Topical Versus Intravenous Tranexamic Acid in Patients Undergoing Cardiac Surgery: The DEPOSITION Randomized Controlled Trial.

BACKGROUND: Although intravenous tranexamic acid is used in cardiac surgery to reduce bleeding and transfusion, topical tranexamic acid results in lower plasma concentrations compared to intravenous tranexamic acid, which may lower the risk of seizures. We aimed to determine whether topical tranexamic acid reduces the risk of in-hospital seizure without increasing the risk of transfusion among cardiac surgery patients. METHODS: We conducted a multicenter, double dummy, blinded, randomized controlled trial of patients recruited by convenience sampling in academic hospitals undergoing cardiac surgery with cardiopulmonary bypass. Between September 17, 2019, and November 28, 2023, a total of 3242 patients from 16 hospitals in 6 countries were randomly assigned (1:1 ratio) to receive either intravenous tranexamic acid (control) through surgery or topical tranexamic acid (treatment) at the end of surgery. The primary outcome was seizure, and the secondary outcome was red blood cell transfusion. After the last planned interim analysis-when 75% of anticipated participants had completed follow up-the Data and Safety Monitoring Board recommended to terminate the trial, and upon unblinding, the Operations Committee stopped the trial for safety. RESULTS: Among 3242 randomized patients (mean age, 66.0 years; 77.7% male), in-hospital seizure occurred in 4 of 1624 patients (0.2%) in the topical group and in 11 of 1628 patients (0.7%) in the intravenous group (absolute risk difference, -0.5%; 95% CI, -0.9 to 0.03; P = .07). Red blood cell transfusion occurred in 570 patients (35.1%) in the topical group and in 433 (26.8%) in the intravenous group (absolute risk difference, 8.3%; 95% CI, 5.2 to 11.5; P = .007). The absolute risk difference in transfusion of ≥4 units of red blood cells in the topical group compared to the intravenous group was 8.2% (95% CI, 3.4 to 12.9). CONCLUSIONS: Among patients having cardiac surgery, topical administration of tranexamic acid resulted in an 8.3% absolute increase in transfusion without reducing the incidence of seizure, compared to intravenous tranexamic acid.

Considerations for prostheses choice in multiple valve surgery.

OBJECTIVES: The prosthesis type for multiple valve surgery (replacement of two or more diseased native or prosthetic valves, replacement of two diseased valves with repair/reconstruction of a third, or replacement of a single diseased valve with repair/reconstruction of a second valve) remains inadequately evaluated. The clinical performance of multiple valve surgery with bioprostheses (BP) and mechanical prostheses (MP) was assessed to compare patient survival and composites of valve-related complications. METHODS: Between 1975 and 2000, 1245 patients had multiple valve surgery (BP 785, mean age 62.0 ± 14.7 years; and MP 460, mean age 56.9 ± 12.9 years). There were 1712 procedures performed [BP 969(56.6%) and MP 743(43.4%). Concomitant coronary artery bypass (conCABG) was BP 206(21.3%) and MP 105(14.1%) (p = 0.0002). The cumulative follow-up was BP 5131 years and MP 3364 years. Independent predictors were determined for mortality, valve-related complications and composites of complications. RESULTS: Unadjusted patient survival at 12 years was BP 52.1 ± 2.1% and MP 54.8 ± 4.6% (p = 0.1127), while the age adjusted survival was BP 48.7 ± 2.3% and MP 54.4 ± 5.0%. The predictors of overall mortality were age [Hazard Ratio (HR) 1.051, p < 0.0001], previous valve (HR 1.366, p = 0.028) and conCABG (HR 1.27, p = 0.021). The actual freedom from valve-related mortality at 12 years was BP 85.6 ± 1.6% and MP 91.0 ± 1.6% (actuarial p = 0.0167). The predictors of valve-related mortality were valve type (BP > MP) (2.61, p = 0.001), age (HR 1.032, p = 0.0005) and previous valve (HR 12.61, p < 0.0001). The actual freedom from valve-related reoperation at 12 years was BP 60.8 ± 1.9% and MP85.6 ± 2.1% (actuarial p < 0.001). The predictors of valve-related reoperation were valve type (MP > BP) (HR 0.32, p < 0.0001), age (HR 0.99, p = 0.0001) and previous valve (HR 1.38, p = 0.008) CONCLUSIONS: Overall survival (age adjusted) is differentiated by valve type over 10 and 12 years and valve-related mortality and valve-related reoperation favours the use of mechanical prostheses, overall for multiple valve surgery.

Early Clinical Outcomes of Hybrid Arch Frozen Elephant Trunk Repair With the Thoraflex Hybrid Graft.

BACKGROUND: Hybrid aortic arch surgery has evolved to include several technical variations, with most including an off-label use of a conventional thoracic endograft. We describe the early clinical outcomes of the Thoraflex Hybrid graft (Vascutek, Glasgow, Scotland) specifically designed for the treatment of complex arch and proximal descending aortic disease. METHODS: Between January 2014 and April 2017, 40 consecutive patients (66 ± 14 years of age, 45% women) underwent hybrid aortic arch and frozen elephant trunk repair with the multibranched Thoraflex Hybrid graft at 9 Canadian centers. Surgical indications included transverse arch or proximal descending aortic aneurysm in 100%, acute dissection in 10%, chronic dissection in 43%, and acute aortic rupture in 1 patient. Antegrade cerebral perfusion and moderate hypothermia (24.3 ± 1.8°C) were employed in all cases. RESULTS: All 40 device implants were successful. The 30-day or in-hospital mortality was 5%. Stroke and transient neurological deficits occurred in 5% and 3% of patients, respectively. Two (5%) patients experienced transient spinal cord ischemia-there were no instances of permanent paraplegia. Mean follow-up was 550 ± 328 days and late complications included type A aortic dissection in 1 patient, type B dissection in 2 patients, and further distal endografting in 2 patients. Survival at 30 days, 1 year, and 2 years was 95%, 95%, and 90%, respectively. CONCLUSIONS: Hybrid aortic arch and frozen elephant trunk repair with the Thoraflex Hybrid graft appears to be associated with good clinical outcomes, despite being early in the learning curve with this graft. Further investigation with this device is warranted to establish its role within the variations of hybrid arch repair.

Earlier recovery with beating-heart surgery: a comparison of 300 patients undergoing conventional versus off-pump coronary artery bypass graft surgery.

OBJECTIVE: To compare outcomes and cost of off-pump coronary artery bypass (OP-CAB) surgery versus cardiopulmonary bypass-assisted coronary artery bypass graft (CABG) surgery. DESIGN: Retrospective review. SETTING: A tertiary care university teaching hospital. PARTICIPANTS: Patients (n = 300) undergoing isolated CABG surgery performed by a single surgeon between July 1998 and February 2000. INTERVENTIONS: Two groups of patients were compared: 150 consecutive patients undergoing OP-CAB surgery and a matched cohort of 150 consecutive patients undergoing conventional CABG surgery. MEASUREMENTS AND MAIN RESULTS: The 2 groups were evenly matched in terms of age and incidence of diabetes, hypertension, peripheral vascular disease, left main disease, prior strokes, congestive heart failure, and recent infarctions. OP-CAB procedures required 3.3 grafts per patient versus 3.8 grafts per patient required for CABG surgery (p = 0.02). Overall mortality was 2.0% (1.3% in the OP-CAB surgery group v 2.7 % in the CABG surgery group; p = NS). Extubation times (6.6 hours v 9.5 hours; p = 0.003), surgical intensive care unit length of stay (39 hours v 49 hours; p = 0.03), and hospital length of stay (6.1 days v 7.0 days; p = 0.04) were all significantly shorter for the OP-CAB surgery group. The combined aggregate endpoints of death and major morbidity were significantly less in the OP-CAB surgery group (5.3% v 12.7%; p = 0.02). CONCLUSION: OP-CAB surgery is associated with low morbidity and mortality and accelerated recovery compared with conventional CABG surgery. OP-CAB surgery may represent the ideal revascularization strategy for patients at high risk for undergoing cardiopulmonary bypass.