxib than among those given placebo (2.0% vs. 0.5%; RR 3.7; 95% CI 1.0 –13.5; p⫽0.03). Conclusions: These investigators concluded that the increased evidence of cardiovascular events associated with use of parecoxib and valdecoxib raises concern about use of these drugs in managing postoperative pain following CABG. Perspective: Earlier studies of the use of valdecoxib in arthritis did not demonstrate increased cardiovascular events. This study suggests that high-dose valdecoxib (up to 8 times the dose in arthritis) is associated with an increase in cardiovascular events when used in management of postoperative pain following CABG. These findings raise the concern that lowdose COX-2 inhibitors may also be associated with adverse cardiovascular events. Also, the possibility arises that conventional NSAIDS have similar effects. RB
Hypertrophic Obstructive Cardiomyopathy: Comparison of Outcomes After Myectomy or Alcohol Ablation Adjusted by Propensity Score
Endovascular Treatment of Thoracic Aortic Aneurysms: Results of the Phase II Multicenter Trial of the GORE TAG Thoracic Endoprosthesis
Ralph-Edwards A, Woo A, McCrindle BW, et al. J Thorac Cardiovasc Surg 2005;129:351– 8.
Makaroun MS, Dillavou ED, Kee ST, et al. J Vasc Surg 2005;41: 1–9.
ACC CURRENT JOURNAL REVIEW June 2005
39