Five-Year Outcomes after On-Pump and Off-Pump Coronary-Artery Bypass.

BACKGROUND: Coronary-artery bypass grafting (CABG) surgery may be performed either with cardiopulmonary bypass (on pump) or without cardiopulmonary bypass (off pump). We report the 5-year clinical outcomes in patients who had been included in the Veterans Affairs trial of on-pump versus off-pump CABG. METHODS: From February 2002 through June 2007, we randomly assigned 2203 patients at 18 medical centers to undergo either on-pump or off-pump CABG, with 1-year assessments completed by May 2008. The two primary 5-year outcomes were death from any cause and a composite outcome of major adverse cardiovascular events, defined as death from any cause, repeat revascularization (CABG or percutaneous coronary intervention), or nonfatal myocardial infarction. Secondary 5-year outcomes included death from cardiac causes, repeat revascularization, and nonfatal myocardial infarction. Primary outcomes were assessed at a P value of 0.05 or less, and secondary outcomes at a P value of 0.01 or less. RESULTS: The rate of death at 5 years was 15.2% in the off-pump group versus 11.9% in the on-pump group (relative risk, 1.28; 95% confidence interval [CI], 1.03 to 1.58; P=0.02). The rate of major adverse cardiovascular events at 5 years was 31.0% in the off-pump group versus 27.1% in the on-pump group (relative risk, 1.14; 95% CI, 1.00 to 1.30; P=0.046). For the 5-year secondary outcomes, no significant differences were observed: for nonfatal myocardial infarction, the rate was 12.1% in the off-pump group and 9.6% in the on-pump group (P=0.05); for death from cardiac causes, the rate was 6.3% and 5.3%, respectively (P=0.29); for repeat revascularization, the rate was 13.1% and 11.9%, respectively (P=0.39); and for repeat CABG, the rate was 1.4% and 0.5%, respectively (P=0.02). CONCLUSIONS: In this randomized trial, off-pump CABG led to lower rates of 5-year survival and event-free survival than on-pump CABG. (Funded by the Department of Veterans Affairs Office of Research and Development Cooperative Studies Program and others; ROOBY-FS ClinicalTrials.gov number, NCT01924442 .).

Surgeon judgment and utility of transit time flow probes in coronary artery bypass grafting surgery.

IMPORTANCE: Transit time flow (TTF) probes may be useful for predicting long-term graft patency and assessing grafts intraoperatively in patients undergoing coronary artery bypass grafting (CABG); however, studies of TTF probe use are limited. OBJECTIVE: To examine 1-year graft patency and intraoperative revision rates in patients undergoing CABG based on intraoperative TTF assessment. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of a multicenter randomized clinical trial conducted at 18 Veterans Affairs hospitals using the Randomized On/Off Bypass (ROOBY) Trial data set. Of the original 2203 patients undergoing CABG surgery with or without cardiopulmonary bypass from February 1, 2002, through May 31, 2008, we studied a subset of 1607 who underwent TTF probe analysis of 1 or more grafts during surgery. EXPOSURES: Use of TTF probes to assess graft flow and pulsatility index (PI) values. The decision to revise a graft was based on the judgment of the attending surgeon. MAIN OUTCOMES AND MEASURES: Rates of 1-year FitzGibbon grade A patency and intraoperative revision were compared based on TTF measurements (<20 [low flow] vs ≥20 mL/min [normal flow]) and PI values (<3, 3-5, and >5). RESULTS: We measured TTF and/or PI in 2738 grafts, and 1-year patency was determined in 1710 (62.5%) of these grafts. FitzGibbon grade A patency occurred significantly less often in grafts with a TTF with low flow (259 of 363 [71.3%]) than in those with normal flow (1174 of 1347 [87.2%]; P < .01). FitzGibbon grade A patency was also inversely correlated with increasing PI values, as found in 936 of 1093 grafts (85.6%) with a PI less than 3, 136 of 182 grafts (74.7%) with a PI of 3 to 5, and 91 of 134 grafts (67.9%) with a PI greater than 5 (P ≤ .01). Intraoperative graft revision was more frequent in grafts with low flow (44 of 568 [7.7%]) than in those with normal flow (8 of 2170 [0.4%]; P < .01). Graft revision was also more frequent as PI increased (12 of 1827 [0.7%] with a PI <3, 9 of 307 [2.9%] with a PI 3-5, and 9 of 155 [5.8%] with a PI >5; P < .01). CONCLUSIONS AND RELEVANCE: Intraoperative TTF probe data may be helpful in predicting long-term patency and in the decision of whether to revise a questionable graft for patients undergoing CABG surgery.

Comparing off-pump and on-pump clinical outcomes and costs for diabetic cardiac surgery patients.

BACKGROUND: Observational studies have documented an off-pump over on-pump advantage for high-risk patients, including diabetic patients. Randomized trials have not confirmed this advantage. The VA Randomization On Versus Off Bypass (ROOBY) trial randomly assigned 2,203 coronary artery bypass graft surgery (CABG) patients at 18 sites to either on-pump (n=1,099) or off-pump (n=1,104) procedures. An a priori ROOBY aim was to evaluate treatment impact on diabetic patients. METHODS: Actively treated diabetic patients (n=835, receiving oral hypoglycemic or insulin medications) received off-pump CABG (n=402) or on-pump CABG (n=433). The primary ROOBY trial endpoints were a short-term composite (30-day operative death or major complications) and a 1-year composite (death, nonfatal acute myocardial infarction, or repeat revascularization). Secondary ROOBY endpoints included 1-year all-cause death, 1-year graft patency, 1-year changes from baseline in neurocognitive status and health-related quality of life, and costs. RESULTS: Diabetic patients' risk factors at baseline were balanced across treatments. For diabetic patients, the primary short-term composite outcome rate showed a worse trend for off-pump (8.0%) than on-pump (3.9%, p=0.013), with no difference in the 1-year primary composite outcome or 1-year death rate. One-year patency was 83.1% off-pump versus 88.4% on-pump (p=0.004). No differences were found in neurocognitive, health-related quality of life, discharge cost, and 1-year cumulative cost. CONCLUSIONS: Concordant with the ROOBY trial's overall findings, off-pump CABG yielded no advantage over on-pump CABG for actively treated diabetic patients. The 1-year graft patency was lower and the short-term composite trended higher for off-pump CABG, with no other significant outcome or cost differences.

Effect of clopidogrel use post coronary artery bypass surgery on graft patency.

BACKGROUND: Clopidogrel use post coronary artery bypass grafting (CABG) has become more popular under the assumption that it improves graft patency. The purpose of this sub-analysis from the Randomized On and Off-Pump Bypass (ROOBY) trial is to evaluate the role of clopidogrel use post CABG to improve graft patency when added to standard aspirin therapy. METHODS: The ROOBY trial was a multi-center, randomized, controlled clinical trial that compared on-pump versus off-pump coronary artery bypass grafting (CABG). Clopidogrel use post CABG was left at the discretion of the operator. Detailed data regarding the use and timing of clopidogrel post CABG were collected prospectively, along with 1-year angiograms to evaluate graft status. RESULTS: Of the 2,203 subjects undergoing CABG, 953 patient records had complete clopidogrel use and 1-year angiographic data. Of these, 345 (36.2%) received clopidogrel post CABG prior to discharge. Compared with patients with no post-CABG clopidogrel use, baseline characteristics were similar for the clopidogrel group except for the following: lower preoperative aspirin use (80.2% vs 86.7%, p = 0.009); higher preoperative clopidogrel use (23.5% vs 14.0%, p < 0.001), less on-pump (35.9% vs 55.9%, p < 0.0001); and lower endoscopic vein harvesting (30.8% vs 42.5%, p < 0.001) rates. Overall 1-year graft patency rates were not different between the clopidogrel and no-clopidogrel groups (86.5% vs 85.3%, p = 0.43). Multivariable analyses did not alter these findings. CONCLUSIONS: This study suggests that routine post-CABG clopidogrel use may not translate to improved 1-year graft patency. Future studies appear warranted to better define the role of more aggressive antiplatelet therapy post CABG on graft patency and clinical outcomes.

Chronic obstructive pulmonary disease impact upon outcomes: the veterans affairs randomized on/off bypass trial.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) are at inherent risk for higher rates of adverse events after coronary artery bypass graft surgery (CABG). As compared with on-pump CABG (ONCAB), it has been suggested that beating heart or off-pump CABG (OPCAB) may differentially benefit high-risk COPD patients. METHODS: Intraoperative, 30-day and 1-year outcomes were compared for COPD patients randomized to OPCAB (n = 220) versus ONCAB (n = 238) within the Veterans Affairs' Randomized On/Off Bypass (ROOBY) trial. As COPD patients may more likely incur adverse post-CABG outcomes, a propensity analysis was performed comparing all ROOBY patients with COPD (n = 458) versus those without COPD (n = 1,745). RESULTS: For COPD patients, the baseline characteristics were similar between the 2 revascularization approaches. In these patients, the intraoperative complication rate was higher with OPCAB than ONCAB (21.9% vs 10.1%, respectively; p < 0.001), but there were no significant differences in the 30-day (7.3% vs 7.6%, p = 1.00) or 1-year composite outcome rates (9.5% vs 7.1%, p = 0.39) between the groups. Comparing the COPD patients with propensity-matched non-COPD patients, there was no difference in 1-year major adverse cardiovascular events (including the 1-year composite major adverse cardiac events (MACE) outcome, as well as the individual MACE outcomes for all cause death, acute myocardial infarction, or repeat revascularization). CONCLUSIONS: In COPD patients, there were more intraoperative complications and no differences in 30-day or 1-year outcomes with OPCAB as compared with ONCAB. Similar to patients without COPD, there was no benefit to using an OPCAB approach in COPD patients.

On-pump versus off-pump coronary artery bypass surgery: cost-effectiveness analysis alongside a multisite trial.

BACKGROUND: Questions have been raised about the costs and outcomes for patients receiving on-pump and off-pump coronary artery bypass graft surgery. As part of the Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) multisite trial, a cost-effectiveness analysis was performed to compare on-pump versus off-pump patients' quality-adjusted life-years and costs at 1 year. METHODS: One-year outcomes and costs (standardized to 2010 dollars) were estimated in multivariate regression models, controlling for site and baseline patient factors. The 1-year incremental cost-effectiveness analysis ratio with 95% confidence intervals was calculated using bootstrapping. RESULTS: Eighteen centers randomly assigned 2,203 participants to on-pump (n=1,099) versus off-pump (n=1,104) coronary artery bypass graft surgery. Both groups' quality of life improved significantly after surgery (p<0.01) compared with baseline, but no differences were found between treatment groups. Adjusted cost of the index coronary artery bypass graft surgery hospitalization was $36,046 on-pump and $36,536 off-pump (p=0.16). At 1 year, on-pump adjusted cost was $56,023 versus $59,623 off-pump (p=0.046). Off-pump-to-on-pump conversions after first distal anastomosis (4.8%) had significantly higher 1-year costs. Excluding conversions, there were no significant differences between treatments for index hospitalization or 1-year total costs. CONCLUSIONS: At 1 year, off-pump coronary artery bypass graft surgery was more expensive than on-pump when late off-pump-to-on-pump conversions were included. Excluding late conversions, there was no difference in quality-adjusted life-years or costs. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00032630; http://clinicaltrials.gov/ct2/show/NCT00032630.

Impact of lipid-lowering medications and low-density lipoprotein levels on 1-year clinical outcomes after coronary artery bypass grafting.

BACKGROUND: Studies investigating lipid-lowering medication (LLM) use and LDL levels in coronary artery bypass grafting patients are limited. STUDY DESIGN: The Veterans Affairs Randomized On/Off Bypass Trial's patient records were analyzed for LLM use and 1-year LDL levels. Mortality, acute MI (AMI), and repeat revascularization rates were compared at 1 year between patients with and without LLM at discharge. In addition, AMI, repeat revascularization, and graft patency were compared between patients that did and did not achieve a 1-year LDL target level of <100 mg/dL. RESULTS: The LLM data were available for 86.4% (1,904 of 2,203) of patients. Rates of LLM use were 83.4% (1,316 of 1,577) at discharge and 90.0% (1,713 of 1,904) at 1 year. Patients discharged after coronary artery bypass grafting on LLMs had a significantly lower 1-year mortality rate (1.9% vs 5.4%; p < 0.01) than those not discharged on LLM, and 1-year AMI and repeat revascularization rates were not significantly different. Of the patients with 1-year LDL measurements, 69.4% (1,200 of 1,729) achieved an LDL target level of <100 mg/dL. No differences were seen in AMI, revascularization, or graft occlusion rates between patients who achieved target LDL levels and those who did not. CONCLUSIONS: Rates of LLM use among veterans post-coronary artery bypass grafting are high. Discharge on LLM might be associated with improved intermediate-term survival. Patients who achieved an LDL target of <100 mg/dL at 1-year did not experience improved 1-year clinical outcomes or graft patency. Longer-term follow-up might reveal differences in cardiac outcomes related to achievement of target LDL levels.

Changes in health-related quality of life in off-pump versus on-pump cardiac surgery: Veterans Affairs Randomized On/Off Bypass trial.

BACKGROUND: The relative benefits of performing coronary artery bypass graft surgery off-pump versus on-pump continue to be debated. A critical, patient-centered outcome is health-related quality of life; yet there has been limited evaluation in large-scale, multicenter trials of the off-pump versus on-pump impact upon quality of life. METHODS: The Veterans Affairs Randomized On/Off Bypass trial randomized 2,203 nonemergent patients to off-pump or on-pump from February 2002 to May 2007. Patients completed a general quality of life survey (VR-36) and a disease-specific quality of life survey, the Seattle Angina Questionnaire (SAQ), prior to surgery, then again at 3 and 12 months post-bypass. RESULTS: Of the 2,130 1-year survivors, 1,805 patients (85%) completed 1-year surveys. Randomization resulted in comparable baseline patient characteristics, including VR-36 and SAQ scores. At 3 months and 1-year post-procedure, there were no clinically relevant differences between off-pump and on-pump patients in any of the quality of life measures. Both groups had statistically significant, comparable improvements in the physical component scale of the VR-36, and in the SAQ scales. CONCLUSIONS: For this trial's male, low-to-moderate risk, veteran population, there were no significant differences between off-pump and on-pump with regard to 1-year general and disease-specific quality of life outcomes. Both treatment arms experienced some improvements by 3 months, with continued improvements through 1-year post-bypass.

Off-Pump coronary artery bypass surgery is associated with worse arterial and saphenous vein graft patency and less effective revascularization: Results from the Veterans Affairs Randomized On/Off Bypass (ROOBY) trial.

BACKGROUND: The Department of Veterans Affairs Randomized On/Off Bypass (ROOBY) trial compared clinical and angiographic outcomes in off-pump versus on-pump coronary artery bypass graft (CABG) surgery to ascertain the relative efficacy of the 2 techniques. METHODS AND RESULTS: From February 2002 to May 2007, the ROOBY trial randomized 2203 patients to off-pump versus on-pump CABG. Follow-up angiography was obtained in 685 off-pump (62%) and 685 on-pump (62%) patients. Angiograms were analyzed (blinded to treatment) for FitzGibbon classification (A=widely patent, B=flow limited, O=occluded) and effective revascularization. Effective revascularization was defined as follows: All 3 major coronary territories with significant disease were revascularized by a FitzGibbon A-quality graft to the major diseased artery, and there were no new postanastomotic lesions. Off-pump CABG resulted in lower FitzGibbon A patency rates than on-pump CABG for arterial conduits (85.8% versus 91.4%; P=0.003) and saphenous vein grafts (72.7% versus 80.4%; P<0.001). Fewer off-pump patients were effectively revascularized (50.1% versus 63.9% on-pump; P<0.001). Within each major coronary territory, effective revascularization was worse off pump than on pump (all P≤0.001). The 1-year adverse cardiac event rate was 16.4% in patients with ineffective revascularization versus 5.9% in patients with effective revascularization (P<0.001). CONCLUSIONS: Off-pump CABG resulted in significantly lower FitzGibbon A patency for arterial and saphenous vein graft conduits and less effective revascularization than on-pump CABG. At 1 year, patients with less effective revascularization had higher adverse event rates. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00032630.

Outcomes after conversion in the Veterans Affairs randomized on versus off bypass trial.

BACKGROUND: The Randomized On versus Off Bypass trial reported conversion of 12.4% (n = 137) off-pump coronary artery bypass (OPCAB) patients and 3.6% (n = 40) on-pump cardiopulmonary bypass (CPB) patients. This paper explored outcomes after conversions. METHODS: Elective and urgent CABG patients (n = 2,203) at 18 sites were studied. Randomization within 54 participating surgeons occurred preoperatively, after which conversion occurred if clinically indicated. Conversion reasons and outcomes were captured prospectively with additional details retrospectively extracted from patient records by a core clinical group. RESULTS: Conversion rates varied considerably across participating surgeons. Converted OPCAB patients had more right coronary disease and coronary targets less than 1.5 mm. Conversions were elective in 49.3% of cases, urgent in 27.2%, or emergent in 23.5%. Elective conversions were mainly for poor exposure-intramyocardial vessel (35.8%). Urgent and emergent conversions were usually for hemodynamic instability (89.2% and 75.0%, respectively). Compared with CPB and OPCAB patients, OPCAB-converted patients had more 30-day complications and deaths (composite outcome rate of 5.7% and 5.5% vs 17.5% respectively, p < 0.001). Thirty-day outcomes for OPCAB-converted patients trended worse for emergent versus elective conversions (31.3% vs 13.4%, respectively, p = 0.05). One-year composite outcome rate (death, nonfatal myocardial infarction or revascularization) in OPCAB-converted patients was worse than in CPB patients (13.5% vs 7.1%, p = 0.02), but similar to OPCAB-nonconverted (9.4%). CONCLUSIONS: The OPCAB patients requiring conversion had worse 30-day and 1-year outcomes. The OPCAB patients with right coronary artery disease or small targets were more often converted. The 30-day composite outcome trended worst for emergent OPCAB conversions.

Cognitive outcomes after on- versus off-pump coronary artery bypass surgery.

BACKGROUND: The Randomized On versus Off Bypass trial found no difference for a global cognitive outcome measure for patients receiving on-pump versus off-pump coronary artery bypass graft surgery (CABG). In this report, we present the baseline patient characteristics that were predictive of post-CABG cognitive decline as well as compare cognitive outcomes between treatment arms. METHODS: A neuropsychological battery was administered preoperatively and at 1 year after undergoing CABG. Stepwise regression was used to identify demographic or clinical risk factors associated with cognitive decline. Neuropsychological data were converted to demographically corrected T scores to provide impairment levels. RESULTS: Overall 1,156 patients (581 on-pump, 575 off-pump) completed match-paired neuropsychological assessments at baseline and 1-year follow-up. Baseline cognitive score, age, education level, and ethnicity predicted cognitive decline after CABG. Only 20% of either group had mild impairment at baseline on three of the test scores, and less than 10% had severe impairment on individual tests at either time. Few subjects in either group transitioned to clinically impaired levels at follow-up on individual tests. CONCLUSIONS: At baseline, lower cognitive function, older age, lower education, and ethnicity other than white were predictive of cognitive decline after CABG. Patients in both groups demonstrated low frequencies of cognitive impairment on individual tests at baseline and follow- up, and few patients in either group were classified as impaired at 1-year follow-up on individual tests. In general, the Randomized On versus Off Bypass study documented that neither on-pump nor off-pump CABG adversely impacts long-term brain function.

On-pump versus off-pump coronary-artery bypass surgery.

BACKGROUND: Coronary-artery bypass grafting (CABG) has traditionally been performed with the use of cardiopulmonary bypass (on-pump CABG). CABG without cardiopulmonary bypass (off-pump CABG) might reduce the number of complications related to the heart-lung machine. METHODS: We randomly assigned 2203 patients scheduled for urgent or elective CABG to either on-pump or off-pump procedures. The primary short-term end point was a composite of death or complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure) before discharge or within 30 days after surgery. The primary long-term end point was a composite of death from any cause, a repeat revascularization procedure, or a nonfatal myocardial infarction within 1 year after surgery. Secondary end points included the completeness of revascularization, graft patency at 1 year, neuropsychological outcomes, and the use of major resources. RESULTS: There was no significant difference between off-pump and on-pump CABG in the rate of the 30-day composite outcome (7.0% and 5.6%, respectively; P=0.19). The rate of the 1-year composite outcome was higher for off-pump than for on-pump CABG (9.9% vs. 7.4%, P=0.04). The proportion of patients with fewer grafts completed than originally planned was higher with off-pump CABG than with on-pump CABG (17.8% vs. 11.1%, P<0.001). Follow-up angiograms in 1371 patients who underwent 4093 grafts revealed that the overall rate of graft patency was lower in the off-pump group than in the on-pump group (82.6% vs. 87.8%, P<0.01). There were no treatment-based differences in neuropsychological outcomes or short-term use of major resources. CONCLUSIONS: At 1 year of follow-up, patients in the off-pump group had worse composite outcomes and poorer graft patency than did patients in the on-pump group. No significant differences between the techniques were found in neuropsychological outcomes or use of major resources. (ClinicalTrials.gov number, NCT00032630.).

Does preoperative hemoglobin independently predict short-term outcomes after coronary artery bypass graft surgery?

BACKGROUND: The role of preoperative hemoglobin in predicting short-term coronary artery bypass graft (CABG) surgery outcomes has not been well established. This study investigated the association between preoperative hemoglobin level with 30-day operative mortality and perioperative complications. METHODS: For the period from 1997 to 2005, the Department of Veterans Affairs Continuous Improvement in Cardiac Surgery Program database was used to extract 36,658 CABG-only deidentified records for patients undergoing cardiopulmonary bypass. Univariate and multivariate statistical models were used to predict both mortality and morbidity outcomes for varying levels of hemoglobin. RESULTS: Unadjusted odds of 30-day operative mortality for patients with preoperative hemoglobin level less than 10 g/dL were 2.37 times higher than for patients with hemoglobin levels of 10 g/dL or greater (95% confidence interval: 1.84 to 3.05; p < 0.0001). Multivariable effect upon 30-day operative mortality decreased considerably (odds ratio = 1.29, 95% confidence interval: 0.99 to 1.68; p = 0.064). CONCLUSIONS: As several risk factors may occur concurrently with low hemoglobin, preoperative hemoglobin level less than 10 g/dL was not a strong independent predictor of 30-day operative mortality or perioperative morbidity in multivariate models for on-pump CABG-only patients. Hemoglobin and serum creatinine were correlated, with creatinine exhibiting the stronger association with mortality. These findings suggest that moderate or severe anemia may be intertwined with other risk factors, such as serum creatinine or congestive heart failure. For a CABG patient subgroup presenting with a complex clinical preoperative profile, therefore, risk-model approaches may be inherently limited in separately identifying the predictors of anemic patients' outcomes.

A study design to assess the safety and efficacy of on-pump versus off-pump coronary bypass grafting: the ROOBY trial.

BACKGROUND: Since the late 1960s, coronary artery bypass graft (CABG-only) procedures were traditionally performed using a heart-lung machine on an arrested heart (on-pump). Over the past decade, an increasing number CABG-only procedures were performed on a beating heart (off-pump). Advocates of the off-pump approach expect to reduce many of the adverse side effects related to using the heart-lung machine, while advocates for the on-pump procedure raise concerns related to graft patency rates and long-term event-free survival for the off-pump technique. PURPOSE: The U.S. Department of Veteran Affairs (VA) Cooperative Studies Program funded a randomized, multicenter clinical trial comparing the clinical and resource-related outcomes following on-pump versus off-pump techniques for veterans undergoing a non-emergent CABG-only procedure. The planning committee was faced with several critically important challenges to assure feasibility of study costs and required sample size; generalizability to non-VA surgical practices; and comparability of clinically meaningful results. These challenges are discussed. METHODS: This study is a prospective, randomized, multicenter, single blinded (patient) clinical trial that compares on-pump and off-pump techniques for veterans requiring non-emergent CABG-only procedures. There will be 2200 patients randomized at 17 VA Medical Centers when the five-year recruitment period ends on 15 April 2007. There are two primary objectives: a short-term objective to assess the immediate impact of the two techniques on 30-day mortality/morbidity and a long-term objective to assess one-year mortality/morbidity. Major secondary outcomes are one-year graft patency rates and change in neuropsychological assessments from baseline to one year. All patients are assessed at 30 days post-surgery or discharge from the hospital, whichever is latest, and at one-year post-surgery. RESULTS: During planning, several key issues had to be decided. These included 1) choosing primary objectives: a short-term (30-day) and a long-term (one-year) objective were chosen; 2) choosing primary outcome measures: composite measures were selected to ensure sufficient end-points; 3) standardization of surgical techniques: minimal standardization required but guidelines and continuing discussions on both techniques provided; 4) establishing criteria for surgeons and residents for participation: surgeons required to have completed 20 off-pump procedures prior to doing study procedures and residents, in presence of study surgeon, capable of doing either procedure; 5) identifying metrics of cognitive dysfunction sensitive to treatment: a neuropshychologist hired who centrally monitors cognitive functioning testing; and 6) blinding participants of surgical procedure: attempt to blind participants. LIMITATIONS: Areas of concern are whether all surgeons sufficiently experienced on the off-pump procedure, should residents have been allowed to do study surgeries, should techniques have been standardized more and were the best neurocognitive tests selected. CONCLUSION: The study design presented allows for a balanced and fair assessment of the on-pump and off-pump CABG procedures across a diversity of clinical outcomes and resource use metrics. Its results have the potential to influence clinical cardiac surgical practice in the future.

Patency outcomes of aortic connectors.

OBJECTIVE: : Controlled outcome analysis of mechanical aortic connectors for proximal saphenous vein bypass graft anastomosis is lacking. We report the clinical and angiographic outcome of patients receiving the Symmetry aortic connector (St. Jude Medical, Inc St. Paul, MN, US) within a multicenter, prospective, randomized study. METHODS: : Twenty-five patients at 3 study sites received aortic connectors at the time of coronary artery bypass surgery. Protocol-defined angiographic follow-up was completed in 19 of 25 patients (76%) at time-points up to 14 months postoperatively; 32 connector anastomoses were evaluated in these 19 patients. Beating heart surgery was performed in 17 patients, and 2 were performed with cardiopulmonary bypass. Age was 69.7 ± 8.1 year; all patients were males. RESULTS: : The connector anastomosis patency rate was 15.6% (5/32). There were no deaths during the follow-up period. Four patients (21%) suffered myocardial infarction and 2 additional patients (10.5%) required percutaneous coronary interventions; one of who required 3 percutaneous coronary interventions, the other received one percutaneous coronary intervention. CONCLUSIONS: : In this nonrandomized cohort of patients, occlusion rate with Symmetry connectors was significantly greater than anticipated. Patients who have received these connectors during coronary artery bypass surgery may require closer follow-up and evaluation. While the manufacturer has stopped producing this device, there has been no recall of the product, clinical support remains ongoing, and next generation connectors have now been marketed. Consideration should be given to discontinuation of the clinical use of Symmetry connectors.

Prescription-filling rates for key medications in Veterans Affairs patients after coronary artery bypass grafting.

PURPOSE: The six-month prescription-filling rates for key secondary-prevention drugs in Department of Veterans Affairs (VA) patients who had undergone coronary artery bypass grafting (CABG) were studied. METHODS: Patient records for elective CABG from April 2000 through March 2002 (divided into four six-month periods) were analyzed. The study population included 8925 CABG-only patients surviving to hospital discharge. For each six-month period and in aggregate, the primary study endpoint was the six-month prescription-filling rate. RESULTS: Across the four six-month periods, prescription-filling rates increased for all categories of medications studied. There were modest progressive increases for lipid-lowering agents, statins, -blockers, angiotensin-converting-enzyme Inhibitors, and angiotensin-receptor blockers. The antithrombotic-filling rate averaged 88.5%. Filling rates for aspirin were much higher than for aspirin alternatives. CONCLUSION: Prescription-filling rates for post-CABG medications in VA facilities were generally high and suggested compliance with guidelines for the prevention of cardiovascular events.