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Is Early Anticoagulation With Warfarin Necessary After Bioprosthetic Aortic Valve Replacement?
Association of Chronic Kidney Disease With Clinical Outcomes After Coronary Revascularization: The Arterial Revascularization Therapies Study (ARTS)
Methods: Between 1991 and 2004, 332 patients between 45 and 65 years old with isolated aortic valve disease underwent valve replacement with a bioprosthesis. A stentless (Freestyle) valve was used in 140, homograft in 54, stented xenograft (Mosaic or Perimaount) in 62, and a Ross procedure in 76 patients. Results: Perioperative mortality was comparable for all groups (Freestyle, 2.1%; homograft, 3.7%; stented xenograft, 3.2%; Ross procedure, 1.3%; p⫽0.8). Echocardiographically determined hemodynamic performance at discharge was significantly better in the Ross procedure and homograft groups (indexed effective orifice area: Freestyle, 0.9⫾0.3 cm2/m2; homograft, 1.3⫾0.3 cm2/m2; stented xenograft, 0.8⫾0.2 cm2/m2; Ross procedure, 1.4⫾0.4; p⬍0.0001; mean gradient: Freestyle, 12.0⫾6.6 mm Hg; homograft, 7.4⫾4.0 mm Hg; stented xenograft, 15.4⫾5.4 mm Hg; Ross procedure, 4.6⫾3.2 mm Hg; p⬍0.0001). For all yearly follow-up, freedom from New York Heart Association class III or IV was comparable and ⬎95% for all groups. At 7 years, cardiac survival (homograft, 96.3⫾3.7%; Ross procedure, 90.6⫾6.3%; stented xenograft, 86.0⫾10.3%; Freestyle, 89.2⫾10.8%; p⫽0.7) and freedom from reoperation (Ross procedure, 98.5⫾1.4%; homograft, 90.6⫾5.7%; Freestyle, 88.0⫾4.9%; stented xenograft, 90.0⫾8.0%; p⫽0.4) were comparable. Freedom levels from significant bleeding events, valve-related neurologic events, and endocarditis were comparable and ⬎95% for all groups. Conclusions: Aortic bioprosthesis type does not affect midterm survival or valve-related morbidity for the 45- to 65-year-old patient. Perspective: Freedom from adverse events at only 7 years is not adequate to judge the relative benefits of a bioprosthesis in this age group, where 20- and 30-year outcomes (including durability) are of greater interest. Nevertheless, it is reassuring to know that these prostheses all perform well at this short-to-midterm follow-up. The paradox will remain of desiring long-term follow-up for devices that continue to evolve and improve. DB
Ix JH, Mercado N, Shlipak MG, et al. Am Heart J 2005;149:512–9. Study Question: What are the long-term clinical outcomes after coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) with multivessel stenting in patients with chronic renal insufficiency (CRI)? Methods: The Arterial Revascularization Therapies Study (ARTS) randomly assigned 1205 participants with and without CRI either to CABG or PCI with multivessel stenting; CRI was defined as creatinine clearance ⱕ60 mL/min. The primary outcome was the composite end point of death, myocardial infarction (MI), or stroke; a secondary outcome was repeat revascularization. Participants were followed for a mean of 3 years after intervention. Results: At entry into ARTS, 290 patients (25%) had CRI; 151 underwent PCI, and 139 underwent CABG. No difference was observed between CABG or PCI in the primary end point (adjusted hazard ratio [HR] 0.93; 95% CI 0.54 – 1.60; p⫽0.97). However, CABG was associated with a reduced risk for repeat revascularization (HR 0.28; 95% CI 0.14 – 0.54; p⬍0.01). Compared with participants with normal renal function, CRI was associated with a nearly 2-fold risk for the primary outcome (unadjusted HR 1.9; 95% CI 1.4 –2.7; p⬍0.01), which remained significant on multivariate analysis (HR 1.6; 95% CI 1.1–2.4). Conclusions: In patients with multivessel CAD and CRI, treatment with CABG or PCI with multivessel stenting led to similar outcomes of death, MI, or stroke; but CABG was associated with decreased repeat revascularizations. When compared with ARTS participants with normal renal function, CRI was associated with a substantially elevated risk of adverse clinical outcomes after coronary revascularization. Perspective: Chronic renal insufficiency is associated with adverse cardiac outcomes in patients with coronary and valvular heart disease. Although preexisting renal insufficiency is associated with increased operative risk, these data suggest that outcomes are no worse than for percutaneous intervention. In an appropriate population, better freedom from revascularization may favor surgical revascularization in patients with CRI. DB
Is Early Anticoagulation With Warfarin Necessary After Bioprosthetic Aortic Valve Replacement? Sundt TM, Zehr KJ, Dearani JA, et al. J Thorac Cardiovasc Surg 2005;129:1024 –31. Study Question: Is anticoagulation with warfarin necessary for the first 3 months after bioprosthetic aortic valve replacement? Methods: Between 1993 and 2000, 1151 patients at a single institution underwent bioprosthetic aortic valve replacement with (641) or without (510) associated coronary artery bypass. By surgeon preference, 624 subjects had early postoperative anticoagulation and 527 did not. Of those not receiving early anticoagulation, 410 patients (78%) received antiplatelet therapy. Groups with and without early anticoagulation were similar with respect to gender (36% vs. 40% female, p⫽0.21), hypertension (64% vs.
Which Biologic Valve Should We Select for the 45to 65-Year-Old Age Group Requiring Aortic Valve Replacement? Dagenais F, Cartier P, Voisine P, et al. J Thorac Cardiovasc Surg 2005;129:1041–9. Study Question: Is there a preferable type of bioprosthesis for patients 45 to 65 years of age who require aortic valve replacement?
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ence existed between both treatment groups in cumulative freedom from presenting symptom or in freedom from dialysis and renal-related death. Patients who presented with hypertension were more likely to have shown improvement in their blood pressure with endoluminal intervention at 1, 3 and 5 years (59⫾6% endoluminal vs. 83⫾5% open; p⫽0.01). Conclusions: The investigators concluded that both open repair and endoluminal repair of atherosclerotic RAS have similar immediate and long-term functional and anatomic outcomes. Perspective: As reflected in this study, percutaneous intervention is becoming an increasingly popular treatment option for patients with symptoms from atherosclerotic RAS. When compared with open bypass, the procedure offers less morbidity and mortality and at least equivalent survival, primary-assisted patency rates, and functional outcomes. The endoluminal approach appears to be of even greater benefit to those patients with initial hypertension. To confirm the findings in this study and to prove that surgery or endoluminal intervention has a benefit over medical management alone, a prospective, randomized trial must be designed in which endoluminal and open bypass interventions are compared not only with each other but also with a control group of patients with medical treatment only. DM
61%, p⫽0.27) and prior stroke (7.6% vs. 8.5%, p⫽0.54). The anticoagulation group was slightly younger than the group without (median, 76 vs. 78 years, p⫽0.006). Results: Operative mortality was 4.1% with 43 (3.7%) cerebrovascular events within 90 days. Excluding 18 deficits apparent upon emergence from anesthesia, postoperative cerebrovascular accident occurred in 2.4% of anticoagulated patients and 1.9% patients not anticoagulated. By multivariable analysis, the only predictor of operative mortality was hypertension (p⬍0.0001). Postoperative cerebrovascular accident was unrelated to warfarin use (p⫽0.32). The incidence of mediastinal bleeding requiring reexploration was similar (5.0% vs. 7.4%), as were other bleeding complications in the first 90 days (1.1% vs. 0.8%). No variables were predictive of bleeding by multivariate analysis. Conclusions: Although these data do not address the role of antiplatelet agents, early anticoagulation with warfarin after bioprosthetic aortic valve replacement did not appear to protect against neurologic events. Perspective: Although a subset of patients at increased risk of thromboembolic events probably should receive anticoagulation for 3 months, anticoagulation may not be necessary for all patients after bioprosthetic aortic valve replacement. Without additional data, use of antiplatelet agents is probably warranted. These data do not address bioprosthetic mitral valve replacement, which is associated with a higher thromboembolic risk. DB
Prediction of Early Cerebral Outcome by Transcranial Doppler Monitoring in Carotid Bifurcation Angioplasty and Stenting
Percutaneous and Open Renal Revascularizations Have Equivalent Long-Term Functional Outcomes Galaria II, Surowiec SM, Rhodes JM, et al. Ann Vasc Surg 2005;19:167–71.
Ackerstaff RGA, Suttorp MJ, van den Berg JC, et al. on behalf of the Antonius Carotid Endarterectomy, Angioplasty, and Stenting Study Group. J Vasc Surg 2005;41:618 –24.
Study Question: This study compares the anatomic and functional outcomes of open versus endovascular therapy for symptomatic atherosclerotic renal artery stenosis (RAS) in a clinically and demographically mixed patient population on a combined surgery/interventional radiology service at an academic medical center. Methods: The researchers performed a retrospective analysis of records from patients who underwent renal arterial interventions, endovascular or open bypass, between January 1984 and January 2004. Results: Principal indications for intervention were hypertension (51%), chronic renal insufficiency (13%), and hypertension and elevated creatinine (36%). A total of 247 patients (109 males; mean age 69⫾10, range 44 – 89 years) underwent 314 interventions (109 open procedures; 205 angioplasties, 71% with stent placement). There was a significant difference in 30-day mortality (4% vs. ⬍1%; p⬍0.005) between the open and endoluminal groups, but not at 1, 3 or 5 years. Patients in the open group had a higher primary patency rate at 5 years (83⫾5% vs. 76⫾6%; p⫽0.03), but patients in the endoluminal group had a higher assisted primary patency rate at 5 years (92⫾5% vs. 84⫾5; p⫽0.03). No significant differ-
Study Question: Investigators analyzed which transcranial Doppler (TCD)– detected emboli variables were associated with the occurrence of operative cerebral complications (transient and persistent) and death ⱕ7 days after the carotid angioplasty and stenting (CAS) procedure. Methods: The study was a prospective database of 550 patients undergoing CAS. The association of various TCD emboli and velocity variables with periprocedural cerebral outcome ⱕ7 days was evaluated by univariable and multivariable logistic regression analyses in combination with receiver operating characteristic (ROC) curve analyses. The impact of basic patient characteristics, such as age, gender, preprocedural cerebral symptoms, and ipsilateral carotid endarterectomy before CAS, was also evaluated. Results: The investigators observed 36 patients with amaurosis fugax (n⫽6; 1.1%) or transient ischemic attack (n⫽30; 5.4%), 1 patient (0.2%) with an ipsilateral retinal infarct, and 21 patients with minor (n⫽15; 2.7%) or major (n⫽6; 1.1%) stroke, respectively. Five patients (0.9%) died. Multiple showers of microemboli (⬎5) at postdilation after stent deployment (odds ratio [OR], 2.6; 95% confidence interval [CI], 1.3–5.1), particulate macroembolus (OR,
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Methods: Between 1991 and 2004, 332 patients between 45 and 65 years old with isolated aortic valve disease underwent valve replacement with a bioprosthesis. A stentless (Freestyle) valve was used in 140, homograft in 54, stented xenograft (Mosaic or Perimaount) in 62, and a Ross procedure in 76 patients. Results: Perioperative mortality was comparable for all groups (Freestyle, 2.1%; homograft, 3.7%; stented xenograft, 3.2%; Ross procedure, 1.3%; p⫽0.8). Echocardiographically determined hemodynamic performance at discharge was significantly better in the Ross procedure and homograft groups (indexed effective orifice area: Freestyle, 0.9⫾0.3 cm2/m2; homograft, 1.3⫾0.3 cm2/m2; stented xenograft, 0.8⫾0.2 cm2/m2; Ross procedure, 1.4⫾0.4; p⬍0.0001; mean gradient: Freestyle, 12.0⫾6.6 mm Hg; homograft, 7.4⫾4.0 mm Hg; stented xenograft, 15.4⫾5.4 mm Hg; Ross procedure, 4.6⫾3.2 mm Hg; p⬍0.0001). For all yearly follow-up, freedom from New York Heart Association class III or IV was comparable and ⬎95% for all groups. At 7 years, cardiac survival (homograft, 96.3⫾3.7%; Ross procedure, 90.6⫾6.3%; stented xenograft, 86.0⫾10.3%; Freestyle, 89.2⫾10.8%; p⫽0.7) and freedom from reoperation (Ross procedure, 98.5⫾1.4%; homograft, 90.6⫾5.7%; Freestyle, 88.0⫾4.9%; stented xenograft, 90.0⫾8.0%; p⫽0.4) were comparable. Freedom levels from significant bleeding events, valve-related neurologic events, and endocarditis were comparable and ⬎95% for all groups. Conclusions: Aortic bioprosthesis type does not affect midterm survival or valve-related morbidity for the 45- to 65-year-old patient. Perspective: Freedom from adverse events at only 7 years is not adequate to judge the relative benefits of a bioprosthesis in this age group, where 20- and 30-year outcomes (including durability) are of greater interest. Nevertheless, it is reassuring to know that these prostheses all perform well at this short-to-midterm follow-up. The paradox will remain of desiring long-term follow-up for devices that continue to evolve and improve. DB
Ix JH, Mercado N, Shlipak MG, et al. Am Heart J 2005;149:512–9. Study Question: What are the long-term clinical outcomes after coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI) with multivessel stenting in patients with chronic renal insufficiency (CRI)? Methods: The Arterial Revascularization Therapies Study (ARTS) randomly assigned 1205 participants with and without CRI either to CABG or PCI with multivessel stenting; CRI was defined as creatinine clearance ⱕ60 mL/min. The primary outcome was the composite end point of death, myocardial infarction (MI), or stroke; a secondary outcome was repeat revascularization. Participants were followed for a mean of 3 years after intervention. Results: At entry into ARTS, 290 patients (25%) had CRI; 151 underwent PCI, and 139 underwent CABG. No difference was observed between CABG or PCI in the primary end point (adjusted hazard ratio [HR] 0.93; 95% CI 0.54 – 1.60; p⫽0.97). However, CABG was associated with a reduced risk for repeat revascularization (HR 0.28; 95% CI 0.14 – 0.54; p⬍0.01). Compared with participants with normal renal function, CRI was associated with a nearly 2-fold risk for the primary outcome (unadjusted HR 1.9; 95% CI 1.4 –2.7; p⬍0.01), which remained significant on multivariate analysis (HR 1.6; 95% CI 1.1–2.4). Conclusions: In patients with multivessel CAD and CRI, treatment with CABG or PCI with multivessel stenting led to similar outcomes of death, MI, or stroke; but CABG was associated with decreased repeat revascularizations. When compared with ARTS participants with normal renal function, CRI was associated with a substantially elevated risk of adverse clinical outcomes after coronary revascularization. Perspective: Chronic renal insufficiency is associated with adverse cardiac outcomes in patients with coronary and valvular heart disease. Although preexisting renal insufficiency is associated with increased operative risk, these data suggest that outcomes are no worse than for percutaneous intervention. In an appropriate population, better freedom from revascularization may favor surgical revascularization in patients with CRI. DB
Is Early Anticoagulation With Warfarin Necessary After Bioprosthetic Aortic Valve Replacement? Sundt TM, Zehr KJ, Dearani JA, et al. J Thorac Cardiovasc Surg 2005;129:1024 –31. Study Question: Is anticoagulation with warfarin necessary for the first 3 months after bioprosthetic aortic valve replacement? Methods: Between 1993 and 2000, 1151 patients at a single institution underwent bioprosthetic aortic valve replacement with (641) or without (510) associated coronary artery bypass. By surgeon preference, 624 subjects had early postoperative anticoagulation and 527 did not. Of those not receiving early anticoagulation, 410 patients (78%) received antiplatelet therapy. Groups with and without early anticoagulation were similar with respect to gender (36% vs. 40% female, p⫽0.21), hypertension (64% vs.
Which Biologic Valve Should We Select for the 45to 65-Year-Old Age Group Requiring Aortic Valve Replacement? Dagenais F, Cartier P, Voisine P, et al. J Thorac Cardiovasc Surg 2005;129:1041–9. Study Question: Is there a preferable type of bioprosthesis for patients 45 to 65 years of age who require aortic valve replacement?
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ence existed between both treatment groups in cumulative freedom from presenting symptom or in freedom from dialysis and renal-related death. Patients who presented with hypertension were more likely to have shown improvement in their blood pressure with endoluminal intervention at 1, 3 and 5 years (59⫾6% endoluminal vs. 83⫾5% open; p⫽0.01). Conclusions: The investigators concluded that both open repair and endoluminal repair of atherosclerotic RAS have similar immediate and long-term functional and anatomic outcomes. Perspective: As reflected in this study, percutaneous intervention is becoming an increasingly popular treatment option for patients with symptoms from atherosclerotic RAS. When compared with open bypass, the procedure offers less morbidity and mortality and at least equivalent survival, primary-assisted patency rates, and functional outcomes. The endoluminal approach appears to be of even greater benefit to those patients with initial hypertension. To confirm the findings in this study and to prove that surgery or endoluminal intervention has a benefit over medical management alone, a prospective, randomized trial must be designed in which endoluminal and open bypass interventions are compared not only with each other but also with a control group of patients with medical treatment only. DM
61%, p⫽0.27) and prior stroke (7.6% vs. 8.5%, p⫽0.54). The anticoagulation group was slightly younger than the group without (median, 76 vs. 78 years, p⫽0.006). Results: Operative mortality was 4.1% with 43 (3.7%) cerebrovascular events within 90 days. Excluding 18 deficits apparent upon emergence from anesthesia, postoperative cerebrovascular accident occurred in 2.4% of anticoagulated patients and 1.9% patients not anticoagulated. By multivariable analysis, the only predictor of operative mortality was hypertension (p⬍0.0001). Postoperative cerebrovascular accident was unrelated to warfarin use (p⫽0.32). The incidence of mediastinal bleeding requiring reexploration was similar (5.0% vs. 7.4%), as were other bleeding complications in the first 90 days (1.1% vs. 0.8%). No variables were predictive of bleeding by multivariate analysis. Conclusions: Although these data do not address the role of antiplatelet agents, early anticoagulation with warfarin after bioprosthetic aortic valve replacement did not appear to protect against neurologic events. Perspective: Although a subset of patients at increased risk of thromboembolic events probably should receive anticoagulation for 3 months, anticoagulation may not be necessary for all patients after bioprosthetic aortic valve replacement. Without additional data, use of antiplatelet agents is probably warranted. These data do not address bioprosthetic mitral valve replacement, which is associated with a higher thromboembolic risk. DB
Prediction of Early Cerebral Outcome by Transcranial Doppler Monitoring in Carotid Bifurcation Angioplasty and Stenting
Percutaneous and Open Renal Revascularizations Have Equivalent Long-Term Functional Outcomes Galaria II, Surowiec SM, Rhodes JM, et al. Ann Vasc Surg 2005;19:167–71.
Ackerstaff RGA, Suttorp MJ, van den Berg JC, et al. on behalf of the Antonius Carotid Endarterectomy, Angioplasty, and Stenting Study Group. J Vasc Surg 2005;41:618 –24.
Study Question: This study compares the anatomic and functional outcomes of open versus endovascular therapy for symptomatic atherosclerotic renal artery stenosis (RAS) in a clinically and demographically mixed patient population on a combined surgery/interventional radiology service at an academic medical center. Methods: The researchers performed a retrospective analysis of records from patients who underwent renal arterial interventions, endovascular or open bypass, between January 1984 and January 2004. Results: Principal indications for intervention were hypertension (51%), chronic renal insufficiency (13%), and hypertension and elevated creatinine (36%). A total of 247 patients (109 males; mean age 69⫾10, range 44 – 89 years) underwent 314 interventions (109 open procedures; 205 angioplasties, 71% with stent placement). There was a significant difference in 30-day mortality (4% vs. ⬍1%; p⬍0.005) between the open and endoluminal groups, but not at 1, 3 or 5 years. Patients in the open group had a higher primary patency rate at 5 years (83⫾5% vs. 76⫾6%; p⫽0.03), but patients in the endoluminal group had a higher assisted primary patency rate at 5 years (92⫾5% vs. 84⫾5; p⫽0.03). No significant differ-
Study Question: Investigators analyzed which transcranial Doppler (TCD)– detected emboli variables were associated with the occurrence of operative cerebral complications (transient and persistent) and death ⱕ7 days after the carotid angioplasty and stenting (CAS) procedure. Methods: The study was a prospective database of 550 patients undergoing CAS. The association of various TCD emboli and velocity variables with periprocedural cerebral outcome ⱕ7 days was evaluated by univariable and multivariable logistic regression analyses in combination with receiver operating characteristic (ROC) curve analyses. The impact of basic patient characteristics, such as age, gender, preprocedural cerebral symptoms, and ipsilateral carotid endarterectomy before CAS, was also evaluated. Results: The investigators observed 36 patients with amaurosis fugax (n⫽6; 1.1%) or transient ischemic attack (n⫽30; 5.4%), 1 patient (0.2%) with an ipsilateral retinal infarct, and 21 patients with minor (n⫽15; 2.7%) or major (n⫽6; 1.1%) stroke, respectively. Five patients (0.9%) died. Multiple showers of microemboli (⬎5) at postdilation after stent deployment (odds ratio [OR], 2.6; 95% confidence interval [CI], 1.3–5.1), particulate macroembolus (OR,
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