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Long-term results after directional atherectomy of femoro-popliteal lesions
638 Abstracts
CI, 1.7 to 3.9). The effect of PlGF on the composite end point remained significant with adjustments for high sensitivity C reactive protein, troponin levels, and soluble CD4 40 ligand (adjusted HR, 3.3; 95% CI, 2.0 to 5.4). Comment: Accumulating data suggest C-reactive protein may not be all that specific in predicting future cardiovascular events in individual patients. Perhaps PlGF will serve as a more specific marker of vascular inflammation and a more powerful predictor of vascular events. There will undoubtedly be additional studies evaluating the role of PlGF vs other markers of inflammation predicting future cardiovascular events in various subsets of patients with atherosclerosis. The importance of this in the individual patient is unknown. (See also the abstract “Multiple biomarkers for the prediction of first major cardiovascular events and death” in this month’s abstract section of the Journal of Vascular Surgery.)
Long-term results after directional atherectomy of femoro-popliteal lesions Zeller T, Rastan A, Sixt S, et al. J Am Coll Cardiol 2006;48:1573-8. Conclusion: Directional atherectomy of femoropopliteal lesions provides overall better results when applied to de novo lesions than restenotic lesions. Summary: The authors sought to evaluate long-term results of directional atherectomy using the Silverhawk device (FoxHollow Technologies, Redwood City, Calif). The study included 84 patients, 100 legs, and 131 lesions in the femoropopliteal distribution. Ischemia classification was between 2 and 5 based on the Rutherford classification system. Of the lesions treated, 45 were de novo lesions (group 1), 43 were native vessel restenoses (group 2), and 43 were in-stent restenoses (group 3). In addition to directional atherectomy, balloon angioplasty was used in 78 (59%) of 131 lesions and stents were placed across eight lesions (6%). Primary patency was defined as freedom from a ⬎50% restenoses as assessed by duplex scanning. Technical success was achieved in 86% of atherectomy-only procedures. Technical success was 100% after additional therapy. Mean lesion lengths were 43 ⫾ 54 mm in group 1, 105 ⫾ 122 mm in group 2, and 131 ⫾ 111 mm in group 3 (P ⬍ .001). Primary patency was 84% for group 1, 54% for group 2, and 54% for group 3 at 12 months (P ⫽ .002) and 73%, 42%, and 49%, respectively, at 18 months (P ⫽ .008). Secondary patency rates were 100%, 93%, and 91% at 12 months (P ⫽ NS); and 89%, 67%, and 79% at 18 months (P ⫽ .001) for groups 1, 2, and 3, respectively. The ankle-brachial index was improved after 12 months and after 18 months in all groups. Treatment of restenotic lesions was the only independent predictor of restenosis. Comment: The results presented here for use of the Silverhawk catheter for treatment of de novo femoropopliteal lesions are similar to results obtained treating femoropopliteal lesions with bare and drug-coated stents (J Vasc Intervent Radiol 2005;16:331-8). The number of devices and techniques available for catheter-based treatment of the femoropopliteal arteries is expanding rapidly. Without direct head-to-head randomized trails, we have no way of knowing which device or technique will provide the best results. However, with the proprietary interest of industry, the financial interest of stockholders, and the current enthusiasm for catheter-based treatments, such trials are unlikely to be conducted.
Multiple biomarkers for the prediction of first major cardiovascular events and death Wang TJ, Gona P, Larson MG, et al. N Engl J Med 2006;355:2631-9. Conclusion: The use of biomarkers to assess cardiovascular risk in individual patients adds little to risk assessment using standard risk factors. Summary: Multiple biomarkers are now available to assess cardiovascular risk. In individual studies, each appears to be predictive of cardiovascular events to one degree or another. In this study, the authors measured 10 biomarkers in 3209 participants of the Framingham Heart Study. The biomarkers included C-reactive protein, B-type natriuretic peptide, Nterminal proatrial natriuretic peptide, aldosterone, renin, D-dimer, fibrinogen, homocysteine, plasminogen-activator inhibitor type 1, and urinary albumin-to-creatinine ratio. Median follow-up was 7.4 years. During follow-up, 169 participants had a first major cardiovascular event and 207 died. A Cox proportional hazards model was used to adjust for conventional risk factors to predict hazard ratios (HRs) or risk of death for each biomarker. The authors expressed HRs per one standard deviation increment in log values. HRs for each of the biomarkers studied were B-type natriuretic peptide, 1.4; C-reactive protein level, 1.39; urinary albumin-to-creatinine ratio, 1.22; homocysteine level, 1.20; and renin level, 1.17. Considering major cardiovascular events, biomarkers most predictive were the B-type natriuretic peptide level (1.25) and the urinary albumin-to-creatinine ratio (1.20). Comparing persons with multiple markers and scores in the highest quintile with scores in the lowest two quintiles, persons in the highest quintile had an elevated risk of death (adjusted HR, 4.08; P ⬍ .001). They also had a higher risk of major cardiovascular events (adjusted HR, 1.84; P ⫽ .02). The addition of multiple marker scores to assessment of conventional risk factors resulted in only a mild increases in the ability to classify cardiovascular risks in individual patients.
JOURNAL OF VASCULAR SURGERY March 2007
Comment: There is huge interest in risk stratification of patients at risk for cardiovascular events. This interest is spawned from what can be described as a cottage industry of assessment of biomarkers for cardiovascular events. The study confirms that multiple biomarkers are capable of predicting increased cardiovascular risk, but unfortunately, add little to the prediction of risk in individual patients. Routine assessment of biomarkers for cardiovascular risk does not appear warranted.
Outcomes after ruptured abdominal aortic aneurysms: The “halo effect” of trauma center designation Utter GH, Maier RV, Rivara FP, et al. J Am Coll Surg 2006;203:498-505. Conclusion: Patients with ruptured abdominal aortic aneurysm (AAA) treated at a regional trauma center have a lower risk of death and organ failure compared with patients with ruptured AAA treated at nondesignated centers. Summary: Trauma centers have numerous services available around the clock that may help reduce mortality in patients with severe injuries. Such services may also benefit noninjured patients with life-threatening conditions. The authors of this report sought to determine whether patients with ruptured AAA treated at designated trauma centers had better outcomes than those treated at other acute care hospitals. This was a retrospective cohort study comparing mortality or organ failure in patients with ruptured AAA treated at trauma centers vs those treated at nondesignated centers. Trauma centers were considered those to be either level 1 or level 2 as determined by the American College of Surgeons or regional authorities. Acute care hospitals, defined as nontrauma centers, were those that were considered level 3 or level 4 centers (ie, not required to have the resources of a regional trauma center) or those not designated as a trauma center. Patients between 40 and 84 years of age who underwent operation as identified by International Classification of Disease (9th revision) codes during 2001 for ruptured AAA were identified. Patients were drawn from 20 states with organized systems of trauma care. The relative risk of either death or organ failure was compared at regional trauma centers with nondesignated centers. During the study period, 2450 patients were hospitalized for ruptured AAA, with 867 (35%) of these hospitalizations occurring in level 1 or level 2 regional trauma centers. At trauma centers, 41.4% of patients died before hospital discharge. At nondesignated hospitals, 45.2% of patients died before discharge (odds ratio [OR] 0.85; 95% confidence interval [CI], 0.71 to 1.02). With adjustments for hospital beds, annual hospital admissions, inpatient operations, payer mix, affiliation with a vascular surgery fellowship, and comorbid illnesses, the likelihood of death or organ failure was lower at a regional trauma center in patients with ruptured AAA (OR, 0.72; 95% CI, 0.55 to 0.93). Comment: The data suggest patients with ruptured AAA have improved outcome when cared for in trauma centers vs nondesignated centers. The ability to mobilize massive resources, the immediate availability of emergency operative care, and the intense dedication to surgical intensive care at designated trauma centers all likely combine to result in improved outcomes.
Influence of perioperative blood glucose levels on outcome after infrarenal bypass surgery in patients with diabetes Malmstedt J, Wahlberg E, Jorneskog G, et al. Br J Surg 2006;93:1360-7. Conclusion: Poor control of perioperative glucose levels is associated with unfavorable outcomes after infrainguinal bypass surgery in patients with diabetes. Summary: It is well established that high perioperative glucose levels are associated with increased morbidity and mortality in intensive care unit patients and in patients after coronary artery bypass. The authors sought to study the effects of perioperative glucose control in diabetic patients undergoing infrainguinal bypass. Patients were identified from a prospective vascular registry. The study population was 91 consecutive diabetic patients with infrainguinal bypass surgery. Medical records were used to extract risk factors for surgery, indication for surgery, details of the operation, and outcomes. An area under the curve method (AUC) using blood glucose levels obtained after the first 48 hours after surgery was used as the measure of perioperative glucose control. Poor outcome was defined as death, major amputation, or graft occlusion at 90 days. Multivariable analysis indicated that renal insufficiency (odds ratio [OR], 4.77), infected foot ulcer (OR, 3.38), and the AUC for glucose (OR, 15.35, first vs fourth quartile) were all associated with poor outcome. Surgical wound complications at 30 days were associated with AUC for glucose (OR, 14.45, first vs fourth quartile), tissue loss as an indication for surgery (OR, 3.30), and female sex (OR, 3.49). Comment: Adverse effects of hypoglycemia in the perioperative period are impaired coagulation, impaired hemoglobin function, and decreased opsonization. Leukocyte function is also impaired, with impaired phagocytosis and chemoattraction to bacteria. There is no agreement on what is an optimal postoperative blood glucose level in a patient with diabetes. However, based on this study and the bulk of the literature, it would seem that keeping blood glucose levels as close to normal as possible in the perioperative period should be the goal. In many hospitals, this now involves the routine use of insulin drips for surgical patients.
CI, 1.7 to 3.9). The effect of PlGF on the composite end point remained significant with adjustments for high sensitivity C reactive protein, troponin levels, and soluble CD4 40 ligand (adjusted HR, 3.3; 95% CI, 2.0 to 5.4). Comment: Accumulating data suggest C-reactive protein may not be all that specific in predicting future cardiovascular events in individual patients. Perhaps PlGF will serve as a more specific marker of vascular inflammation and a more powerful predictor of vascular events. There will undoubtedly be additional studies evaluating the role of PlGF vs other markers of inflammation predicting future cardiovascular events in various subsets of patients with atherosclerosis. The importance of this in the individual patient is unknown. (See also the abstract “Multiple biomarkers for the prediction of first major cardiovascular events and death” in this month’s abstract section of the Journal of Vascular Surgery.)
Long-term results after directional atherectomy of femoro-popliteal lesions Zeller T, Rastan A, Sixt S, et al. J Am Coll Cardiol 2006;48:1573-8. Conclusion: Directional atherectomy of femoropopliteal lesions provides overall better results when applied to de novo lesions than restenotic lesions. Summary: The authors sought to evaluate long-term results of directional atherectomy using the Silverhawk device (FoxHollow Technologies, Redwood City, Calif). The study included 84 patients, 100 legs, and 131 lesions in the femoropopliteal distribution. Ischemia classification was between 2 and 5 based on the Rutherford classification system. Of the lesions treated, 45 were de novo lesions (group 1), 43 were native vessel restenoses (group 2), and 43 were in-stent restenoses (group 3). In addition to directional atherectomy, balloon angioplasty was used in 78 (59%) of 131 lesions and stents were placed across eight lesions (6%). Primary patency was defined as freedom from a ⬎50% restenoses as assessed by duplex scanning. Technical success was achieved in 86% of atherectomy-only procedures. Technical success was 100% after additional therapy. Mean lesion lengths were 43 ⫾ 54 mm in group 1, 105 ⫾ 122 mm in group 2, and 131 ⫾ 111 mm in group 3 (P ⬍ .001). Primary patency was 84% for group 1, 54% for group 2, and 54% for group 3 at 12 months (P ⫽ .002) and 73%, 42%, and 49%, respectively, at 18 months (P ⫽ .008). Secondary patency rates were 100%, 93%, and 91% at 12 months (P ⫽ NS); and 89%, 67%, and 79% at 18 months (P ⫽ .001) for groups 1, 2, and 3, respectively. The ankle-brachial index was improved after 12 months and after 18 months in all groups. Treatment of restenotic lesions was the only independent predictor of restenosis. Comment: The results presented here for use of the Silverhawk catheter for treatment of de novo femoropopliteal lesions are similar to results obtained treating femoropopliteal lesions with bare and drug-coated stents (J Vasc Intervent Radiol 2005;16:331-8). The number of devices and techniques available for catheter-based treatment of the femoropopliteal arteries is expanding rapidly. Without direct head-to-head randomized trails, we have no way of knowing which device or technique will provide the best results. However, with the proprietary interest of industry, the financial interest of stockholders, and the current enthusiasm for catheter-based treatments, such trials are unlikely to be conducted.
Multiple biomarkers for the prediction of first major cardiovascular events and death Wang TJ, Gona P, Larson MG, et al. N Engl J Med 2006;355:2631-9. Conclusion: The use of biomarkers to assess cardiovascular risk in individual patients adds little to risk assessment using standard risk factors. Summary: Multiple biomarkers are now available to assess cardiovascular risk. In individual studies, each appears to be predictive of cardiovascular events to one degree or another. In this study, the authors measured 10 biomarkers in 3209 participants of the Framingham Heart Study. The biomarkers included C-reactive protein, B-type natriuretic peptide, Nterminal proatrial natriuretic peptide, aldosterone, renin, D-dimer, fibrinogen, homocysteine, plasminogen-activator inhibitor type 1, and urinary albumin-to-creatinine ratio. Median follow-up was 7.4 years. During follow-up, 169 participants had a first major cardiovascular event and 207 died. A Cox proportional hazards model was used to adjust for conventional risk factors to predict hazard ratios (HRs) or risk of death for each biomarker. The authors expressed HRs per one standard deviation increment in log values. HRs for each of the biomarkers studied were B-type natriuretic peptide, 1.4; C-reactive protein level, 1.39; urinary albumin-to-creatinine ratio, 1.22; homocysteine level, 1.20; and renin level, 1.17. Considering major cardiovascular events, biomarkers most predictive were the B-type natriuretic peptide level (1.25) and the urinary albumin-to-creatinine ratio (1.20). Comparing persons with multiple markers and scores in the highest quintile with scores in the lowest two quintiles, persons in the highest quintile had an elevated risk of death (adjusted HR, 4.08; P ⬍ .001). They also had a higher risk of major cardiovascular events (adjusted HR, 1.84; P ⫽ .02). The addition of multiple marker scores to assessment of conventional risk factors resulted in only a mild increases in the ability to classify cardiovascular risks in individual patients.
JOURNAL OF VASCULAR SURGERY March 2007
Comment: There is huge interest in risk stratification of patients at risk for cardiovascular events. This interest is spawned from what can be described as a cottage industry of assessment of biomarkers for cardiovascular events. The study confirms that multiple biomarkers are capable of predicting increased cardiovascular risk, but unfortunately, add little to the prediction of risk in individual patients. Routine assessment of biomarkers for cardiovascular risk does not appear warranted.
Outcomes after ruptured abdominal aortic aneurysms: The “halo effect” of trauma center designation Utter GH, Maier RV, Rivara FP, et al. J Am Coll Surg 2006;203:498-505. Conclusion: Patients with ruptured abdominal aortic aneurysm (AAA) treated at a regional trauma center have a lower risk of death and organ failure compared with patients with ruptured AAA treated at nondesignated centers. Summary: Trauma centers have numerous services available around the clock that may help reduce mortality in patients with severe injuries. Such services may also benefit noninjured patients with life-threatening conditions. The authors of this report sought to determine whether patients with ruptured AAA treated at designated trauma centers had better outcomes than those treated at other acute care hospitals. This was a retrospective cohort study comparing mortality or organ failure in patients with ruptured AAA treated at trauma centers vs those treated at nondesignated centers. Trauma centers were considered those to be either level 1 or level 2 as determined by the American College of Surgeons or regional authorities. Acute care hospitals, defined as nontrauma centers, were those that were considered level 3 or level 4 centers (ie, not required to have the resources of a regional trauma center) or those not designated as a trauma center. Patients between 40 and 84 years of age who underwent operation as identified by International Classification of Disease (9th revision) codes during 2001 for ruptured AAA were identified. Patients were drawn from 20 states with organized systems of trauma care. The relative risk of either death or organ failure was compared at regional trauma centers with nondesignated centers. During the study period, 2450 patients were hospitalized for ruptured AAA, with 867 (35%) of these hospitalizations occurring in level 1 or level 2 regional trauma centers. At trauma centers, 41.4% of patients died before hospital discharge. At nondesignated hospitals, 45.2% of patients died before discharge (odds ratio [OR] 0.85; 95% confidence interval [CI], 0.71 to 1.02). With adjustments for hospital beds, annual hospital admissions, inpatient operations, payer mix, affiliation with a vascular surgery fellowship, and comorbid illnesses, the likelihood of death or organ failure was lower at a regional trauma center in patients with ruptured AAA (OR, 0.72; 95% CI, 0.55 to 0.93). Comment: The data suggest patients with ruptured AAA have improved outcome when cared for in trauma centers vs nondesignated centers. The ability to mobilize massive resources, the immediate availability of emergency operative care, and the intense dedication to surgical intensive care at designated trauma centers all likely combine to result in improved outcomes.
Influence of perioperative blood glucose levels on outcome after infrarenal bypass surgery in patients with diabetes Malmstedt J, Wahlberg E, Jorneskog G, et al. Br J Surg 2006;93:1360-7. Conclusion: Poor control of perioperative glucose levels is associated with unfavorable outcomes after infrainguinal bypass surgery in patients with diabetes. Summary: It is well established that high perioperative glucose levels are associated with increased morbidity and mortality in intensive care unit patients and in patients after coronary artery bypass. The authors sought to study the effects of perioperative glucose control in diabetic patients undergoing infrainguinal bypass. Patients were identified from a prospective vascular registry. The study population was 91 consecutive diabetic patients with infrainguinal bypass surgery. Medical records were used to extract risk factors for surgery, indication for surgery, details of the operation, and outcomes. An area under the curve method (AUC) using blood glucose levels obtained after the first 48 hours after surgery was used as the measure of perioperative glucose control. Poor outcome was defined as death, major amputation, or graft occlusion at 90 days. Multivariable analysis indicated that renal insufficiency (odds ratio [OR], 4.77), infected foot ulcer (OR, 3.38), and the AUC for glucose (OR, 15.35, first vs fourth quartile) were all associated with poor outcome. Surgical wound complications at 30 days were associated with AUC for glucose (OR, 14.45, first vs fourth quartile), tissue loss as an indication for surgery (OR, 3.30), and female sex (OR, 3.49). Comment: Adverse effects of hypoglycemia in the perioperative period are impaired coagulation, impaired hemoglobin function, and decreased opsonization. Leukocyte function is also impaired, with impaired phagocytosis and chemoattraction to bacteria. There is no agreement on what is an optimal postoperative blood glucose level in a patient with diabetes. However, based on this study and the bulk of the literature, it would seem that keeping blood glucose levels as close to normal as possible in the perioperative period should be the goal. In many hospitals, this now involves the routine use of insulin drips for surgical patients.