A Randomized Trial of Intravenous Amino Acids for Kidney Protection.

BACKGROUND: Acute kidney injury (AKI) is a serious and common complication of cardiac surgery, for which reduced kidney perfusion is a key contributing factor. Intravenous amino acids increase kidney perfusion and recruit renal functional reserve. However, the efficacy of amino acids in reducing the occurrence of AKI after cardiac surgery is uncertain. METHODS: In a multinational, double-blind trial, we randomly assigned adult patients who were scheduled to undergo cardiac surgery with cardiopulmonary bypass to receive an intravenous infusion of either a balanced mixture of amino acids, at a dose of 2 g per kilogram of ideal body weight per day, or placebo (Ringer's solution) for up to 3 days. The primary outcome was the occurrence of AKI, defined according to the Kidney Disease: Improving Global Outcomes creatinine criteria. Secondary outcomes included the severity of AKI, the use and duration of kidney-replacement therapy, and all-cause 30-day mortality. RESULTS: We recruited 3511 patients at 22 centers in three countries and assigned 1759 patients to the amino acid group and 1752 to the placebo group. AKI occurred in 474 patients (26.9%) in the amino acid group and in 555 (31.7%) in the placebo group (relative risk, 0.85; 95% confidence interval [CI], 0.77 to 0.94; P = 0.002). Stage 3 AKI occurred in 29 patients (1.6%) and 52 patients (3.0%), respectively (relative risk, 0.56; 95% CI, 0.35 to 0.87). Kidney-replacement therapy was used in 24 patients (1.4%) in the amino acid group and in 33 patients (1.9%) in the placebo group. There were no substantial differences between the two groups in other secondary outcomes or in adverse events. CONCLUSIONS: Among adult patients undergoing cardiac surgery, infusion of amino acids reduced the occurrence of AKI. (Funded by the Italian Ministry of Health; PROTECTION ClinicalTrials.gov number, NCT03709264.).

Extracorporeal Membrane Oxygenation Without Invasive Ventilation for Respiratory Failure in Adults: A Systematic Review.

OBJECTIVES: Extracorporeal membrane oxygenation (ECMO) is an advanced treatment for acute severe respiratory failure. Patients on ECMO are frequently maintained sedated and immobilized until weaning from ECMO, first, and then from mechanical ventilation. Avoidance of sedation and invasive ventilation during ECMO may have potential advantages. We performed a systematic literature review to assess efficacy and safety of awake ECMO without invasive ventilation in patients with respiratory failure. DATA SOURCES: PubMed, Web of Science, and Scopus were searched for studies reporting outcome of awake ECMO for adult patients with respiratory failure. STUDY SELECTION: We included all studies reporting outcome of awake ECMO in patients with respiratory failure. Studies on ECMO for cardiovascular failure, cardiac arrest, or perioperative support and studies on pediatric patients were excluded. Two investigators independently screened and selected studies for inclusion. DATA EXTRACTION: Two investigators abstracted data on study characteristics, rate of awake ECMO failure, and mortality. Primary outcome was rate of awake ECMO failure (need for intubation). Pooled estimates with corresponding 95% CIs were calculated. Subgroup analyses by setting were performed. DATA SYNTHESIS: A total of 57 studies (28 case reports) included data from 467 awake ECMO patients. The subgroup of patients with acute respiratory distress syndrome showed a pooled estimate for awake ECMO failure of 39.3% (95% CI, 24.0-54.7%), while in patients bridged to lung transplantation, pooled estimate was 23.4% (95% CI, 13.3-33.5%). Longest follow-up mortality was 121 of 439 (pooled estimate, 28%; 95% CI, 22.3-33.6%). Mortality in patients who failed awake ECMO strategy was 43 of 74 (pooled estimate, 57.2%; 95% CI, 40.2-74.3%). Two cases of cannula self-removal were reported. CONCLUSIONS: Awake ECMO is feasible in selected patients, although the effect on outcome remains to be demonstrated. Mortality is almost 60% in patients who failed awake ECMO strategy.

Coagulation Derangements in Patients With Refractory Cardiac Arrest Treated With Extracorporeal Cardiopulmonary Resuscitation.

OBJECTIVE: Extracorporeal cardiopulmonary resuscitation (eCPR) with venoarterial extracorporeal membrane oxygenation (VA-ECMO) is gaining importance as a rescue therapy for refractory cardiac arrest. VA-ECMO, especially in the setting of eCPR, is plagued by hemorrhagic and thromboembolic complications. The authors' aims were to describe the coagulation profile in refractory cardiac arrest and assess its prognostic role. DESIGN: Single-center retrospective study. SETTING: Cardiac surgical intensive care unit of a university hospital. PARTICIPANTS: One hundred eighty-eight patients treated with eCPR for intra-hospital and out-of-hospital refractory cardiac arrest, between 2008 and 2017. INTERVENTIONS: The authors retrospectively analyzed data from the first blood sample drawn during cannulation for VA-ECMO to understand the association of coagulation parameters with survival to hospital discharge, number of blood components transfused, anticoagulation therapy, serum lactate levels, no-flow time, and low-flow time. MEASUREMENTS AND MAIN RESULTS: Platelet count was 126 ± 79 × 109/L and in 17% of the population it was lower than 50 × 109/L, prothrombin time was 3.22 ± 4.01, activated partial thromboplastin time was 117 ± 78 seconds, fibrinogen was 186 ± 148 mg/dL, antithrombin was 47 ± 16%, and D-dimer was ≥2-fold the normal upper limit in 95% of patients. Fifty percent of patients had a disseminated intravascular coagulation (DIC) score ≥6 (52% among out-of-hospital cardiac arrest, 33% among in-hospital cardiac arrest), according to the criteria of the Japanese Society on Thrombosis and Hemostasis (2016). The median DIC score was 5.5 points (interquartile range 4-8), significantly different between survivors and nonsurvivors (4 [3-6] v 6 [4-8], p = 0.007). Every DIC score point contributed to the mortality risk (OR 1.34, 95% CI 1.09-1.67, p = 0.006). Patients with overt DIC less frequently received anticoagulants (28.6% v 55.9%, p = 0.002), started anticoagulant therapy later (12 [10-23] v 8.5 [5-12] hours, p = 0.045), and received a larger quantity of blood products (11 [4-23] v 3 [0-8.5] units, p < 0.0001). CONCLUSION: Coagulation derangements are frequent in patients with refractory cardiac arrest and have important consequences for eCPR management for anticoagulant therapy and blood product transfusion. The presence of DIC diagnostic criteria should be considered among the prognostic factors in this population of patients.

Esmolol before cardioplegia and as cardioplegia adjuvant reduces cardiac troponin release after cardiac surgery. A randomized trial.

BACKGROUND: Cardioplegic solutions are the standard in myocardial protection during cardiac surgery, since they interrupt the electro-mechanical activity of the heart and protect it from ischemia during aortic cross-clamping. Nevertheless, myocardial damage has a strong clinical impact. We tested the hypothesis that the short-acting beta-blocker esmolol, given immediately before cardiopulmonary bypass and as a cardioplegia additive, would provide an extra protection to myocardial tissue during cardiopulmonary bypass by virtually reducing myocardial activity and, therefore, oxygen consumption to zero. MATERIALS AND METHODS: This was a single-centre, double-blind, placebo-controlled, parallel-group phase IV trial. Adult patients undergoing elective valvular and non-valvular cardiac surgery with end diastolic diameter >60 mm and ejection fraction <50% were enrolled. Patients were randomly assigned to receive either esmolol, 1 mg/kg before aortic cross-clamping and 2 mg/kg with Custodiol® crystalloid cardioplegia or equivolume placebo. The primary end-point was peak postoperative troponin T concentration. Troponin was measured at Intensive Care Unit arrival and at 4, 24 and 48 hours. Secondary endpoints included ventricular fibrillation after cardioplegic arrest, need for inotropic support and intensive care unit and hospital stay. RESULTS: We found a reduction in peak postoperative troponin T, from 1195 ng/l (690-2730) in the placebo group to 640 ng/l (544-1174) in the esmolol group (p=0.029) with no differences in Intensive Care Unit stay [3 days (1-6) in the placebo group and 3 days (2-5) in the esmolol group] and hospital stay [7 days (6-10) in the placebo group and 7 days (6-12) in the esmolol group]. Troponin peak occurred at 24 hours for 12 patients (26%) and at 4 hours for the others (74%). There were no differences in other secondary end-points. CONCLUSIONS: Adding esmolol to the cardioplegia in high-risk patients undergoing elective cardiac surgery reduces peak postoperative troponin levels. Further investigation is necessary to assess esmolol effects on major clinical outcomes.

Cardiac surgery in 260 octogenarians: a case series.

BACKGROUND: The elderly undergo cardiac surgery more and more frequently, often present multiple comorbidities, assume chronic therapies, and present a unique physiology. Aim of our study was to analyze the experience of a referral cardiac surgery center with all types of cardiac surgery interventions performed in patients ≥80 years old over a six years' period. METHODS: A retrospective observational study performed in a university hospital. 260 patients were included in the study (3.5% of the patients undergoing cardiac surgery in the study period). RESULTS: Mean age was 82 ± 1.8 years. Eighty-five percent of patients underwent elective surgery, 15% unplanned surgery and 4.2% redo surgery. Intervention for aortic valve pathology and coronary artery bypass grafting were performed in 51% and 46% of the patients, respectively. Interventions involving the mitral valve were the 26% of the total, those on the tricuspid valve were 13% and those on the ascending aortic arch the 9.6%. Postoperative low output syndrome was identified in 44 patients (17%). Mortality was 3.9% and most of the patients (91%) were discharged from hospital in good clinical conditions. Hospital mortality was lower in planned vs unplanned surgery: 3.8% vs 14% respectively. Chronic obstructive pulmonary disease (OR 9.106, CI 2.275 - 36.450) was the unique independent predictor of mortality. CONCLUSIONS: Clinicians should be aware that cardiac surgery can be safely performed at all ages, that risk stratification is mandatory and that hemodynamic treatment to avoid complications is expected.

A comparison of the femoral and radial crossover techniques for vascular access management in transcatheter aortic valve implantation: the Milan experience.

OBJECTIVE: To compare radial and femoral crossover techniques (CT) for vascular access management in transcatheter aortic valve implantation (TAVI). BACKGROUND: Femoral crossover for controlled angiography and balloon inflation of the therapeutic access site to facilitate safe vascular closure is beneficial but technically challenging in patients with complex femoral anatomy. An alternative approach should be available. METHODS: Between June 2011 and March 2012, 41 transfemoral TAVI patients receiving the femoral CT were compared to 46 transfemoral TAVI patients receiving the radial CT. Outcomes were 30-day valve academic research consortium (VARC) endpoints. RESULTS: Patients undergoing the radial CT received higher median contrast volumes (150 interquartile range [IQR]: 105-180 vs. 111 IQR: 90-139 ml; P = 0.025) but procedural radiation dose and fluoroscopy times were comparable. Thirty day all cause and cardiovascular death were similar between radial and femoral CT groups (respectively 2.4% vs. 7.9%, P = 0.258 and 0% vs. 7.9%, P = 0.063). There were no differences in major vascular complications (4.3% vs. 7.3%, P = 0.553), life threatening or major bleeding events (respectively 9.1% vs. 19.5%, P = 0.168 and 13.6% vs. 22%, P = 0.315). CONCLUSION: In TAVI cases with unfavorable contralateral femoral anatomy, radial CT for vascular access management is a reasonable alternative to the femoral CT.

Do patients undergoing MitraClip implantation require routine ICU admission?

OBJECTIVES: Because of its reduced invasiveness, MitraClip (Abbott Vascular, Menlo Park, CA) therapy usually is reserved for patients with extreme left ventricular dysfunction or severe comorbidity contraindicating surgery. The appropriate post-procedural care in this high-risk population is yet to be defined. In this study, the postoperative course of such patients is reported, focusing on early complications and need for intensive care unit (ICU) management. DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis of patients with severe mitral regurgitation undergoing transcatheter mitral valve repair with the MitraClip system in the authors institution was performed. INTERVENTIONS: One hundred thirty patients underwent MitraClip implantation between 2008 and 2012. At the end of the procedure, all patients were admitted to the ICU. MEASUREMENTS AND MAIN RESULTS: Median ICU stay was 0.98 (0.82-1.87) days. Median mechanical ventilation time was 9.5 (6.8-14.1) hours. One hundred one patients (78%) required inotropic support and 13 patients (10%) suffered cardiogenic shock and required intra-aortic balloon pump support. No patient died during the procedure, but 3 patients died in the ICU. Three postoperative course profiles were identified: Fast-track, overnight stay, and critical illness. Twenty-four patients (18.5%) had an uneventful postoperative course, 89 patients (68.5%) suffered minor complications, and 17 patients (13.1%) required intensive care management and organ support. Preoperative serum creatinine (odds ratio [OR] 1.8; p = 0.014), cardiogenic shock (OR 34,8; p = 0.002), ventricular tachycardia (OR 2.8; p = 0.03), and intra procedural inotropes (OR 4; p = 0.001) were correlated with a complicated postoperative course. CONCLUSIONS: A large number of patients undergoing MitraClip could be managed with a fast-track ICU course; however, it still is difficult to predict the postoperative course based on preoperative characteristics.

Extracorporeal cardiopulmonary resuscitation for refractory out-of-hospital cardiac arrest: 10-year experience in a metropolitan cardiac arrest centre in Milan, Italy.

Introduction: Growing evidence supports extracorporeal cardiopulmonary resuscitation (ECPR) for refractory out-of-hospital cardiac arrest (OHCA) patients, especially in experienced centres. We present characteristics, treatments, and outcomes of patients treated with ECPR in a high-volume cardiac arrest centre in the metropolitan area of Milan, Italy and determine prognostic factors. Methods: Refractory OHCA patients treated with ECPR between 2013 and 2022 at IRCCS San Raffaele Scientific Institute in Milan had survival and neurological outcome assessed at hospital discharge. Results: Out of 307 consecutive OHCA patients treated with ECPR (95% witnessed, 66% shockable, low-flow 70 [IQR 58-81] minutes), 17% survived and 9.4% had favourable neurological outcome. Survival and favourable neurological outcome increased to 51% (OR = 8.7; 95% CI, 4.3-18) and 28% (OR = 6.3; 95% CI, 2.8-14) when initial rhythm was shockable and low-flow (time between CPR initiation and ROSC or ECMO flow) ≤60 minutes and decreased to 9.5% and 6.3% when low-flow exceeded 60 minutes (72% of patients). At multivariable analysis, shockable rhythm (aOR for survival = 2.39; 95% CI, 1.04-5.48), shorter low-flow (aOR = 0.95; 95% CI, 0.94-0.97), intermittent ROSC (aOR = 2.5; 95% CI, 1.2-5.6), and signs of life (aOR = 3.7; 95% CI, 1.5-8.7) were associated with better outcomes. Survival reached 10% after treating 104 patients (p for trend <0.001). Conclusions: Patients with initial shockable rhythm, intermittent ROSC, signs of life, and low-flow ≤60 minutes had higher success of ECPR for refractory OHCA. Favourable outcomes were possible beyond 60 minutes of low-flow, especially with concomitant favourable prognostic factors. Outcomes improved as the case-volume increased, supporting treatment in high-volume cardiac arrest centres.

Transcatheter vs surgical aortic valve replacement in intermediate-surgical-risk patients with aortic stenosis: a propensity score-matched case-control study.

BACKGROUND: Limited real-world data comparing outcomes after transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in intermediate-surgical-risk patients with aortic stenosis are available. METHODS: We identified 182 consecutive patients who underwent TAVR via the transfemoral (TF) route (November 2007-February 2011) and 111 moderate-to-high-risk historical case controls undergoing SAVR (August 2003-July 2008). Using propensity score matching based on clinical characteristics and surgical risk scores, we compared clinical outcomes in 111 matched patients. Valve Academic Research Consortium definitions were applied for end point adjudication. RESULTS: Baseline clinical characteristics, in particular Logistic European System for Cardiac Operative Risk Evaluation (23.2 ± 15.1 vs 24.4 ± 13.4) and Society of Thoracic Surgeons score (4.6 ± 2.3 vs 4.6 ± 2.6), were well matched between groups. Transfemoral TAVR was associated with more vascular complications (33.3% vs 0.9%, P < .001). On the other hand, acute kidney injury was more frequent after SAVR (8.1% vs 26.1%, P < .001). The rates of all-cause mortality in both TF-TAVR and SAVR groups was1.8% at 30 days (P = 1.00) and 6.4% and 8.1%, respectively, at 1 year (P = .80). At 1 year, the rate of cerebrovascular events was similar in the 2 groups (4.6% vs 9.1%, P = .19). CONCLUSIONS: In this real-world cohort of intermediate-surgical-risk patients with aortic stenosis, TF-TAVR and SAVR were associated with similar mortality rates during follow-up but with a different spectrum of periprocedural complications. Furthermore, the survival rate after TF-TAVR in this group of elderly patients with intermediate Society of Thoracic Surgeons score was encouraging.

Intravenous amino acid therapy for kidney protection in cardiac surgery a protocol for a multi-centre randomized blinded placebo controlled clinical trial. The PROTECTION trial.

BACKGROUND: Postoperative acute kidney injury (AKI) is frequent in cardiac surgery patients. Its pathophysiology is complex and involves decreased renal perfusion. Preliminary clinical evidence in critically ill patients shows that amino acids infusion increases renal blood flow and may decrease the incidence and severity of AKI. We designed a study to evaluate the effectiveness of perioperative continuous infusion of amino acids in decreasing AKI. METHODS: This is a phase III, multi-center, randomized, double-blind, placebo-controlled trial. Adults undergoing cardiac surgery with cardiopulmonary bypass (CPB) are included. Patients are randomly assigned to receive either continuous infusion of a balanced mixture of amino acids in a dose of 2 g/kg ideal body weight/day or placebo (balanced crystalloid solution) from the operating room up to start of renal replacement therapy (RRT), or ICU discharge, or 72 h after the first dose. The primary outcome is the incidence of AKI during hospital stay defined by KDIGO (Kidney Disease: Improving Global Outcomes). Secondary outcomes include the need for, and duration of, RRT, mechanical ventilation; ICU and hospital length of stay; all-cause mortality at ICU, hospital discharge, 30, 90, and 180 days after randomization; quality of life at 180 days. Data will be analyzed in 3500 patients on an intention-to-treat basis. DISCUSSION: The trial is ongoing and currently recruiting. It will be one of the first randomized controlled studies to assess the relationship between amino acids use and kidney injury in cardiac surgery. If our hypothesis is confirmed, this practice could reduce morbidity in the studied population. STUDY REGISTRATION: This trial was registered on ClinicalTrials.gov with the trial identification NCT03709264 in October 2018.

Anesthetic management of transcatheter aortic valve implantation with transaxillary approach.

OBJECTIVE: To describe the anesthetic management of transcatheter aortic valve implantation (TAVI) with the transaxillary approach. DESIGN: An observational cohort study. SETTING: Two university hospitals. PARTICIPANTS: Twenty-two patients with severe aortic stenosis (± regurgitation) at high risk for surgical valve replacement, with contraindications for transfemoral TAVI (81 ± 4.9 years; logistic EuroSCORE, 27% ± 16.9%). INTERVENTION: General anesthesia or local anesthesia plus sedation followed by postoperative care. MEASUREMENTS AND MAIN RESULTS: Local anesthesia plus sedation and general anesthesia were used in 14 and 8 patients, respectively. Two patients undergoing local anesthesia were monitored with transesophageal echocardiography and supported with noninvasive mask ventilation during the procedure. Main complications included hemodynamic instability requiring inotropes (2 patients), severe postimplant aortic regurgitation requiring immediate second valve-in-valve implantation (1 patient), valve embolization requiring open-valve surgery (1 patient), subclavian artery dissection compromising the flow to a mammary artery graft (1 patient), ascending aortic dissection (1 patient), stroke (2 patients), and atrioventricular block requiring pacemaker implantation (3 patients). Four patients experienced an increased (baseline value × 1.5) postoperative serum creatinine. Five patients required red blood cell tranfusions (2 units). Intensive care unit stay and hospital stay were 6 (4-23) hours and 8 (8-9) days, respectively. All patients were alive 30 days after the procedure. The 6-month mortality was 9%. CONCLUSIONS: Transaxillary TAVI is feasible in high-risk patients with aortic stenosis and peripheral vasculopathy. Nevertheless, severe procedural complications are possible, and anesthesiologists should be prepared to assist in the management of these conditions.

Outcomes of out-of-hospital cardiac arrest in patients with SARS-CoV-2 infection: a systematic review and meta-analysis.

INTRODUCTION: Out-of-hospital cardiac arrests increased during the COVID-19 pandemic and a direct mechanism of cardiac arrest in infected patients was hypothesized. Therefore, we conducted a systematic review and meta-analysis to assess outcomes of SARS-CoV-2 patients with out-of-hospital cardiac arrest. METHODS: PubMed and EMBASE were searched up to April 05, 2021. We included studies comparing out-of-hospital cardiac arrests patients with suspected or confirmed SARS-CoV-2 infection versus noninfected patients. The primary outcome was survival at hospital discharge or at 30 days. Secondary outcomes included return of spontaneous circulation, cardiac arrest witnessed and occurring at home, bystander-initiated cardiopulmonary resuscitation, proportion of nonshockable rhythm and resuscitation attempted, and ambulance arrival time. RESULTS: In the ten included studies, 18% (1341/7545) of out-of-hospital cardiac arrests occurred in patients with SARS-CoV-2 infection. Patients with out-of-hospital cardiac arrest and SARS-CoV-2 infection had reduced rates of survival (16/856 [1.9%] vs. 153/2344 [6.5%]; odds ratio (OR) = 0.33; 95% confidence interval (CI), 0.17-0.65; P = 0.001; I2 = 28%) and return of spontaneous circulation (188/861 [22%] vs. 640/2403 [27%]; OR = 0.75; 95% CI, 0.65-0.86; P < 0.001; I2 = 0%) when compared to noninfected patients. Ambulance arrived later (15 ± 10 vs. 13 ± 7.5 min; mean difference = 1.64; 95% CI, 0.41-2.88; P = 0.009; I2 = 61%) and nonshockable rhythms (744/803 [93%] vs. 1828/2217 [82%]; OR = 2.79; 95% CI, 2.08-3.73; P < 0.001; I2 = 0%) occurred more frequently. SARS-CoV-2 positive patients suffered a cardiac arrest at home more frequently (1186/1263 [94%] vs. 3598/4055 [89%]; OR = 1.86; 95% CI, 1.45-2.40; P<0.001; I2 = 0%) but witnessed rate (486/890 [55%] vs. 1385/2475 [56%]; OR = 0.97; 95% CI, 0.82-1.14; P = 0.63; I2 = 0%) and bystander-initiated cardiopulmonary resuscitation rate (439/828 [53%] vs. 1164/2304 [51%]; OR = 0.95; 95% CI, 0.73-1.24; P = 0.70; I2 = 53%) were similar. CONCLUSIONS: One-fifth of out-of-hospital cardiac arrest patients had SARS-CoV-2 infection. These patients had low rates of return of spontaneous circulation and survival and were characterized by higher nonshockable rhythms but similar bystander-initiated cardiopulmonary resuscitation rate. REVIEW REGISTRATION: PROSPERO - CRD42021243540.

First experience with a ROTEM-enhanced transfusion algorithm in patients undergoing aortic arch replacement with frozen elephant trunk technique. A theranostic approach to patient blood management.

STUDY OBJECTIVE: To assess the effect of a rotational thromboelastometry (ROTEM)-enhanced transfusion algorithm with hemostatic agents on allogenic blood transfusion in patients undergoing frozen elephant trunk (FET) surgery. DESIGN: Retrospective observational study conducted in a tertiary-care center. SETTING: A tertiary care referral center for cardiac surgery. PATIENTS: All patients undergoing elective FET were included in the study. INTERVENTION: Until 2016, a protocol based on estimated blood losses and conventional coagulation tests was used. After, a ROTEM-enhanced transfusion protocol was adopted. MEASUREMENTS: The transfusion rate of each blood component was observed and reported. METHODS: Retrospective, observational study. MAIN RESULTS: Out of 40 consecutive patients, 19 underwent FET surgery with a conventional transfusion approach and 21 with a ROTEM-enhanced transfusion strategy. Considering the overall transfusion rate, the administration of fresh frozen plasma and platelets was significantly lower in the ROTEM compared to conventional group (1000 [0-2500] vs 0 [0-875] ml, p = 0.015 and 1 [1, 2] vs 0 [0-1], p = 0.016, respectively). ROTEM algorithm allowed to decrease the number of patients who required plasma and platelets transfusion of 31%. Furthermore, a 40% reduction in overall allogenic blood products was observed. Number of red blood cells administered, percentage of patients transfused with red blood cells, blood losses, reoperation for bleeding and mortality did not significantly differ between the two groups. At the multiple linear regression analysis only ROTEM algorithm was associated with a significant decrease in the number of plasma and platelets units administered intraoperatively, at 24 h, at the ICU discharge and overall. ROTEM algorithm allowed to save 1435 ml of plasma, 0.91 unit of platelets and overall transfusion cost of the 21% per patient. CONCLUSIONS: A ROTEM-enhanced transfusion strategy halved intraoperative transfusion in the setting of FET. Further studies are needed to confirm the magnitude of our findings on clinically relevant endpoints.

Routine Screening of Coronary Artery Disease With Computed Tomographic Coronary Angiography in Place of Invasive Coronary Angiography in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Coronary artery disease (CAD) screening is required before transcatheter aortic valve implantation (TAVR). Although invasive coronary angiography (CA) remains the gold standard for CAD assessment, computed tomographic CA (CTCA) could be a safe and effective noninvasive alternative for CAD screening in patients undergoing TAVR. METHODS AND RESULTS: From November 2007 to May 2013, all patients undergoing TAVR at our institution were included in the study cohort. CTCA was used as first-line imaging tool for CAD screening. Invasive CA was performed when any of the following were present: coronary anatomy at CTCA was not evaluable and presence of significant CAD at CTCA. The primary objective was to compare major adverse cardiovascular and cerebrovascular events at 30 days and 1 year between patients who performed CTCA as only screening test and those who performed CTCA and invasive CA. Of 491 patients treated with TAVR, 375 (76.3%) performed only CTCA, whereas 116 (21.7%) underwent also CA. No differences were present in crude major adverse cardiovascular and cerebrovascular event rates at 30 days and 1 year between the 2 groups. After multivariable adjustment, CTCA performed alone was not associated with higher risk of MACE at 1 year of follow-up (hazard ratio, 0.89; 95% confidence interval, 0.49-1.60; P=0.69). CONCLUSIONS: CTCA performed as a routine noninvasive imaging tool in patients undergoing TAVR seems safe and effective allowing, with a single test, acquisition of information on aortic annulus anatomy, peripheral access sites, and evaluation of coronary anatomy.

Effects of tranexamic acid on postoperative bleeding and related hematochemical variables in coronary surgery: Comparison between on-pump and off-pump techniques.

OBJECTIVES: Bleeding and inflammation are major complications of extracorporeal circulation. Off-pump coronary artery bypass grafting may reduce the rate of complications, but it can only be applied in selected cases. Pilot studies have shown a potential benefit from the use of antifibrinolytic drugs, but efficacy in randomized double-blind studies evaluating off- and on-pump coronary artery bypass grafting has not been proved. METHODS: We enrolled 102 patients scheduled for on-pump (n = 51) or off-pump (n = 51) coronary artery bypass grafting. Patients were separately double-blind randomly assigned to treatment with tranexamic acid (1 g as 20-minute bolus before skin incision, followed by continuous infusion of 400 mg/h, with 500 mg added to priming in patients undergoing on-pump coronary artery bypass grafting) or placebo (saline solution of equivalent volume). Bleeding in the first 24 postoperative hours was the primary outcome. Requirement for allogeneic transfusions, thrombotic complications, outcomes, and monitoring of coagulation, fibrinolysis, and inflammation were also recorded. RESULTS: Tranexamic acid reduced total postoperative bleeding by 43% in patients undergoing on-pump coronary artery bypass grafting and by 27% in those undergoing off-pump coronary artery bypass grafting (P <.0001), with 80% reduction in bleeding exceeding 600 mL (P <.001), 58% reduction in the requirement for all allogeneic transfusions (P =.07), and no apparent effect on thrombotic complications or outcome. This was associated with a reduction in plasma D-dimer levels (P <.0001), to a greater degree in patients undergoing on-pump coronary artery bypass grafting (P <.0001), and interleukin 6 levels (P <.0001), to a greater degree in patients undergoing off-pump coronary artery bypass grafting (P <.001). CONCLUSIONS: By affecting fibrinolysis, tranexamic acid significantly reduces bleeding both in off- and on-pump coronary artery bypass grafting and may modulate inflammation in these surgical settings.

Long-term outcome and quality of life of patients requiring prolonged mechanical ventilation after cardiac surgery.

OBJECTIVES: To study the long-term survival and quality of life of patients with a complicated post-operative course after cardiac surgery requiring prolonged (>or=7 days) mechanical ventilation (MV), since they represent a heavy burden on hospital resources and their outcome has never been adequately evaluated. METHODS: Out of 4827 consecutive cardiac surgical patients, 148 (3%) required prolonged post-operative MV: their hospital course was analysed and factors affecting prolonged MV and mortality were identified using multivariate analysis. Long-term survival was assessed using Cox proportional hazard method. Long-term (36+/-12 months) follow-up information was collected and quality of life was assessed by an ad hoc questionnaire. RESULTS: Overall mortality in the study group was 45.3 versus 2% in the control population (P<0.0001). Predictors of death in the prolonged MV group were age (odds ratio, OR 1.049) and diabetes (OR 3.459). Long-term survival was significantly worse in those patients who were extubated after 21 days: 88.9 versus 70.9% at 1 year (P=0.03) and 80.9 versus 64.5% at 5 years (P=0.05). Mild or no limitation in daily living was referred by 69% of the survivors. CONCLUSIONS: The hospital mortality of patients requiring prolonged MV is high. The long-term survival of patients who are weaned from MV after 21 days is significantly lower. The great majority of the survivors can enjoy a good quality of life.

Usefulness of baseline activated clotting time-guided heparin administration in reducing bleeding events during transfemoral transcatheter aortic valve implantation.

OBJECTIVES: This study sought to evaluate the impact of baseline activated clotting time (ACT)-guided heparin administration on major bleeding after transfemoral transcatheter aortic valve implantation (TAVI). BACKGROUND: Bleeding after TAVI is frequent and associated with unfavorable prognosis. Proper intraprocedural heparin dose administration may reduce the risk of potential overdosing in this frail study group. METHODS: Of the patients who underwent transfemoral TAVI in our center from November 1, 2007 to June 31, 2012, 362 were retrospectively analyzed. Because abnormally high baseline ACT values were noted, heparin was administered at the operator's discretion, according to baseline ACT (ACT-guided, n = 174) or patient's body weight (non-ACT-guided, n = 188). The primary study objective was 30-day major bleeding as defined by the Valve Academic Research Consortium criteria. Secondary objectives were any life-threatening, and minor bleeding, and other Valve Academic Research Consortium outcomes at 30 days. RESULTS: Bleeding occurred in 167 (46.1%) patients; of these, 76 (21.0%) had major bleeding. The ACT-guided group had a significantly lower occurrence of major (7.5% vs. 33.5%, p < 0.001), life-threatening (12.1% vs. 20.2%, p = 0.04), and any bleeding (25.9% vs. 64.9%, p < 0.001). Conversely, no differences were noted in the other study objectives. After adjustment for potential confounders, the protective odds ratio for ACT-guided therapy on major bleeding was 6.4 (95% confidence interval: 2.3 to 17.9; p < 0.001) at 30 days. CONCLUSIONS: In our experience, heparin administration according to baseline ACT was correlated with a significantly lower occurrence of major bleeding in transfemoral TAVI. This strategy might be a useful tool in reducing bleeding in this high-risk study group.

Impact of mean platelet volume on combined safety endpoint and vascular and bleeding complications following percutaneous transfemoral transcatheter aortic valve implantation.

BACKGROUND: Vascular and bleeding complications remain important complications in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI). Platelets play an important role in bleeding events. Mean platelet volume (MPV) is an indicator of platelet activation. The objective of this study was to assess whether low MPV is an indicator of major vascular and bleeding complications following TF-TAVI. METHODS: A retrospective cohort study of 330 subjects undergoing TF-TAVI implantation was performed. The primary study endpoint was the occurrence of combined safety endpoint (CSEP); secondary endpoints included major vascular complications and life-threatening bleeding. Endpoints were defined according to Valve Academic Research Consortium 2. RESULTS: The CSEP at 30 days was reached in 30.9%; major vascular complications were observed in 14.9% while life-threatening bleeding occurred in 20.6%. Logistic Euroscore and MPV were independent predictors of CSEP. Predictors of vascular complications were female sex, previous myocardial infarction, red blood cell distribution width (RDW), and MPV while predictors of life-threatening bleeding were peripheral arterial disease, RDW, and MPV. CONCLUSION: A low baseline MPV was shown for the first time to be a significant predictor of CSEP, major vascular complications, and life-threatening bleeding following TF-TAVI.

Anaesthetic management of transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is an emergent technique for high-risk patients with aortic stenosis. TAVI poses significant challenges about its management because of the procedure itself and the population who undergo the implantation. Two devices are currently available and marketed in Europe and several other technologies are being developed. The retrograde transfemoral approach is the most popular procedure; nevertheless, it may not be feasible in patients with significant aortic or ileo-femoral arterial disease. Alternatives include a transaxillary approach, transapical approach, open surgical access to the retroperitoneal iliac artery and the ascending aorta. A complementary approach using both devices and alternative routes tailored to the anatomy and the comorbidities of the single patient is a main component for the successful implementation of a TAVI program. Anaesthetic strategies vary in different centers. Local anaesthesia or general anaesthesia are both valid alternatives and can be applied according to the patient's characteristics and procedural instances. General anaesthesia offers many advantages, mainly regarding the possibility of an early diagnosis and treatment of possible complications through the use of transesophageal echocardiography. However, after the initial experiences, many groups began to employ, routinely, sedation plus local anaesthesia for TAVI, and their procedural and periprocedural success demonstrates that it is feasible. TAVI is burdened with potential important complications: vascular injuries, arrhythmias, renal impairment, neurological complications, cardiac tamponade, prosthesis malpositioning and embolization and left main coronary artery occlusion. The aim of this work is to review the anaesthetic management of TAVI based on the available literature.