A Randomized Controlled Trial Comparing Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness.

BACKGROUND: Different preparations of fibrinogen concentrate are currently available. Two in vitro studies demonstrated the superiority of FibCLOT (LFB) in increasing clot firmness with respect to RiaSTAP (CSL Behring). The present trial involved a clinical model to test the hypothesis of superiority, with the increase in clot firmness as the primary end point. METHODS: Forty cardiac surgery patients were randomly allocated to receive a dose of 30 mg/kg FibCLOT or RiaSTAP after protamine administration in the presence of microvascular bleeding and a FIBTEM maximum clot firmness (MCF) <10 mm. Viscoelastic parameters were measured before and after fibrinogen supplementation: FIBTEM MCF, EXTEM MCF, and EXTEM clotting time (CT). RESULTS: The mean increase in FIBTEM MCF was 4 ± 1.2 mm (mean and standard deviation) in the FibCLOT group and 4 ± 1.6 mm in the RiaSTAP group (P = 1.000); the mean decrease in CT was 11. 2 ± 12.2 (mean and standard deviation) seconds in the FibCLOT group and 14. 8 ± 13 seconds in the RiaSTAP group (P = .372). In both groups, fibrinogen supplementation induced a significant (P = .001) increase in the FIBTEM MCF and EXTEM CT. The proportions of patients who did not experience an increase of 4 mm in the RiaSTAP group and the FibCLOT group were not statistically significantly higher (35% vs 20%, respectively, relative risk 2.15, 95% confidence interval 0.52-9.00, P = .288). CONCLUSIONS: In contrast to previous in vitro studies, we found that the effect of FibCLOT on MCF and CT was not significantly greater than that of RiaSTAP in cardiac surgery patients. Further studies in other clinical settings are warranted.

The Use of Pulmonary Artery Catheters and Echocardiography in the Cardiac Surgery Setting: A Nationwide Italian Survey.

OBJECTIVE: Wide variations exist in the use of pulmonary artery catheters (PACs) and echocardiography in the field of cardiac surgery. DESIGN: A national survey promoted by the Italian Association of Cardio-Thoracic Anesthesiologists and Intensive Care was conducted. SETTING: The study occurred in Italian cardiac surgery centers (n = 71). PARTICIPANTS: Anesthesiologists-intensivists were enrolled. INTERVENTIONS: Anonymous questionnaires were used to investigate the use of PACs and echocardiography in the operating room (OR) and intensive care unit (ICU). MEASUREMENTS AND MAIN RESULTS: A total of 257 respondents (32.2% response rate) from 59 centers (83.1% response rate) participated. Use of PACs seems less common in ORs (median insertion in 20% [5-70] of patients), with slightly higher use in ICUs; in about half of cases, it was the continuous cardiac output monitoring system of choice. Almost two-thirds of respondents recently inserted at least one PAC within a few hours of ICU admission, despite its need being largely preoperatively predictable. Protocols regulating PAC insertion were reported by 25.3% and 28% of respondents (OR and ICU, respectively). Transesophageal echocardiography (TEE) was performed intraoperatively in >75% of patients by 86.4% of respondents; only 23.7% stated that intraoperative TEE relied on anesthesiologists. Tissue Doppler and/or 3D imaging were widely available (87.4% and 82%, respectively), but only 37.8% and 24.3% of respondents self-declared skills in these modalities, respectively; 77.1% of respondents had no echocardiography certification, nor were pursuing certification (various reasons); 40.9% had not attended recent echocardiography courses. Lower PAC use was associated with university hospitals (OR: p = 0.014, ICU: p = 0.032) and with lower interventions/year (OR: p = 0.023). Higher independence in performing TEE was reported in university hospitals (OR: p < 0.001; ICU: p = 0.006), centers with higher interventions/year (OR: p = 0.019), and by respondents with less experience in cardiology (ICU: p = 0.046). CONCLUSION: Variability in the use of PACs and echocardiography was found. Protocols regulating the use of PACs seem infrequent. University centers use PACs less and have greater skills in TEE. Training and certifications in echocardiography should be encouraged.

Platelet reactivity in overweight and obese patients undergoing cardiac surgery.

Body mass index (BMI) and specifically overweight and obesity have been associated with an increased platelet reactivity in different series of patients. This information is derived by different laboratory platelet function tests (PFTs) like mean platelet volume (MPV), platelet microparticles, thromboxane B2 metabolites, and others. Point-of-care PFT, which are often used in cardiac surgery, are rarely addressed. The present study aims to verify platelet reactivity using multiple-electrode aggregometry (MEA) as a function of BMI in cardiac surgery patients. One-hundred ninety-eight cardiac surgery patients free from the effects of drugs acting on the P2Y12 receptor and undergoing cardiac surgery received MEA-PFT immediately before surgery. Platelet reactivity was compared between normal weight and overweight-obese subjects. There were 99 underweight/normal (BMI < 25), 60 overweight (BMI ≥ 25) and 39 obese (BMI ≥ 30) patients. Overweight-obese patients did not show higher platelet counts nor a clear platelet hyper-reactivity, when tested with MPV and MEA ADP test. At TRAPtest, the overweight/obese patients had a significantly (P = 0.011) higher platelet reactivity (median 118, interquartile range 106-136) than controls (median 112, interquartile range 101-123) and a higher rate of platelet hyper-reactivity (odds ratio 2.19, 95% confidence interval 1.15-4.16, P = 0.016) in a multivariable model. A minor association was found between the BMI and platelet reactivity at TRAPtest, with a higher degree of activity for increasing BMI. The BMI determines an increased thrombin-dependent platelet reactivity in cardiac surgery patients. Thrombin is extensively formed during cardiac surgery, and this may explain the lower postoperative bleeding observed in obese patients in previous studies.

Minimally Invasive Surgery for Simple Congenital Heart Defects: Preserving Aesthetics without Jeopardizing Patient Safety.

Minimally invasive surgeries for pediatric patients have been proposed for decades, with different approaches in mind. Minimal right axillary thoracotomy (MRAT), proposed two decades ago, allows the preservation of patients' safety alongside faster aesthetic and functional recovery. The MRAT did not become widely adopted due to the prejudice that to follow a minimally invasive approach, safety and efficacy must be compromised. With this study, we aim to compare MRAT to the standard median sternotomy approach with a focus on safety and clinical outcomes. Between January 2017 and April 2021, 216 patients diagnosed with ASD, pAVSD, or PAPVD underwent surgical repair with different approaches in the same period. MRAT was used for 78 patients, and median sternotomy was used for 138 patients. In this last group, standard median sternotomy (SMS) was used for 116 patients, while a minimal skin incision (SMS mini) was used for 22 patients. There were no major complications overall nor in each specific approach. MRAT enabled the successful repair of simple heart defects, providing similar post-operative and cardiological recovery. MRAT does not compromise patients' safety and does not prolong the duration of surgery once the learning curve is overcome, which is generally after 15-20 consecutive operations.

Influence of left ventricular unloading on pediatric post-cardiotomy veno-arterial extracorporeal life support outcomes.

Background: The effectiveness of veno-arterial extracorporeal life support (V-A ECLS) in treating neonatal and pediatric patients with complex congenital heart disease (CHD) and requiring cardio-circulatory assistance is well-known. Nevertheless, the influence of left ventricle (LV) distension and its countermeasure, namely LV unloading, on survival and clinical outcomes in neonates and children treated with V-A ECLS needs still to be addressed. Therefore, the aim of this study was to determine the effects of LV unloading on in-hospital survival and complications in neonates and children treated with V-A ECLS. Methods: The clinical outcomes of 90 pediatric patients with CHD under 16 years of age supported with V-A ECLS for post-cardiotomy cardiogenic shock (CS) were retrospectively reviewed in relationship with the presence or absence of an active LV unloading strategy. Results: The patient cohort included 90 patients (age 19.6 ± 31.54 months, 64.4% males), 42 of whom were vented with different techniques (38 with atrial septostomy (AS) or left atria cannula, two with cannula from LV apex, 1 with intra-aortic balloon pump (IABP), and one with pigtail across the aortic valve). The LV unloading strategy significantly increased the in-hospital survival (odds ratio [OR] = 2.74, 95% CI 1.06-7.08; p = 0.037). On the contrary, extracorporeal cardiopulmonary resuscitation decreased the related survival (OR = 0.32, 95% CI 1.09-0.96; p = 0.041). The most common complications were infections (28.8%), neurological injury (26%), and bleeding (25.6%). However, these did not differently occur in venting and no-venting groups. Conclusion: In pediatric patients with CHD supported with V-A ECLS for post-cardiotomy CS, the LV unloading strategy was associated with increased survival.

O2 delivery and CO2 production during cardiopulmonary bypass as determinants of acute kidney injury: time for a goal-directed perfusion management?

INTRODUCTION: Acute kidney injury (AKI) is common after cardiac operations. There are different risk factors or determinants of AKI, and some are related to cardiopulmonary bypass (CPB). In this study, we explored the association between metabolic parameters (oxygen delivery (DO2) and carbon dioxide production (VCO2)) during CPB with postoperative AKI. METHODS: We conducted a retrospective analysis of prospectively collected data at two different institutions. The study population included 359 adult patients. The DO2 and VCO2 levels of each patient were monitored during CPB. Outcome variables were related to kidney function (peak postoperative serum creatinine increase and AKI stage 1 or 2). The experimental hypothesis was that nadir DO2 values and nadir DO2/VCO2 ratios during CPB would be independent predictors of AKI. Multivariable logistic regression models were built to detect the independent predictors of AKI and any kind of kidney function damage. RESULTS: A nadir DO2 level < 262 mL/minute/m2 and a nadir DO2/VCO2 ratio < 5.3 were independently associated with AKI within a model including EuroSCORE and CPB duration. Patients with nadir DO2 levels and nadir DO2/VCO2 ratios below the identified cutoff values during CPB had a significantly higher rate of AKI stage 2 (odds ratios 3.1 and 2.9, respectively). The negative predictive power of both variables exceeded 90%. The most accurate predictor of AKI stage 2 postoperative status was the nadir DO2 level. CONCLUSIONS: The nadir DO2 level during CPB is independently associated with postoperative AKI. The measurement of VCO2-related variables does not add accuracy to the AKI prediction. Since DO2 during CPB is a modifiable factor (through pump flow adjustments), this study generates the hypothesis that goal-directed perfusion management aimed at maintaining the DO2 level above the identified critical value might limit the incidence of postoperative AKI.

Gender-based differences in platelet function and platelet reactivity to P2Y12 inhibitors.

BACKGROUND: Gender influences platelet biology. Women have a larger platelet count, but gender-based differences in platelet function remain debated. We performed a study addressing gender-based differences in platelet function using point-of-care platelet function tests (PFT). METHODS: The patient population consisted of 760 cardiac surgery patients where preoperative PFT (multiple-electrode aggregometry [MEA]) were available. Platelet count and function at the ADPtest and TRAPtest were compared in the overall population and separately in patients with or without residual effects of P2Y12 inhibitors. RESULTS: Women had a significantly (P = 0.001) higher platelet count but a non-significantly higher platelet reactivity to ADP. In clopidogrel-treated patients, the platelets ADP reactivity was significantly (P = 0.031) higher in women, and platelet count was the main determinant of platelet hyper-reactivity. Within patients under full clopidogrel effects, women with a platelet count ≥ 200,000 cells/µL had a significantly (P = 0.023) higher rate of high-on-treatment platelet reactivity (HTPR, 45.5%) with respect to males with a platelet count < 200,000 cells/µL (11.9%), with a relative risk of 6.2 (95% confidence interval 1.4-29). CONCLUSIONS: Our findings confirm that women have a larger platelet count than men, and that this is associated to a trend towards a higher platelet reactivity. HTPR is largely represented in women with a high platelet count. This generates the hypothesis that women requiring P2Y12 inhibitors could potentially benefit from larger doses of drug or should be treated with anti-platelet agents with a low rate of HTPR.

Jugular vs femoral vein for central venous catheterization in pediatric cardiac surgery (PRECiSE): study protocol for a randomized controlled trial.

BACKGROUND: Placement of central venous catheters (CVCs) is essential and routine practice in the management of children with congenital heart disease. The purpose of the present protocol is to evaluate the risk for infectious complications in terms of catheter colonization, catheter line-associated bloodstream infections, and catheter-related bloodstream infections (CRBSIs), and the mechanical complications from different central venous access sites in infants and newborns undergoing cardiac surgery. METHODS: One hundred sixty patients under 1 year of age and scheduled for cardiac surgery will be included in this randomized controlled trial (RCT); patients will be randomly allocated to the jugular or femoral vein arms. CVC insertion will be performed by one of three selected expert operators. DISCUSSION: The choice of the insertion site for central venous catheterization can influence the incidence and type of infectious complications in adults but this is not unanimously evidenced in the pediatric setting. The experimental hypothesis of this RCT is that the jugular insertion site is less likely to induce catheter colonization and CRBSI than the femoral site. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03282292 . Registered on 12 September 2017.

Validation of renal-risk models for the prediction of non-renal replacement therapy cardiac surgery-associated acute kidney injury.

BACKGROUND: Cardiac surgery-associated acute kidney injury (AKI) is a serious complication of cardiac surgery, even when renal replacement therapy (RRT) is not required. The existing risk models for cardiac surgery associated AKI are designed to predict AKI requiring RRT (RRT-AKI). The aim of this study is to validate three risk models for the prediction of RRT-dependent and non-RRT AKI after cardiac surgery. METHODS: Retrospective analysis on 7675 consecutive adult patients undergoing cardiac surgery with cardiopulmonary bypass. AKI was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria for stage 1 and 2. RRT AKI and non-RRT AKI were defined according to the need for RRT. Three risk models were validated separately for RRT and non-RRT AKI: the Cleveland Risk Score, the Bedside Risk Score, and the Simplified Renal Index Scoring Scheme. Discrimination power was assessed with Receiver Operating Characteristics analysis and c-statistics. RESULTS: There were 502 (6.5%) non-RRT AKI events, 128 (1.7%) RRT-AKI events, and 7045 (91.8%) no-events. The three models performed well for predicting RRT-AKI (c-statistics 0.75-0.79) and poorly for predicting non-RRT AKI (c-statistics 0.54-0.59). The models had an excellent calibration for RRT-AKI but not for non-RRT AKI. Preoperative serum creatinine and estimated glomerular filtration rate were associated with RRT AKI but not with non-RRT AKI. Mortality was 12.2% in non-RRT AKI and 46.9% in RRT-AKI, significantly (P = 0.001) higher than in patients without AKI (1.3%). CONCLUSIONS: The existing risk models are inadequate for predicting non-RRT AKI following cardiac surgery, both in terms of discrimination and calibration.

General Anesthesia Attenuates Brugada Syndrome Phenotype Expression: Clinical Implications From a Prospective Clinical Trial.

OBJECTIVES: This study investigates the electrocardiographic-electrophysiological effects of administration of anesthetic drugs for general anesthesia (GA) in patients with BrS at high risk of sudden cardiac death (SCD). BACKGROUND: The safety of anesthetic agents in Brugada syndrome (BrS) is under debate. METHODS: All consecutive patients with spontaneous type 1 BrS electrocardiographic (ECG) patterns undergoing epicardial ablation of the arrhythmogenic substrate (AS) under GA were enrolled. Anesthesia was induced with single bolus of propofol and maintained with sevofluorane. ECG measurements were collected before, immediately after, and 20 min after induction of GA. Three-dimensional maps during GA and after ajmaline indicated the epicardial AS before ablation. RESULTS: Thirty-six patients with BrS (32 male, 88.9%; mean age 38.8 ± 12.0 years) with a spontaneous type 1 ECG pattern underwent GA. Induction was performed using propofol at mean dose of 1.6 to 2.6 mg/kg (2.1 ± 0.3 mg/kg). Twenty-eight (28 of 36, 77.8%) patients showed a reversion to a nondiagnostic pattern. ST-segment elevation (0.32 ± 0.01 mV vs. 0.19 ± 0.02 mV; p < 0.001) and J-wave amplitude (0.47 ± 0.02 mV vs. 0.31 ± 0.03 mV; p < 0.001) decreased after propofol. The AS area during GA, in the absence of BrS pattern, significantly enlarged after administration of ajmaline (3.6 ± 0.5 cm2 vs. 20.3 ± 0.8 cm2). No patient developed malignant arrhythmias during GA induction and maintenance. CONCLUSIONS: This study shows that GA using single-bolus propofol and volatile anesthetics is safe in high-risk patients with BrS, and it may exert a modulating effect by reducing the manifestation of type 1 BrS pattern and AS in the form of epicardial abnormal ECGs. (Epicardial Ablation in Brugada Syndrome: An Extension Study of 200 BrS Patients; NCT03106701).

Hemodilution on cardiopulmonary bypass as a determinant of early postoperative hyperlactatemia.

OBJECTIVE: The nadir hematocrit (HCT) on cardiopulmonary bypass (CPB) is a recognized independent risk factor for major morbidity and mortality in cardiac surgery. The main interpretation is that low levels of HCT on CPB result in a poor oxygen delivery and dysoxia of end organs. Hyperlactatemia (HL) is a marker of dysoxic metabolism, and is associated with bad outcomes in cardiac surgery. This study explores the relationship between nadir HCT on CPB and early postoperative HL. DESIGN: Retrospective study on 3,851 consecutive patients. MEASUREMENTS AND MAIN RESULTS: Nadir HCT on CPB and other potential confounders were explored for association with blood lactate levels at the arrival in the Intensive Care Unit (ICU), and with the presence of moderate (2.1 - 6.0 mMol/L) or severe (> 6.0 mMol/L) HL. Nadir HCT on CPB demonstrated a significant negative association with blood lactate levels at the arrival in the ICU. After adjustment for the other confounders, the nadir HCT on CPB remained independently associated with moderate (odds ratio 0.96, 95% confidence interval 0.94-0.99) and severe HL (odds ratio 0.91, 95% confidence interval 0.86-0.97). Moderate and severe HL were significantly associated with increased morbidity and mortality. CONCLUSIONS: Hemodilution on CPB is an independent determinant of HL. This association, more evident for severe HL, strengthens the hypothesis that a poor oxygen delivery on CPB with consequent organ ischemia is the mechanism leading to hemodilution-associated bad outcomes.

Acute Kidney Injury and Hemodilution During Cardiopulmonary Bypass: A Changing Scenario.

BACKGROUND: Severe hemodilution during cardiopulmonary bypass (CPB) is a risk factor for acute kidney injury (AKI) after heart operations. Many improvements to CPB technology have been proposed during the past decade to limit the hemodilution-related AKI risk. The present study is a retrospective analysis of the relationship between hemodilution during CPB and AKI in cardiac operations in the setting of different interventions applied over 14 years. METHODS: We retrospectively analyzed 16,790 consecutive patients undergoing heart operations from 2000 to 2013. Various risk factors for AKI were collected and analyzed, together with a number of interventions as possible modifiers of the relationship between a nadir hematocrit (HCT) value during CPB and AKI. RESULTS: The relationship between the nadir HCT value during CPB and AKI was confirmed in a multivariable analysis, with the relative risk of AKI increasing by 7% per percentage point of decrease of the nadir HCT value during CPB. The relative risk of AKI decreased by 8% per year of observation (p = 0.001) despite a significantly increased risk of AKI (p = 0.001). A sensitivity analysis based on differences before and after different interventions demonstrated a beneficial effect of the application of goal-directed perfusion (aimed at preserving oxygen delivery during CPB), with a reduction in the AKI rate from 5.8% to 3.1% (p = 0.001). A policy restricting angiographic examination on the day of operation was also useful (reduction of AKI rate from 4.8% to 3.7%; p = 0.029). CONCLUSIONS: A bundle of interventions mainly aimed at limiting the renal impact of hemodilution during CPB is effective in reducing the AKI rate.