Background: For patients with severe aortic stenosis and coronary artery disease, the completely ... more Background: For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach. Methods: The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in t...
The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. ... more The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0-10 days; 4.1% of strokes) and a late phase (11-365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (<21 kg/m(2)), and falls within the past 6 months. Significant procedural predictors were total time in the catheterizat...
Seminars in Cardiothoracic and Vascular Anesthesia, 1999
Several recent studies have shown that cardiac surgery poses significant risks for negative neuro... more Several recent studies have shown that cardiac surgery poses significant risks for negative neurologic and neu ropsychological outcome. Death and major stroke have become uncommon consequences of cardiac surgery, but more than two-thirds of the patients show evidence of neuropsychological dysfunction postoperatively. The mechanisms contributing to postcardiopulmonary bypass neuropsychological deficits are uncertain, and potentially there are many possible causative factors that may play a significant role in perioperative neuro logic injury. However, two major interrelated factors, hypoperfusion and emboli, are suggested as probable culprits. Perfusion is important because the level of global and focal cerebral blood flow during periods of high embolic risk will determine the amount of brain embolization as well as the localization of the lesions. Ultrasonically detected macroemboli have been re ported to be the best predictor of neurobehavioral outcome. Microemboli found in autopsy...
Study Objective. To assess the effects of a waiting period after clopidogrel treatment before cor... more Study Objective. To assess the effects of a waiting period after clopidogrel treatment before coronary artery bypass grafting (CABG). Design. Single-center, prospective, observational study. Setting. Cardiothoracic surgery intensive care unit at a university-affiliated medical center. Patients. One hundred consecutive patients who received clopidogrel and were scheduled to undergo primary CABG. In 64 of these patients, CABG was delayed at least 5 days after clopidogrel treatment (group A). The other 36 patients received clopidogrel treatment within 5 days of undergoing CABG (group B). Measurements and Main Results. Data were collected on patient demographics, time of last clopidogrel dose, preoperative anticoagulant and/or antiplatelet agents administered, surgical characteristics, intraoperative transfusions, blood products transfused, and chest tube output for 24 hours after surgery. No significant differences in baseline characteristics or intraoperative variables (number of bypasses, aortic crossclamp time, and cardiopulmonary bypass time) were noted between the two groups. Mean ± SD number of packed red blood cell units/patient was 1.1 ± 1.4 in group A versus 2.1 ± 2.5 in group B (p=0.009). Mean ± SD number of platelet units/patient transfused was 0.5 ± 0.9 in group A versus 1.9 ± 1.6 in group B (p<0.001). When comparing a subset of 21 patients who received clopidogrel within 72 hours of surgery with the 64 whose CABG was delayed at least 5 days after clopidogrel treatment, the transfusion rates were significantly higher (95% vs 52%, p<0.05). Specifically, the mean ± SD number of transfused units/patient of red blood cells (3.1 ± 2.8 vs 1.1 ± 1.4, p<0.005) and platelets (2.6 ± 1.5 vs 0.5 ± 0.9, p<0.007) was greater in patients who received clopidogrel within 72 hours of surgery. Conclusion. A strategy to delay CABG after clopidogrel treatment led to reduced blood product administration. The optimal waiting period after clopidogrel treatment is not known but appears to be at least 5 days before CABG.
The Journal of Thoracic and Cardiovascular Surgery, 2006
Objective: We hypothesized that a strategy that reduced aortic manipulation would reduce the inci... more Objective: We hypothesized that a strategy that reduced aortic manipulation would reduce the incidence of cognitive deficits in patients undergoing coronary artery bypass grafting compared with the "traditional" approach and that neurobehavioral outcomes with the reduced aortic manipulation strategy would approach those obtained with off-pump coronary artery bypass surgery. Methods: Consenting high-risk patients (those with older age, diabetes, or hypertension) scheduled for coronary artery bypass grafting and cardiopulmonary bypass were randomly assigned to 1 of 2 aortic management protocols: (1) a traditional approach in which distal anastomoses were accomplished while the aorta was crossclamped but in which proximal anastomoses were sewn while a partial occlusion clamp was applied to the aorta (multiple aortic clamping group) or (2) a reduced aortic manipulation approach in which the aorta was clamped a single time with a reduced-pressure clamp (single aortic clamping group) and the partial occlusion clamp was not used. A contemporaneous group of patients undergoing off-pump coronary artery bypass surgery without cardiopulmonary bypass was also enrolled. Subjects in all 3 groups underwent neurologic and neuropsychological testing before and after surgery. After randomization, patients assigned to either approach could be changed to another strategy if the attending surgeon determined that patient safety demanded this change. The study design anticipated that surgical techniques would evolve over the course of patient enrollment and anticipated that some patients would have intraoperative echocardiographic findings that would demand that the traditional approach (eg, severe aortic atherosclerosis) or the reduced manipulation protocol (eg, severe ischemia or poor left ventricular function) be abandoned. Thus, an unequal distribution of patients was expected. By surgeon decision, 20 of 84 multiple aortic clamping patients crossed over to single aortic clamping, and 3 of 85 single aortic clamping patients switched to multiple aortic clamping. Eligible patients had a battery of neuropsychological tests before surgery and at 6 months after surgery. A 20% decrement in 2 or more tests was defined as a neuropsychological deficit. Results: MAC OPCAB SAC Hospital mortality 3/67 (4%) 1/68 (1%) 0/102 (0%) Hospital stroke 3/67 (4%) 1/68 (1%) 3/102 (3%) Tested patients NPD 3-5 d 25/42 (60%) 33/47 (70%) 44/74 (60%) Tested patients NPD 3-6 wk 25/49 (51%) 20/51 (40%) 27/85 (32%) Tested patients NPD 6 mo 24/42 (57%) 13/41 (32%*) 22/74 (30%*) MAC, Multiple aortic clamping; OPCAB, off-pump coronary artery bypass; SAC, single aortic clamping; NPD, neuropsychological deficit. *P Ͻ .05 vs MAC. Conclusions: A surgical strategy designed to minimize aortic manipulation can significantly reduce the incidence of cognitive deficits in coronary artery bypass grafting patients compared with traditional techniques. In this series, the results of From the Departments of Cardiothoracic Surgery, a Anesthesiology, b and Radiology,
The Journal of Thoracic and Cardiovascular Surgery, 2005
Objective: Hyperglycemia worsens outcomes in critical illness. This randomized, double-blind, pla... more Objective: Hyperglycemia worsens outcomes in critical illness. This randomized, double-blind, placebo-controlled clinical trial tested whether insulin treatment of hyperglycemia during cardiopulmonary bypass would reduce neurologic, neuroophthalmologic, and neurobehavioral outcomes after coronary artery bypass grafting. Methods: Three hundred eighty-one nondiabetic patients undergoing isolated coronary artery bypass grafting were given infusions of insulin or placebo when their blood glucose concentration exceeded 100 mg/dL during cardiopulmonary bypass. The primary outcome measure was the combined incidence of new neurologic, neuro-ophthalmologic, or neurobehavioral deficits or neurologic death observed at 4 to 8 days postoperatively. This same measure was assessed secondarily at 6 weeks and 6 months. Length of hospital stay was also compared as a secondary assessment. Results: The 2 groups were well matched at baseline. The insulin-treated group had significantly lower blood glucose concentrations during bypass. Sixty-six percent of subjects in the insulin-treated group and 67% of subjects in the control group demonstrated a new or worsening neurologic, neuro-ophthalmologic, or neurobehavioral deficit or neurologic death at the 4-to 8-day assessment. Outcomes were also similar in the 2 groups at 6 weeks (37% and 39% incidence, respectively) and 6 months (30% and 25%, respectively). Median lengths of stay were 7 and 6 days, respectively, in the treatment and control groups. None of these outcome differences was statistically significant. Conclusion: Attempted control of hyperglycemia during cardiopulmonary bypass had no significant effect on the combined incidence of neurologic, neuro-ophthalmologic, or neurobehavioral deficits or neurologic death and failed to shorten the length of hospital stay. These results do not contradict those of other studies showing that aggressive control of hyperglycemia in the postoperative period will improve outcome.
Journal of Cardiothoracic and Vascular Anesthesia, 2002
To determine whether attempted glucose control through intraoperative insulin therapy reduces the... more To determine whether attempted glucose control through intraoperative insulin therapy reduces the need for inotropic or antiarrhythmic therapy after cardiopulmonary bypass (CPB). Design: Post hoc analysis of a randomized, masked clinical trial of insulin therapy for prevention of neurobehavioral deficits. Setting: Single university hospital. Participants: Nondiabetic patients undergoing elective coronary artery bypass graft surgery (n ؍ 381). Interventions: Patients received either insulin infusions in an attempt to maintain blood glucose at 80 to 120 mg/dL (n ؍ 188) or placebo (saline; n ؍ 193). Inotropic therapy was defined as the initiation of vasoactive support with epinephrine or amrinone infusions or mechanical support with the initiation of an intra-aortic balloon pump in the operating room or within 12 hours postoperatively. Antiarrhythmic therapy was defined as cardioversion, antiarrhythmic medications, or pacing. Measurements and Main Results: Of patients, 64 in the placebo group and 71 in the insulin group required inotropic support after CPB (p ؍ not significant). The use of cardioversion (55 in placebo group v 61 in insulin group), antiarrhythmic medications (64 in placebo group v 76 in insulin group), and pacing (118 in placebo group v 117 in insulin group) was similar between groups. Inotropic drug support was associated with age >60 years, female gender, reduced preoperative ejection fraction, history of angina, and increased duration of CPB. Conclusion: Intraoperative insulin therapy did not reduce the use of inotropic or antiarrhythmic support after cardiac surgery with CPB. The lack of benefit may be due to the inability to prevent hyperglycemia during the physiologic stress of CPB or a tribute to the effectiveness of modern myocardial preservation techniques.
Journal of Cardiothoracic and Vascular Anesthesia, 1992
To determine whether epinephrine might prove to be a tost-effective substitute for dobutamine, tw... more To determine whether epinephrine might prove to be a tost-effective substitute for dobutamine, two 8minute infusions of either epinephrine (10 and 30 ng/kg/min, n = 28) or dobutamine (2.5 and 5 pg/kg/min, n = 24) were administered to 52 patients recovering in the intensive care unit (ICU) after aortocoronary bypass (CABG) surgery. At the higher dose, both drugs significantly (P < .05) increased cardiac index (Cl), epinephrine from 2.8 f 0.1 at baseline to 3.3 f 0.1 L/min/m*, and dobutamine from 3.2 2 0.1 at baseline to 4.1-r 0.2 L/min/m*. Epinephrine increased Cl significantly less than dobutamine. Both drugs significantly increased stroke volume index (SVI), epinephrine from 32 2 1 at baseline to 36 & 1 mL/beat/m*, and dobutamine from 36 f 1 at baseline to 40 f 2 mL/ beat/ m*. At the higher dose, the effects of the two drugs on SVI were indistinguishable. On the other hand, while the higher dose of both drugs significantly increased heart rate (HR), epinephrine from 88 + 2 at baseline to 90 f 2 beats/min and dobutamine from 89 f 2 at baseline to 105 t 3 beats/min, the increase following the higher dose of dobutamine was significantly greater than METHODS Over a 2-year period, hemodynamic data were collected from 52 patients recovering in the intensive care unit (ICU) after CABG who were assigned to receive either epinephrine or dobutamine as part of a continuing study of inotropic agents in cardiac surgery patients.-?-l0 Subsequent analysis of these results allowed tests of the hypothesis that the effects of epinephrine and dobutamine were comparable. Al1 patients were scheduled for elective CABG and gave their preoperative informed consent. Al1 patients meeting that seen after epinephrine. Effects of the two drugs on mean arterial pressure, central venous pressure, pulmonary artery occlusion pressure, systemic vascular resistance, pulmonary vascular resistance, and left-ventricular stroke work did not significantly differ. Similar results were obtained in the subset of patients with baseline Cl less than 3 L/min/m* who more closely resembled patients who might acutely require inotropic drug administration. The wholesale tost of one ampule of dobutamine (250 mg) is more than 150 times that of epinephrine (1 mg). It is concluded that when SV was increased comparably by either epinephrine or dobutamine, epinephrine increased HR less than dobutamine. Thus, epinephrine may represent a tost-effective substitute for dobutamine, and its use may be associated with reduced tachycardia in the ICU after CABG.
Amrinone, a phosphodiesterase inhibitor, and epinephrine, an a-and P-adrenergic receptor agonist,... more Amrinone, a phosphodiesterase inhibitor, and epinephrine, an a-and P-adrenergic receptor agonist, are inotropic drugs used during cardiac surgery to reverse myocardial depression after cardiopulmonary bypass. However, these drugs have not been compared separately, or in combination, in this patient population. We hypothesized that the combination might have complementary actions in improving myocardial function. We, therefore, compared amrinone, epinephrine, and the combination of amrinone and epinephrine in a randomized, blinded, placebo-controlled study in patients undergoing coronary artery bypass grafting. Forty patients with ejection fractions >0.45 were studied. Right ventricular ejection fraction pulmonary artery catheters and radial arterial catheters were inserted before fentanyl-midazolam anesthesia. After separation from bypass, patients received either a placebo (n = 20) or amrinone bolus (1.5 mg/kg, n = 20) at time 0 and a placebo (n = 20) or epinephrine (30 ng.kg-'.rnin-', n = 20) infusion at time 5 min. This resulted in four study groups, n = 10 in each group. Data were collected every 2.5 min for 10 min. Epinephrine, amrinone, and the combination of both drugs significantly increased cardiac output, stroke volume, O2 delivery, and left ventricular stroke work. The increase in stroke volume This work was supported in part by a grant from Winthrop Phar
Background. In coronary artery bypass grafting (CABG) patients, neuropsychological deficits that ... more Background. In coronary artery bypass grafting (CABG) patients, neuropsychological deficits that are present from the time of the operation through 6 months postoperatively are considered permanent and represent organic brain damage related to the operation. We hypothesized that changes in our surgical method would reduce persistent deficits. Methods. From 1999 to 2004, consenting CABG patients were randomly assigned to multiple aortic cross-clamp or single aortic cross-clamp technique. An additional contemporary group of patients treated with off-pump CABG was studied. All patients underwent an 11-part neuropsychologic examination preoperatively, and at 1 week, 6 weeks, and 6 months postoperatively. One hundred seven patients with no postoperative neurologic deficits had neuropsychologic examinations at all four testing periods. Results. Off-pump CABG patients were significantly younger (60 ؎ 11 years) than multiple aortic cross-clamp (66 ؎ 8 years) and single aortic cross-clamp (64 ؎ 9 years; p < 0.05) patients. At 6 months, 26% of 27 multiple aortic cross-clamp patients had neuropsychological deficits, 27% of 26 off-pump CABG patients had neuropsychological deficits, and only 9% of 54 single aortic cross-clamp patients had neuropsychological deficits (p ؍ 0.067 versus multiple aortic cross-clamp and off-pump CABG). Conclusions. These results suggest that surgical technique is very important in determining cognitive outcome after CABG. Cardiopulmonary bypass is not the most important factor in determining outcome and when carefully performed with single cross-clamp and minimal aortic manipulation is equal or may be superior to off-pump operation. We suspect that mild hypothermia in on-pump surgery is additionally neuroprotective, a factor that should be taken into account when planning an operation.
Background: Glycoprotein (GP) IIb/IIIa antagonists are used routinely for the treatment of acute ... more Background: Glycoprotein (GP) IIb/IIIa antagonists are used routinely for the treatment of acute coronary syndrome and to prevent thromboses during percutaneous coronary interventions. It is not uncommon for patients who initially require a GP IIb/IIIa inhibitor to eventually receive a surgical intervention. Objective: To compare the difference in bleeding indices in patients who undergo coronary artery bypass grafting (CABG) after receiving either eptifibatide or abciximab. Methods: A retrospective chart review was completed on all adults who received abciximab or eptifibatide within 24 hours prior to undergoing CABG. Patients were excluded if they had received a dose of warfarin within 96 hours prior to the procedure or if they had an incomplete medical record, an off-pump procedure, a known hypercoagulable disorder, or hemophilia. A total of 54 patients were included and preoperative data, including doses of anticoagulant and antiplatelet agents, were recorded. Intraoperative and postoperative data collected for analysis included hemoglobin level, chest tube output, and the amount of blood products transfused for 24 hours postprocedure. Results: There was a statistically significant difference between the eptifibatide and abciximab groups in the amount of fresh frozen plasma (mean ± SD, 21 ± 31 vs 187 ± 125 mL, respectively; p < 0.05) and platelets (212 ± 81 vs 433 ± 118 mL, respectively; p < 0.01) transfused during the intraoperative period. However, when the total amount of blood products transfused intraoperatively (769 ± 243 vs 1395 ± 316 mL, respectively; p = 0.47) was evaluated, no significant difference was detected. Likewise, markers for bleeding that were collected during the 24-hour postoperative window (immediate and 24-h postoperative hemoglobin and total 24-h chest tube output) were not significantly different. Conclusions: Although there is an increased risk of bleeding when abciximab or eptifibatide is administered prior to CABG, no significant difference in the total amount of blood products used was detected between the 2 agents in this study.
Background. Stentless aortic bioprostheses have excellent hemodynamics and clinical outcomes. The... more Background. Stentless aortic bioprostheses have excellent hemodynamics and clinical outcomes. The purpose of the present study was to determine whether implant technique of the Freestyle aortic root bioprosthesis impacts clinical outcomes or hemodynamic performance. Methods. The long-term multicenter study of the Freestyle stentless aortic bioprosthesis includes 500 consecutive patients implanted using the subcoronary and 162 using the full root technique. Clinical outcomes and echocardiographic hemodynamics were compared through 5 years. Results. There were no differences between groups in time to death, valve-related death, or reoperation. The incidence of operative death was higher in the full root than in the subcoronary group (odds ratio 3.97, p ؍ 0.001). Patients in the subcoronary group were more likely to have New York Heart Association functional class III or IV symptoms at 1 year (1.7% versus 0%, p ؍ 0.04) and 5 years postoperatively (4.4% versus 0%, p ؍ 0.02). Mean gradient was lower (p ؍ 0.0004) and effective orifice area larger (p ؍ 0.04) in the full root group. Left ventricular mass index decreased in both groups. The preponderance of patients in both groups had no or trivial aortic regurgitation through 5 years. Conclusions. Full root implantation of the Freestyle stentless aortic bioprosthesis was associated with higher operative mortality, but somewhat better hemodynamics, functional class, and freedom from aortic regurgitation. Higher operative mortality argues against the empiric replacement of the ascending aorta in the absence of aortic root pathology. In appropriately selected patients, both implant techniques are viable alternatives for valve implantation.
Lessons learned from the characterization of the biological roles of Ang-(1-7) [angiotensin-(1-7)... more Lessons learned from the characterization of the biological roles of Ang-(1-7) [angiotensin-(1-7)] in opposing the vasoconstrictor, proliferative and prothrombotic actions of AngII (angiotensin II) created an underpinning for a more comprehensive exploration of the multiple pathways by which the RAS (renin-angiotensin system) of blood and tissues regulates homoeostasis and its altered state in disease processes. The present review summarizes the progress that has been made in the novel exploration of intermediate shorter forms of angiotensinogen through the characterization of the expression and functions of the dodecapeptide Ang-(1-12) [angiotensin-(1-12)] in the cardiac production of AngII. The studies reveal significant differences in humans compared with rodents regarding the enzymatic pathway by which Ang-(1-12) undergoes metabolism. Highlights of the research include the demonstration of chymase-directed formation of AngII from Ang-(1-12) in human left atrial myocytes and left...
An article by Edwards and colleagues [1] reported an unfavorable experience with the Omniscience ... more An article by Edwards and colleagues [1] reported an unfavorable experience with the Omniscience mechanical valve, the previous cardiac valve model of MedicalCV, Inc. MedicalCV, Inc, is concerned about unjustifiably alarming patients worldwide with the Omniscience valve (about 50,000 implants) and considers itself obliged to comment on complications reported in this article. However, it is handicapped by a lack of pertinent information from the authors, despite repeated requests and regulatory requirements. The reported high rates of thromboembolism and hemorrhage contrast with several other studies, some of which the authors cited. Edwards and co-workers described inadequate anticoagulation in at least 50% of patients with valve thrombosis and 30% of those with thromboembolism and overanticoagulation in 38% of patients with hemorrhage, findings indicating poor patient compliance, inadequate therapy management, or both. These are precursors of poor results, regardless of valve model. It would have been useful, therefore, to compare the reported complication rates with the same center's contemporary experience with other mechanical valves; a search of the literature revealed no such publications. Seventeen patients were in the non-guideline complication category "limited disc excursion," although the auther did not provide disc opening measurements and methodology. Cardiac valves are passive devices; a disc opens to the degree demanded by cardiac stroke volume. Three explanted valves were returned to MedicalCV for evaluation (Ͼ11 years ago). All patients had chronic atrial fibrillation, one had a paravalvular leak, and two had undergone prior valve replacement. Therefore, limited disc excursion could be the effect of atrial fibrillation or a poor ventricle-rather than the cause. Exacerbating these poor ventricular conditions was the high number of patients who had had a previous valve operation (24.5%). Limited disc excursion could also be caused by myocardial interference with mitral disc motion as a result of ventricular size regression. In this regard, the authors did not indicate their preference regarding valve sizing, posterior leaflet preservation, or valve orientation. Company records show the mean mitral valve size selected by Edwards and associates was 29.6 mm, and this reveals a tendency toward oversizing. At the inception of Doppler echocardiography, the phenomenon of gradient "overestimation" was not commonly recognized. MedicalCV is aware of a case at this institution where cardiologists urged reoperation because of high gradients at echocardiography. At reoperation, the Omniscience aortic valve exhibited a low pressure gradient by manometric measurement, and the surgeon elected not to replace the prosthesis. Contrary to statements in the article, two explants evaluated by the Georgia Institute of Technology demonstrated no structural or functional abnormalities. Subsequent examination at MedicalCV's laboratories confirmed these findings. Qualitative examination of the wear track indicated occasional partial opening in vivo, probably caused by the patients' atrial fibrillation. Space limitations prevent detailing the divergent references and the numerous statistical deficiencies in this article. For instance, the number of patients is smaller than reported to MedicalCV with implantation cards, there were either 20 or 22 patients having multiple-valve replacement (Table 1), and even the implantation period does not match what is shown in the company's verifiable records.
Objectives: We sought to describe the hemodynamic and clinical outcomes for the Freestyle aortic ... more Objectives: We sought to describe the hemodynamic and clinical outcomes for the Freestyle aortic root bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in a large multicenter cohort prospectively followed for 8 years. Methods: A total of 700 patients (651 [93%] Ͼ60 years of age) at 8 centers in North America were followed prospectively after aortic valve replacement with the Freestyle stentless bioprosthesis; the implant technique was subcoronary in 500, total root in 162, and root inclusion in 38. Follow-up was 3395 patient-years (4.9 Ϯ 2.3 years per patient). Clinical and echocardiographic follow-up was prospectively obtained at yearly intervals. Results: For the subcoronary, total root, and root inclusion groups, actuarial freedom from valve-related death was 96.8% (SE 3.0%), 92.3% (SE 7.7%), and 90.9% (SE 11.2%), respectively, and freedom from structural deterioration was 98.6% (SE 2.0%), 100.0% (SE 0.0%), and 100.0% (SE 0.0%), respectively. Hemodynamics remained excellent at 6 years. Freedom from moderate or more aortic regurgitation was 86.0% (SE 5.1%), 98.7% (SE 3.9%), and 97.3% (SE 6.6%), respectively. Gradients were slightly lower (P ϭ .0009), and the effective orifice area (P ϭ .02) and freedom from aortic regurgitation were slightly higher (P ϭ .03) with total root than subcoronary implantation. Conclusions: The Freestyle stentless aortic root bioprosthesis is a versatile option for aortic valve replacement. Measures of clinical outcomes and prosthesis durability remain excellent in multicenter follow-up through 8 years in a population predominantly older than 60 years at the time of the operation.
Background: For patients with severe aortic stenosis and coronary artery disease, the completely ... more Background: For patients with severe aortic stenosis and coronary artery disease, the completely percutaneous approach to aortic valve replacement and revascularization has not been compared with the standard surgical approach. Methods: The prospective SURTAVI trial (Safety and Efficiency Study of the Medtronic CoreValve System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement) enrolled intermediate-risk patients with severe aortic stenosis from 87 centers in the United States, Canada, and Europe between June 2012 and June 2016. Complex coronary artery disease with SYNTAX score (Synergy Between PCI with Taxus and Cardiac Surgery Trial) >22 was an exclusion criterion. Patients were stratified according to the need for revascularization and then randomly assigned to treatment with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Patients assigned to revascularization in t...
The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. ... more The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0-10 days; 4.1% of strokes) and a late phase (11-365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (<21 kg/m(2)), and falls within the past 6 months. Significant procedural predictors were total time in the catheterizat...
Seminars in Cardiothoracic and Vascular Anesthesia, 1999
Several recent studies have shown that cardiac surgery poses significant risks for negative neuro... more Several recent studies have shown that cardiac surgery poses significant risks for negative neurologic and neu ropsychological outcome. Death and major stroke have become uncommon consequences of cardiac surgery, but more than two-thirds of the patients show evidence of neuropsychological dysfunction postoperatively. The mechanisms contributing to postcardiopulmonary bypass neuropsychological deficits are uncertain, and potentially there are many possible causative factors that may play a significant role in perioperative neuro logic injury. However, two major interrelated factors, hypoperfusion and emboli, are suggested as probable culprits. Perfusion is important because the level of global and focal cerebral blood flow during periods of high embolic risk will determine the amount of brain embolization as well as the localization of the lesions. Ultrasonically detected macroemboli have been re ported to be the best predictor of neurobehavioral outcome. Microemboli found in autopsy...
Study Objective. To assess the effects of a waiting period after clopidogrel treatment before cor... more Study Objective. To assess the effects of a waiting period after clopidogrel treatment before coronary artery bypass grafting (CABG). Design. Single-center, prospective, observational study. Setting. Cardiothoracic surgery intensive care unit at a university-affiliated medical center. Patients. One hundred consecutive patients who received clopidogrel and were scheduled to undergo primary CABG. In 64 of these patients, CABG was delayed at least 5 days after clopidogrel treatment (group A). The other 36 patients received clopidogrel treatment within 5 days of undergoing CABG (group B). Measurements and Main Results. Data were collected on patient demographics, time of last clopidogrel dose, preoperative anticoagulant and/or antiplatelet agents administered, surgical characteristics, intraoperative transfusions, blood products transfused, and chest tube output for 24 hours after surgery. No significant differences in baseline characteristics or intraoperative variables (number of bypasses, aortic crossclamp time, and cardiopulmonary bypass time) were noted between the two groups. Mean ± SD number of packed red blood cell units/patient was 1.1 ± 1.4 in group A versus 2.1 ± 2.5 in group B (p=0.009). Mean ± SD number of platelet units/patient transfused was 0.5 ± 0.9 in group A versus 1.9 ± 1.6 in group B (p<0.001). When comparing a subset of 21 patients who received clopidogrel within 72 hours of surgery with the 64 whose CABG was delayed at least 5 days after clopidogrel treatment, the transfusion rates were significantly higher (95% vs 52%, p<0.05). Specifically, the mean ± SD number of transfused units/patient of red blood cells (3.1 ± 2.8 vs 1.1 ± 1.4, p<0.005) and platelets (2.6 ± 1.5 vs 0.5 ± 0.9, p<0.007) was greater in patients who received clopidogrel within 72 hours of surgery. Conclusion. A strategy to delay CABG after clopidogrel treatment led to reduced blood product administration. The optimal waiting period after clopidogrel treatment is not known but appears to be at least 5 days before CABG.
The Journal of Thoracic and Cardiovascular Surgery, 2006
Objective: We hypothesized that a strategy that reduced aortic manipulation would reduce the inci... more Objective: We hypothesized that a strategy that reduced aortic manipulation would reduce the incidence of cognitive deficits in patients undergoing coronary artery bypass grafting compared with the "traditional" approach and that neurobehavioral outcomes with the reduced aortic manipulation strategy would approach those obtained with off-pump coronary artery bypass surgery. Methods: Consenting high-risk patients (those with older age, diabetes, or hypertension) scheduled for coronary artery bypass grafting and cardiopulmonary bypass were randomly assigned to 1 of 2 aortic management protocols: (1) a traditional approach in which distal anastomoses were accomplished while the aorta was crossclamped but in which proximal anastomoses were sewn while a partial occlusion clamp was applied to the aorta (multiple aortic clamping group) or (2) a reduced aortic manipulation approach in which the aorta was clamped a single time with a reduced-pressure clamp (single aortic clamping group) and the partial occlusion clamp was not used. A contemporaneous group of patients undergoing off-pump coronary artery bypass surgery without cardiopulmonary bypass was also enrolled. Subjects in all 3 groups underwent neurologic and neuropsychological testing before and after surgery. After randomization, patients assigned to either approach could be changed to another strategy if the attending surgeon determined that patient safety demanded this change. The study design anticipated that surgical techniques would evolve over the course of patient enrollment and anticipated that some patients would have intraoperative echocardiographic findings that would demand that the traditional approach (eg, severe aortic atherosclerosis) or the reduced manipulation protocol (eg, severe ischemia or poor left ventricular function) be abandoned. Thus, an unequal distribution of patients was expected. By surgeon decision, 20 of 84 multiple aortic clamping patients crossed over to single aortic clamping, and 3 of 85 single aortic clamping patients switched to multiple aortic clamping. Eligible patients had a battery of neuropsychological tests before surgery and at 6 months after surgery. A 20% decrement in 2 or more tests was defined as a neuropsychological deficit. Results: MAC OPCAB SAC Hospital mortality 3/67 (4%) 1/68 (1%) 0/102 (0%) Hospital stroke 3/67 (4%) 1/68 (1%) 3/102 (3%) Tested patients NPD 3-5 d 25/42 (60%) 33/47 (70%) 44/74 (60%) Tested patients NPD 3-6 wk 25/49 (51%) 20/51 (40%) 27/85 (32%) Tested patients NPD 6 mo 24/42 (57%) 13/41 (32%*) 22/74 (30%*) MAC, Multiple aortic clamping; OPCAB, off-pump coronary artery bypass; SAC, single aortic clamping; NPD, neuropsychological deficit. *P Ͻ .05 vs MAC. Conclusions: A surgical strategy designed to minimize aortic manipulation can significantly reduce the incidence of cognitive deficits in coronary artery bypass grafting patients compared with traditional techniques. In this series, the results of From the Departments of Cardiothoracic Surgery, a Anesthesiology, b and Radiology,
The Journal of Thoracic and Cardiovascular Surgery, 2005
Objective: Hyperglycemia worsens outcomes in critical illness. This randomized, double-blind, pla... more Objective: Hyperglycemia worsens outcomes in critical illness. This randomized, double-blind, placebo-controlled clinical trial tested whether insulin treatment of hyperglycemia during cardiopulmonary bypass would reduce neurologic, neuroophthalmologic, and neurobehavioral outcomes after coronary artery bypass grafting. Methods: Three hundred eighty-one nondiabetic patients undergoing isolated coronary artery bypass grafting were given infusions of insulin or placebo when their blood glucose concentration exceeded 100 mg/dL during cardiopulmonary bypass. The primary outcome measure was the combined incidence of new neurologic, neuro-ophthalmologic, or neurobehavioral deficits or neurologic death observed at 4 to 8 days postoperatively. This same measure was assessed secondarily at 6 weeks and 6 months. Length of hospital stay was also compared as a secondary assessment. Results: The 2 groups were well matched at baseline. The insulin-treated group had significantly lower blood glucose concentrations during bypass. Sixty-six percent of subjects in the insulin-treated group and 67% of subjects in the control group demonstrated a new or worsening neurologic, neuro-ophthalmologic, or neurobehavioral deficit or neurologic death at the 4-to 8-day assessment. Outcomes were also similar in the 2 groups at 6 weeks (37% and 39% incidence, respectively) and 6 months (30% and 25%, respectively). Median lengths of stay were 7 and 6 days, respectively, in the treatment and control groups. None of these outcome differences was statistically significant. Conclusion: Attempted control of hyperglycemia during cardiopulmonary bypass had no significant effect on the combined incidence of neurologic, neuro-ophthalmologic, or neurobehavioral deficits or neurologic death and failed to shorten the length of hospital stay. These results do not contradict those of other studies showing that aggressive control of hyperglycemia in the postoperative period will improve outcome.
Journal of Cardiothoracic and Vascular Anesthesia, 2002
To determine whether attempted glucose control through intraoperative insulin therapy reduces the... more To determine whether attempted glucose control through intraoperative insulin therapy reduces the need for inotropic or antiarrhythmic therapy after cardiopulmonary bypass (CPB). Design: Post hoc analysis of a randomized, masked clinical trial of insulin therapy for prevention of neurobehavioral deficits. Setting: Single university hospital. Participants: Nondiabetic patients undergoing elective coronary artery bypass graft surgery (n ؍ 381). Interventions: Patients received either insulin infusions in an attempt to maintain blood glucose at 80 to 120 mg/dL (n ؍ 188) or placebo (saline; n ؍ 193). Inotropic therapy was defined as the initiation of vasoactive support with epinephrine or amrinone infusions or mechanical support with the initiation of an intra-aortic balloon pump in the operating room or within 12 hours postoperatively. Antiarrhythmic therapy was defined as cardioversion, antiarrhythmic medications, or pacing. Measurements and Main Results: Of patients, 64 in the placebo group and 71 in the insulin group required inotropic support after CPB (p ؍ not significant). The use of cardioversion (55 in placebo group v 61 in insulin group), antiarrhythmic medications (64 in placebo group v 76 in insulin group), and pacing (118 in placebo group v 117 in insulin group) was similar between groups. Inotropic drug support was associated with age >60 years, female gender, reduced preoperative ejection fraction, history of angina, and increased duration of CPB. Conclusion: Intraoperative insulin therapy did not reduce the use of inotropic or antiarrhythmic support after cardiac surgery with CPB. The lack of benefit may be due to the inability to prevent hyperglycemia during the physiologic stress of CPB or a tribute to the effectiveness of modern myocardial preservation techniques.
Journal of Cardiothoracic and Vascular Anesthesia, 1992
To determine whether epinephrine might prove to be a tost-effective substitute for dobutamine, tw... more To determine whether epinephrine might prove to be a tost-effective substitute for dobutamine, two 8minute infusions of either epinephrine (10 and 30 ng/kg/min, n = 28) or dobutamine (2.5 and 5 pg/kg/min, n = 24) were administered to 52 patients recovering in the intensive care unit (ICU) after aortocoronary bypass (CABG) surgery. At the higher dose, both drugs significantly (P < .05) increased cardiac index (Cl), epinephrine from 2.8 f 0.1 at baseline to 3.3 f 0.1 L/min/m*, and dobutamine from 3.2 2 0.1 at baseline to 4.1-r 0.2 L/min/m*. Epinephrine increased Cl significantly less than dobutamine. Both drugs significantly increased stroke volume index (SVI), epinephrine from 32 2 1 at baseline to 36 & 1 mL/beat/m*, and dobutamine from 36 f 1 at baseline to 40 f 2 mL/ beat/ m*. At the higher dose, the effects of the two drugs on SVI were indistinguishable. On the other hand, while the higher dose of both drugs significantly increased heart rate (HR), epinephrine from 88 + 2 at baseline to 90 f 2 beats/min and dobutamine from 89 f 2 at baseline to 105 t 3 beats/min, the increase following the higher dose of dobutamine was significantly greater than METHODS Over a 2-year period, hemodynamic data were collected from 52 patients recovering in the intensive care unit (ICU) after CABG who were assigned to receive either epinephrine or dobutamine as part of a continuing study of inotropic agents in cardiac surgery patients.-?-l0 Subsequent analysis of these results allowed tests of the hypothesis that the effects of epinephrine and dobutamine were comparable. Al1 patients were scheduled for elective CABG and gave their preoperative informed consent. Al1 patients meeting that seen after epinephrine. Effects of the two drugs on mean arterial pressure, central venous pressure, pulmonary artery occlusion pressure, systemic vascular resistance, pulmonary vascular resistance, and left-ventricular stroke work did not significantly differ. Similar results were obtained in the subset of patients with baseline Cl less than 3 L/min/m* who more closely resembled patients who might acutely require inotropic drug administration. The wholesale tost of one ampule of dobutamine (250 mg) is more than 150 times that of epinephrine (1 mg). It is concluded that when SV was increased comparably by either epinephrine or dobutamine, epinephrine increased HR less than dobutamine. Thus, epinephrine may represent a tost-effective substitute for dobutamine, and its use may be associated with reduced tachycardia in the ICU after CABG.
Amrinone, a phosphodiesterase inhibitor, and epinephrine, an a-and P-adrenergic receptor agonist,... more Amrinone, a phosphodiesterase inhibitor, and epinephrine, an a-and P-adrenergic receptor agonist, are inotropic drugs used during cardiac surgery to reverse myocardial depression after cardiopulmonary bypass. However, these drugs have not been compared separately, or in combination, in this patient population. We hypothesized that the combination might have complementary actions in improving myocardial function. We, therefore, compared amrinone, epinephrine, and the combination of amrinone and epinephrine in a randomized, blinded, placebo-controlled study in patients undergoing coronary artery bypass grafting. Forty patients with ejection fractions >0.45 were studied. Right ventricular ejection fraction pulmonary artery catheters and radial arterial catheters were inserted before fentanyl-midazolam anesthesia. After separation from bypass, patients received either a placebo (n = 20) or amrinone bolus (1.5 mg/kg, n = 20) at time 0 and a placebo (n = 20) or epinephrine (30 ng.kg-'.rnin-', n = 20) infusion at time 5 min. This resulted in four study groups, n = 10 in each group. Data were collected every 2.5 min for 10 min. Epinephrine, amrinone, and the combination of both drugs significantly increased cardiac output, stroke volume, O2 delivery, and left ventricular stroke work. The increase in stroke volume This work was supported in part by a grant from Winthrop Phar
Background. In coronary artery bypass grafting (CABG) patients, neuropsychological deficits that ... more Background. In coronary artery bypass grafting (CABG) patients, neuropsychological deficits that are present from the time of the operation through 6 months postoperatively are considered permanent and represent organic brain damage related to the operation. We hypothesized that changes in our surgical method would reduce persistent deficits. Methods. From 1999 to 2004, consenting CABG patients were randomly assigned to multiple aortic cross-clamp or single aortic cross-clamp technique. An additional contemporary group of patients treated with off-pump CABG was studied. All patients underwent an 11-part neuropsychologic examination preoperatively, and at 1 week, 6 weeks, and 6 months postoperatively. One hundred seven patients with no postoperative neurologic deficits had neuropsychologic examinations at all four testing periods. Results. Off-pump CABG patients were significantly younger (60 ؎ 11 years) than multiple aortic cross-clamp (66 ؎ 8 years) and single aortic cross-clamp (64 ؎ 9 years; p < 0.05) patients. At 6 months, 26% of 27 multiple aortic cross-clamp patients had neuropsychological deficits, 27% of 26 off-pump CABG patients had neuropsychological deficits, and only 9% of 54 single aortic cross-clamp patients had neuropsychological deficits (p ؍ 0.067 versus multiple aortic cross-clamp and off-pump CABG). Conclusions. These results suggest that surgical technique is very important in determining cognitive outcome after CABG. Cardiopulmonary bypass is not the most important factor in determining outcome and when carefully performed with single cross-clamp and minimal aortic manipulation is equal or may be superior to off-pump operation. We suspect that mild hypothermia in on-pump surgery is additionally neuroprotective, a factor that should be taken into account when planning an operation.
Background: Glycoprotein (GP) IIb/IIIa antagonists are used routinely for the treatment of acute ... more Background: Glycoprotein (GP) IIb/IIIa antagonists are used routinely for the treatment of acute coronary syndrome and to prevent thromboses during percutaneous coronary interventions. It is not uncommon for patients who initially require a GP IIb/IIIa inhibitor to eventually receive a surgical intervention. Objective: To compare the difference in bleeding indices in patients who undergo coronary artery bypass grafting (CABG) after receiving either eptifibatide or abciximab. Methods: A retrospective chart review was completed on all adults who received abciximab or eptifibatide within 24 hours prior to undergoing CABG. Patients were excluded if they had received a dose of warfarin within 96 hours prior to the procedure or if they had an incomplete medical record, an off-pump procedure, a known hypercoagulable disorder, or hemophilia. A total of 54 patients were included and preoperative data, including doses of anticoagulant and antiplatelet agents, were recorded. Intraoperative and postoperative data collected for analysis included hemoglobin level, chest tube output, and the amount of blood products transfused for 24 hours postprocedure. Results: There was a statistically significant difference between the eptifibatide and abciximab groups in the amount of fresh frozen plasma (mean ± SD, 21 ± 31 vs 187 ± 125 mL, respectively; p < 0.05) and platelets (212 ± 81 vs 433 ± 118 mL, respectively; p < 0.01) transfused during the intraoperative period. However, when the total amount of blood products transfused intraoperatively (769 ± 243 vs 1395 ± 316 mL, respectively; p = 0.47) was evaluated, no significant difference was detected. Likewise, markers for bleeding that were collected during the 24-hour postoperative window (immediate and 24-h postoperative hemoglobin and total 24-h chest tube output) were not significantly different. Conclusions: Although there is an increased risk of bleeding when abciximab or eptifibatide is administered prior to CABG, no significant difference in the total amount of blood products used was detected between the 2 agents in this study.
Background. Stentless aortic bioprostheses have excellent hemodynamics and clinical outcomes. The... more Background. Stentless aortic bioprostheses have excellent hemodynamics and clinical outcomes. The purpose of the present study was to determine whether implant technique of the Freestyle aortic root bioprosthesis impacts clinical outcomes or hemodynamic performance. Methods. The long-term multicenter study of the Freestyle stentless aortic bioprosthesis includes 500 consecutive patients implanted using the subcoronary and 162 using the full root technique. Clinical outcomes and echocardiographic hemodynamics were compared through 5 years. Results. There were no differences between groups in time to death, valve-related death, or reoperation. The incidence of operative death was higher in the full root than in the subcoronary group (odds ratio 3.97, p ؍ 0.001). Patients in the subcoronary group were more likely to have New York Heart Association functional class III or IV symptoms at 1 year (1.7% versus 0%, p ؍ 0.04) and 5 years postoperatively (4.4% versus 0%, p ؍ 0.02). Mean gradient was lower (p ؍ 0.0004) and effective orifice area larger (p ؍ 0.04) in the full root group. Left ventricular mass index decreased in both groups. The preponderance of patients in both groups had no or trivial aortic regurgitation through 5 years. Conclusions. Full root implantation of the Freestyle stentless aortic bioprosthesis was associated with higher operative mortality, but somewhat better hemodynamics, functional class, and freedom from aortic regurgitation. Higher operative mortality argues against the empiric replacement of the ascending aorta in the absence of aortic root pathology. In appropriately selected patients, both implant techniques are viable alternatives for valve implantation.
Lessons learned from the characterization of the biological roles of Ang-(1-7) [angiotensin-(1-7)... more Lessons learned from the characterization of the biological roles of Ang-(1-7) [angiotensin-(1-7)] in opposing the vasoconstrictor, proliferative and prothrombotic actions of AngII (angiotensin II) created an underpinning for a more comprehensive exploration of the multiple pathways by which the RAS (renin-angiotensin system) of blood and tissues regulates homoeostasis and its altered state in disease processes. The present review summarizes the progress that has been made in the novel exploration of intermediate shorter forms of angiotensinogen through the characterization of the expression and functions of the dodecapeptide Ang-(1-12) [angiotensin-(1-12)] in the cardiac production of AngII. The studies reveal significant differences in humans compared with rodents regarding the enzymatic pathway by which Ang-(1-12) undergoes metabolism. Highlights of the research include the demonstration of chymase-directed formation of AngII from Ang-(1-12) in human left atrial myocytes and left...
An article by Edwards and colleagues [1] reported an unfavorable experience with the Omniscience ... more An article by Edwards and colleagues [1] reported an unfavorable experience with the Omniscience mechanical valve, the previous cardiac valve model of MedicalCV, Inc. MedicalCV, Inc, is concerned about unjustifiably alarming patients worldwide with the Omniscience valve (about 50,000 implants) and considers itself obliged to comment on complications reported in this article. However, it is handicapped by a lack of pertinent information from the authors, despite repeated requests and regulatory requirements. The reported high rates of thromboembolism and hemorrhage contrast with several other studies, some of which the authors cited. Edwards and co-workers described inadequate anticoagulation in at least 50% of patients with valve thrombosis and 30% of those with thromboembolism and overanticoagulation in 38% of patients with hemorrhage, findings indicating poor patient compliance, inadequate therapy management, or both. These are precursors of poor results, regardless of valve model. It would have been useful, therefore, to compare the reported complication rates with the same center's contemporary experience with other mechanical valves; a search of the literature revealed no such publications. Seventeen patients were in the non-guideline complication category "limited disc excursion," although the auther did not provide disc opening measurements and methodology. Cardiac valves are passive devices; a disc opens to the degree demanded by cardiac stroke volume. Three explanted valves were returned to MedicalCV for evaluation (Ͼ11 years ago). All patients had chronic atrial fibrillation, one had a paravalvular leak, and two had undergone prior valve replacement. Therefore, limited disc excursion could be the effect of atrial fibrillation or a poor ventricle-rather than the cause. Exacerbating these poor ventricular conditions was the high number of patients who had had a previous valve operation (24.5%). Limited disc excursion could also be caused by myocardial interference with mitral disc motion as a result of ventricular size regression. In this regard, the authors did not indicate their preference regarding valve sizing, posterior leaflet preservation, or valve orientation. Company records show the mean mitral valve size selected by Edwards and associates was 29.6 mm, and this reveals a tendency toward oversizing. At the inception of Doppler echocardiography, the phenomenon of gradient "overestimation" was not commonly recognized. MedicalCV is aware of a case at this institution where cardiologists urged reoperation because of high gradients at echocardiography. At reoperation, the Omniscience aortic valve exhibited a low pressure gradient by manometric measurement, and the surgeon elected not to replace the prosthesis. Contrary to statements in the article, two explants evaluated by the Georgia Institute of Technology demonstrated no structural or functional abnormalities. Subsequent examination at MedicalCV's laboratories confirmed these findings. Qualitative examination of the wear track indicated occasional partial opening in vivo, probably caused by the patients' atrial fibrillation. Space limitations prevent detailing the divergent references and the numerous statistical deficiencies in this article. For instance, the number of patients is smaller than reported to MedicalCV with implantation cards, there were either 20 or 22 patients having multiple-valve replacement (Table 1), and even the implantation period does not match what is shown in the company's verifiable records.
Objectives: We sought to describe the hemodynamic and clinical outcomes for the Freestyle aortic ... more Objectives: We sought to describe the hemodynamic and clinical outcomes for the Freestyle aortic root bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in a large multicenter cohort prospectively followed for 8 years. Methods: A total of 700 patients (651 [93%] Ͼ60 years of age) at 8 centers in North America were followed prospectively after aortic valve replacement with the Freestyle stentless bioprosthesis; the implant technique was subcoronary in 500, total root in 162, and root inclusion in 38. Follow-up was 3395 patient-years (4.9 Ϯ 2.3 years per patient). Clinical and echocardiographic follow-up was prospectively obtained at yearly intervals. Results: For the subcoronary, total root, and root inclusion groups, actuarial freedom from valve-related death was 96.8% (SE 3.0%), 92.3% (SE 7.7%), and 90.9% (SE 11.2%), respectively, and freedom from structural deterioration was 98.6% (SE 2.0%), 100.0% (SE 0.0%), and 100.0% (SE 0.0%), respectively. Hemodynamics remained excellent at 6 years. Freedom from moderate or more aortic regurgitation was 86.0% (SE 5.1%), 98.7% (SE 3.9%), and 97.3% (SE 6.6%), respectively. Gradients were slightly lower (P ϭ .0009), and the effective orifice area (P ϭ .02) and freedom from aortic regurgitation were slightly higher (P ϭ .03) with total root than subcoronary implantation. Conclusions: The Freestyle stentless aortic root bioprosthesis is a versatile option for aortic valve replacement. Measures of clinical outcomes and prosthesis durability remain excellent in multicenter follow-up through 8 years in a population predominantly older than 60 years at the time of the operation.
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