Enhanced recovery after cardiac surgery program to improve patient outcomes.

This article details the obstacles of implementing a cardiac-specific enhanced recovery after surgery (ERAS) program in a 919-bed not-for-profit community-based health system and the benefits of ERAS programs for different patient populations.

Insurance status is associated with acuity of presentation and outcomes for thoracic aortic operations.

BACKGROUND: Nonelective procedure status is the greatest risk factor for postoperative morbidity and mortality in patients undergoing thoracic aortic operations. We hypothesized that uninsured patients were more likely to require nonelective thoracic aortic operation due to decreased access to preventative care and elective surgical services. METHODS AND RESULTS: An observational study of the Society of Thoracic Surgeons Database identified 51 282 patients who underwent thoracic aortic surgery between 2007 and 2011 at 940 North American centers. Patients were stratified by insurance status (private insurance, Medicare, Medicaid, other insurance, or uninsured) as well as age <65 or ≥65 years to account for differences in Medicare eligibility. The need for nonelective thoracic aortic operation was highest for uninsured patients (71.7%) and lowest for privately insured patients (36.6%). The adjusted risks of nonelective operation were increased for uninsured patients (adjusted risk ratio, 1.77; 95% confidence interval, 1.70-1.83 for age <65 years; adjusted risk ratio, 1.46; 95% confidence interval, 1.29-1.62 for age ≥65 years) as well as Medicaid patients aged <65 years (adjusted risk ratio, 1.18; 95% confidence interval, 1.10-1.26) when compared with patients with private insurance. The adjusted risks of major morbidity or mortality were further increased for all patients aged <65 years without private insurance (adjusted risk ratios between 1.13 and 1.27). CONCLUSIONS: Insurance status was associated with acuity of presentation and major morbidity and mortality for thoracic aortic operations. Efforts to reduce insurance-based disparities in the care of patients with thoracic aortic disease seem warranted and may reduce the incidence of aortic emergencies and improve outcomes after thoracic aortic surgery.

Insurance status predicts acuity of thoracic aortic operations.

OBJECTIVE: Nonelective case status is the strongest predictor of mortality for thoracic aortic operations. We hypothesized that underinsured patients were more likely to require nonelective thoracic aortic surgery because of reduced access to preventative cardiovascular care and elective surgical services. METHODS: Between June 2005 and August 2011, 826 patients were admitted to a single aortic referral center and underwent 1 or more thoracic aortic operations. Patients with private insurance or Medicare (insured group, n=736; 89%) were compared with those with Medicaid or no insurance (underinsured group, n=90; 11%). RESULTS: The proportion of patients requiring nonelective surgery was higher for underinsured than insured patients (56% vs 26%, P<.0001). Multivariable analysis revealed underinsurance to be the strongest independent predictor of nonelective case status (odds ratio [OR], 2.67; P<.0001). Preoperative use of lipid-lowering medications (OR, 0.63; P<.009) or a history of aortic surgery (OR, 0.48; P<.001) was associated with a decreased risk of nonelective operation. However, after adjustment for differences in preoperative characteristics and case status, underinsurance did not confer an increased risk of procedural morbidity or mortality (adjusted OR, 0.94; P=.83) or late death (adjusted hazard ratio, 0.83, P=.58) when compared with insured patients. CONCLUSIONS: Underinsured patients were at the greatest risk of requiring nonelective thoracic aortic operation, possibly because of decreased use of lipid-lowering therapies and aortic surveillance. These data imply that greater access to preventative cardiovascular care may reduce the need for nonelective thoracic aortic surgery and lead to improved survival from thoracic aortic disease.

Would tirofiban have been shown non-inferior to abciximab had the TENACITY trial not been terminated for financial reasons?

OBJECTIVES: To investigate whether tirofiban would have been non-inferior to abciximab had the trial completed enrollment and place the termination of this trial in a broader research ethics context. BACKGROUND: TENACITY was terminated by the sponsor for financial reasons. At the time, event rates for the 2 treatment arms were unknown. METHODS: TENACITY was designed to compare tirofiban with abciximab in approximately 8,000 patients; however, enrollment was terminated after 383 (4.8%) patients. The primary end-point was a composite of 30-day death, myocardial infarction, and urgent target vessel revascularization. Non-inferiority was defined as the likelihood that tirofiban would preserve at least 50% of the ability of abciximab to reduce the primary end-point at 30 days, based on abciximab's demonstrated ability to reduce such events by 43% (relative risk, 0.573; 95% confidence interval [CI], 0.507-0.648; P < 0.001). To determine the probability of non-inferiority given the patients already enrolled, a Bayesian approach was used. RESULTS: The primary composite end-point occurred in 8.8% of patients randomized to abciximab versus 6.9% receiving high-bolus-dose tirofiban (odds ratio, 0.77; 95% CI, 0.37-1.64). The estimated conditional power for the test that tirofiban would be non-inferior to abciximab if all patients been enrolled is 93.7%. Using the estimated predictive power method, the likelihood was 84.8%. CONCLUSIONS: TENACITY was well powered to identify non-inferiority with tirofiban versus abciximab, and the patients enrolled strengthened the probability that this would have been the outcome had the trial been completed. When a clinical trial is terminated solely for financial reasons, it is incumbent upon the sponsor to provide proper patient follow-up and publication of the findings.

Association between endoscopic vs open vein-graft harvesting and mortality, wound complications, and cardiovascular events in patients undergoing CABG surgery.

CONTEXT: The safety and durability of endoscopic vein graft harvest in coronary artery bypass graft (CABG) surgery has recently been called into question. OBJECTIVE: To compare the long-term outcomes of endoscopic vs open vein-graft harvesting for Medicare patients undergoing CABG surgery in the United States. DESIGN, SETTING, AND PATIENTS: An observational study of 235,394 Medicare patients undergoing isolated CABG surgery between 2003 and 2008 at 934 surgical centers participating in the Society of Thoracic Surgeons (STS) national database. The STS records were linked to Medicare files to allow longitudinal assessment (median 3-year follow-up) through December 31, 2008. MAIN OUTCOME MEASURES: All-cause mortality. Secondary outcome measures included wound complications and the composite of death, myocardial infarction, and revascularization. RESULTS: Based on Medicare Part B coding, 52% of patients received endoscopic vein-graft harvesting during CABG surgery. After propensity score adjustment for clinical characteristics, there were no significant differences between long-term mortality rates (13.2% [12,429 events] vs 13.4% [13,096 events]) and the composite of death, myocardial infarction, and revascularization (19.5% [18,419 events] vs 19.7% [19,232 events]). Time-to-event analysis for those patients receiving endoscopic vs open vein-graft harvesting revealed adjusted hazard ratios [HRs] of 1.00 (95% CI, 0.97-1.04) for mortality and 1.00 (95% CI, 0.98-1.05) for the composite outcome. Endoscopic vein-graft harvesting was associated with lower harvest site wound complications relative to open vein-graft harvesting (3.0% [3654/122,899 events] vs 3.6% [4047/112,495 events]; adjusted HR, 0.83; 95% CI, 0.77-0.89; P < .001). CONCLUSION: Among patients undergoing CABG surgery, the use of endoscopic vein-graft harvesting compared with open vein-graft harvesting was not associated with increased mortality.

Intraoperative use of low-dose recombinant activated factor VII during thoracic aortic operations.

BACKGROUND: Numerous studies have supported the effectiveness of recombinant activated factor VII (rFVIIa) for the control of bleeding after cardiac procedures; however safety concerns persist. Here we report the novel use of intraoperative low-dose rFVIIa in thoracic aortic operations, a strategy intended to improve safety by minimizing rFVIIa exposure. METHODS: Between July 2005 and December 2010, 425 consecutive patients at a single referral center underwent thoracic aortic operations with cardiopulmonary bypass (CPB); 77 of these patients received intraoperative low-dose rFVIIa (≤60 µg/kg) for severe coagulopathy after CPB. Propensity matching produced a cohort of 88 patients (44 received intraoperative low-dose rFVIIa and 44 controls) for comparison. RESULTS: Matched patients receiving intraoperative low-dose rFVIIa got an initial median dose of 32 µg/kg (interquartile range [IQR], 16-43 µg/kg) rFVIIa given 51 minutes (42-67 minutes) after separation from CPB. Patients receiving intraoperative low-dose rFVIIa demonstrated improved postoperative coagulation measurements (partial thromboplastin time 28.6 versus 31.5 seconds; p=0.05; international normalized ratio, 0.8 versus 1.2; p<0.0001) and received 50% fewer postoperative blood product transfusions (2.5 versus 5.0 units; p=0.05) compared with control patients. No patient receiving intraoperative low-dose rFVIIa required postoperative rFVIIa administration or reexploration for bleeding. Rates of stroke, thromboembolism, myocardial infarction, and other adverse events were equivalent between groups. CONCLUSIONS: Intraoperative low-dose rFVIIa led to improved postoperative hemostasis with no apparent increase in adverse events. Intraoperative rFVIIa administration in appropriately selected patients may correct coagulopathy early in the course of refractory blood loss and lead to improved safety through the use of smaller rFVIIa doses. Appropriately powered randomized studies are necessary to confirm the safety and efficacy of this approach.