Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery : post hoc analysis and interpretation of phase III results

OBJECTIVES: In a multicentre, randomized-controlled, phase III trial in complex cardiovascular surgery (Randomized Evaluation of Fibrinogen vs Placebo in Complex Cardiovascular Surgery: REPLACE), single-dose human fibrinogen concentrate (FCH) was associated with the transfusion of increased allogeneic blood products (ABPs) versus placebo. Post hoc analyses were performed to identify possible reasons for this result. METHODS: We stratified REPLACE results by adherence to the transfusion algorithm, pretreatment fibrinogen level (2g/l) and whether patients were among the first 3 treated at their centre. RESULTS: Patients whose treatment was adherent with the transfusion algorithm [FCH, n=47 (60.3%); placebo, n=57 (77.0%); P=0.036] received smaller quantities of ABPs than those with non-adherent treatment (P2g/l and fewer patients undergoing thoracoabdominal aortic aneurysm repair. CONCLUSIONS: None of the patient stratifications provided a clear explanation for the lack of efficacy seen for FCH in the REPLACE trial versus the positive phase II outcomes. However, together, the 3 factors demonstrated trends favouring FCH. Less familiarity with the protocol and procedures and unavoidable differences in the study populations may explain the differences seen between the phase II study and REPLACE.Peer reviewe

Postoperative Staphylococcus aureus Infections in Patients With and Without Preoperative Colonization

Importance Staphylococcus aureus surgical site infections (SSIs) and bloodstream infections (BSIs) are important complications of surgical procedures for which prevention remains suboptimal. Contemporary data on the incidence of and etiologic factors for these infections are needed to support the development of improved preventive strategies.Objectives To assess the occurrence of postoperative S aureus SSIs and BSIs and quantify its association with patient-related and contextual factors.Design, Setting, and Participants This multicenter cohort study assessed surgical patients at 33 hospitals in 10 European countries who were recruited between December 16, 2016, and September 30, 2019 (follow-up through December 30, 2019). Enrolled patients were actively followed up for up to 90 days after surgery to assess the occurrence of S aureus SSIs and BSIs. Data analysis was performed between November 20, 2020, and April 21, 2022. All patients were 18 years or older and had undergone 11 different types of surgical procedures. They were screened for S aureus colonization in the nose, throat, and perineum within 30 days before surgery (source population). Both S aureus carriers and noncarriers were subsequently enrolled in a 2:1 ratio.Exposure Preoperative S aureus colonization.Main Outcomes and Measures The main outcome was cumulative incidence of S aureus SSIs and BSIs estimated for the source population, using weighted incidence calculation. The independent association of candidate variables was estimated using multivariable Cox proportional hazards regression models.Results In total, 5004 patients (median [IQR] age, 66 [56-72] years; 2510 [50.2%] female) were enrolled in the study cohort; 3369 (67.3%) were S aureus carriers. One hundred patients developed S aureus SSIs or BSIs within 90 days after surgery. The weighted cumulative incidence of S aureus SSIs or BSIs was 2.55% (95% CI, 2.05%-3.12%) for carriers and 0.52% (95% CI, 0.22%-0.91%) for noncarriers. Preoperative S aureus colonization (adjusted hazard ratio [AHR], 4.38; 95% CI, 2.19-8.76), having nonremovable implants (AHR, 2.00; 95% CI, 1.15-3.49), undergoing mastectomy (AHR, 5.13; 95% CI, 1.87-14.08) or neurosurgery (AHR, 2.47; 95% CI, 1.09-5.61) (compared with orthopedic surgery), and body mass index (AHR, 1.05; 95% CI, 1.01-1.08 per unit increase) were independently associated with S aureus SSIs and BSIs.Conclusions and Relevance In this cohort study of surgical patients, S aureus carriage was associated with an increased risk of developing S aureus SSIs and BSIs. Both modifiable and nonmodifiable etiologic factors were associated with this risk and should be addressed in those at increased S aureus SSI and BSI risk

Prinos krevni kardioplegie pro ochranu myokardu pri aortokoronarnim bypassu u nemocnych s dysfunkci leve komory srdecni.

This study was done to compare the protective effect of blood and crystalloid cardioplegia in patients with left ventricular dysfunction with a view to the changes during early postoperative phase. All patients in this study were operated under general anaesthesia by the use of cardiopulmonary bypass. In both groups moderate systemic hypothermia and topical hypothermia were used. Internal mammary artery bypasses were implanted as last anastomoses. We can summarise that we didnt find significant differences in mortality, perioperative myocardial infarction rate and need of mechanical heart support in postoperative myocardial infarction rate and need of mechanical heart support in postoperative period between blood and crystalloid cardioplegia groups. The cardiospecific enzyme response was significantly lower in the blood cardioplegia group and the LVSW and LVSWI was significantly higher in the blood cardioplegia group one hour after operation. We conclude. that blood cardioplegia shows earlier improvement of myocardial function after the operation. Blood cardioplegia could be beneficial in patients with severe left ventricular dysfunction, because in these patients the left ventricular dysfunction in early hours after operation can reach the critical point leading to collapse of the circulation.Summary in EnglishAvailable from STL, Prague, CZ / NTK - National Technical LibrarySIGLECZCzech Republi

Early and mid-term outcomes of the aortic arch surgery: experience from the low-volume centre

AIM: The aim of this retrospective study was to examine the early and mid-term outcomes for patients undergoing elective aortic arch surgery over a 13-years period in the single low-volume centre. Results of aortic arch surgery published in the literature are usually results of high-volume centers, but the majority of institutions have much lower caseload. METHODS: From January 1999 to March 2013 total of 353 surgeries on thoracic aorta were performed in our institution. Only 30 procedures (8.5%) were elective aortic arch surgeries. This group of patients was analyzed. RESULTS: Deep hypothermia alone and hypothermia with ortograde cerebral perfusion was used in 7 (23%) and 23 (77%) patients respectively. Mean core temperature was 22°C (17 – 26°C). Cannulation sites was axillary artery or brachiocephalic trunk in 17 (57%), femoral artery in 8 (27%) and ascending aorta or aortic arch in 5 (16%). Mean hypothermic circulatory arrest time was 39 min (15 – 74 min). There was one death due to multiorgan failure; all-cause mortality at 30 days was 3.3%. The frequency of other complications was permanent neurological deficit in 2 (6.7%), temporary neurological deficit in 2 (6.7%) and renal failure requiring hemodialysis in 2 (6.7%) patients. In the follow-up 13 patients died, remaining 16 are still alive. CONCLUSION: Despite the lower caseload and technical problems manifested by a higher number of re-operations for bleeding, the all-cause mortality at 30 days as well as mid-term results are comparable with results reported by the high-volume centres

Influence of graft anastomosis and graft morphology on long-term patency of the saphenous vein after aortocoronary bypass

Objective. Several factors are involved in the preservation of graft function after surgical myocardial revascularization. This follow-up study aimed to evaluate the effects of vein graft anastomosis and graft morphology on long-term graft patency a minimum of 10 years after aortocoronary bypass grafting. Setting and Cohorts. This was a sub-analysis of a study that enrolled patients after isolated bypass surgery at the University Hospital Ostrava in order to evaluate the long-term graft patency of the saphenous vein after endoscopic harvest, a minimum of 10 years after aortocoronary bypass grafting. Methods. Fifty angiograms, with a total of 90 grafts, after isolated myocardial revascularization were visualized using coronary computed tomography angiography, with 50% luminal stenosis or greater considered significant. Results. The overall graft patency rate was 72.3%. The differences in occlusion rates between sequential and individual grafts were not statistically significant (P=0.156). All y-grafts were totally occluded. Graft and target artery diameters had a statistically significant influence on patency (P=1.000 and 0.381, respectively). Longer graft length and higher calcium scores were associated with statistically significant graft occlusion (P=0.033 and 0.005, respectively). Conclusion. Sequential grafts can be constructed safely, especially when the goal is complete myocardial revascularization