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The aim of this study was to analyze procedural and postprocedural outcomes of patients aged ≥80 years treated by transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) as enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) Study. TAVI is offered to patients with aortic stenosis judged inoperable or at high surgical risk. Nevertheless, it is common clinical practice to treat elderly (≥80 years) patients by TAVI regardless of surgical risk for traditional SAVR. OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. Information on demographic characteristics, health status before intervention, therapeutic approach, and intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on midterm to long-term outcomes. We reviewed baseline and procedural data of patients aged ≥80 years, looking for different early and late outcome after TAVI or SAVR. Patients treated by TAVI were sicker than SAVR because of higher rate of co-morbidities, advanced illness, frailty, and Logistic EuroSCORE. After propensity matching, early and midterm mortality were comparable between the 2 groups. However, patients treated by TAVI had higher rate of vascular complications (6.0% vs 0.5%; p0.0001), permanent pacemaker implantation (13.4% vs 3.7%; p0.0001), and paravalvular leak (8.9% vs 2.4%; p0.0001). Patients who underwent SAVR had more frequent bleedings needing transfusion (63.2% vs 34.5%; p0.0001) and acute kidney injury (9.6% vs 3.9%; p = 0.0010). In conclusion, patients aged ≥80 years treated by TAVI or SAVR had similar early and midterm mortality.

Objectives To describe results from our modified crossover technique for vascular access management during transcatheter aortic valve implantation (TAVI). Background Vascular access management remains a major cause of complications following TAVI due to the large bore sheaths required. Methods All suitable patients undergoing TAVI in our center, between June and August 2011, underwent our modified crossover technique, which enables the passage of a balloon through left radial access and inflation in the proximal iliac to allow percutaneous closure in a clean field. Results In total, 15 patients were included: the logistic EuroSCORE was 19.7 +/- 12.1% and STS score 5.7 +/- 5.6%. The mean therapeutic femoral access site diameter was 8.1 +/- 1.0 mm. Ten (66.7%) patients received Edwards SAPIEN XT (two using the new E-sheath) and five (33.3%) patients a Medtronic CoreValve ReValving System (R) device. The modified crossover technique was used successfully in all patients. There were three vascular complications occurring at the therapeutic access site: one rupture of the external iliac artery, one Prostar failure, and one pseudoaneurysm of the right common femoral artery. All complications were successfully treated percutaneously with covered stent implantation via access from the contralateral femoral artery. In view of the balloon inflation from the left radial artery, the complications could be treated in a clean field with minimal blood loss. Conclusions Our modified crossover technique using the left radial artery as the diagnostic site for balloon inflation appears a helpful adjunct in managing TAVI vascular access sites. (c) 2012 Wiley Periodicals, Inc.

Transcatheter aortic valve implantation (TAVI) is an alternative to surgicalaortic valve replacement in very high-risk patients with severe aortic stenosis. The present multicenter, retrospective study investigates the accuracy andcalibration properties of the EuroSCORE and the age, serum creatinine, andejection fraction (ACEF) score in selecting a population of patients to bereferred to TAVI. The study includes 1053 surgical and 211 transcatheterprocedures. The operative mortality rate within the surgical group was 2%. TheEuroSCORE and the ACEF score had similar levels of accuracy; the ACEF score waswell calibrated and the EuroSCORE overestimated the mortality risk. The observed mortality rate within the transcatheter group was 10.4%. Cut-off valuescorresponding to a mortality rate of 10% were 26 for the logistic EuroSCORE and2.5 for the ACEF score: both the EuroSCORE and the ACEF score may be used torefer patients to TAVI. However, they do not consider a number of 'extreme' risk conditions that may justify a transcatheter procedure even in absence of anoverall elevated risk score. These risk conditions should be included in aspecific risk model for referring patients for TAVI.

Background Inodilators are commonly used in critically ill patients, but their effect on survival has not been properly studied to date. The objective of this work was to conduct a network meta-analysis on the effects of inodilators on survival in adult cardiac surgery patients, and to compare and rank drugs that have not been adequately compared in head-to-head trials. Methods Relevant studies were independently searched in BioMedCentral, MEDLINE/PubMed, Embase, and the Cochrane Central Register of clinical trials (updated on May 1, 2014). The criteria for inclusion were: random allocation to treatment with at least one group receiving dobutamine, enoximone, levosimendan, or milrinone and at least another group receiving the above inodilators or placebo, performed in cardiac surgical patients. The endpoint was to identify differences in mortality at longest follow-up available. Results The 46 included trials were published between 1995 and 2014 and randomised 2647 patients. The Bayesian network meta-analysis found that only the use of levosimendan was associated with a decrease in mortality when compared with placebo (posterior mean of OR=0.48, 95% CrI 0.28 to 0.80). The posterior distribution of the probability for each inodilator to be the best and the worst drug showed that levosimendan is the best agent to improve survival after cardiac surgery. The sensitivity analyses performed did not produce different interpretative result. Conclusion Levosimendan seems to be the most efficacious inodilator to improve survival in cardiac surgery.

Aims: The aim of this study was to report the feasibility and the preliminary outcomes after transcatheter aortic valve implantation (TAVI) in the frail and unique high-risk population of patients with systemic sclerosis (SSc) and severe aortic stenosis (AS). Methods and results: All patients with SSc and severe AS treated with TAVI between November 2007 and June 2013 in our centre were included in the current study. Outcomes were assessed using the Valve Academic Research Consortium 2 (VARC-2) definitions. Of 526 surgical high-risk patients treated in the study period, only six had SSc (1.1%). All SSc patients underwent transfemoral TAVI under conscious sedation. The procedure was successfully performed in all patients. There was one case of a major vascular complication. During a median follow-up time of 550 days (interquartile range 390-1,009 days), five of the six patients were alive, free from any complications and with an NYHA Class I or II. One patient died at 670 days from a stroke of unknown aetiology. Conclusions: The present case series suggests that the TAVI procedure is feasible in patients with SSc and severe AS. OI Giustino, Gennaro/0000-0002-5400-9516

OBJECTIVE: Anticoagulation with unfractionated heparin (UFH) in critically ill cardiac surgery patients has several limitations, including the risk of heparin-induced thrombocytopenia. The use of a direct thrombin inhibitor, such as bivalirudin, might either treat this complication or completely eliminate it. The aim of the present study was to analyze the use of bivalirudin in this setting, as either a secondary drug switching from heparin or as the primary anticoagulant, and to evaluate clinical outcomes.DESIGN: Propensity-matching retrospective analysis.SETTING: A cardiac surgery intensive care unit.PARTICIPANTS: One hundred propensity-matched patients who received heparin or bivalirudin.INTERVENTIONS: Bivalirudin was administered as a first-line or second-line drug after heparin discontinuation in case of thrombocytopenia and suspicion of heparin-induced thrombocytopenia. Twenty-six patients (52%) received bivalirudin as a primary anticoagulant, while 24 patients (48%) received bivalirudin after switching from heparin.MEASUREMENTS AND MAIN RESULTS: Bivalirudin treatment was associated with a reduction of major bleeding (p = 0.05) compared with the control group. Interestingly, in an intention-to-treat analysis, patients receiving primary bivalirudin showed significant reductions in minor bleeding (p = 0.04), and mortality (p = 0.01) compared with the secondary bivalirudin group and, similarly, compared with the rest of the study population (UFH and secondary bivalirudin patients, p = 0.01 and p = 0.05, respectively). Predictors of hospital mortality by multivariate analysis included urgent admission (odds ratio [OR] = 2.7; 95 confidence interval [CI], 1.03-7.2; p = 0.04), ;septic shock (OR = 8.0; 95 CI, 2.26-28.7; p

Afterload mismatch, defined as acute impairment of left ventricular function after mitral surgery, is a major issue in patients with low ejection fraction and functional mitral regurgitation (FMR). Safety and efficacy of MitraClip therapy have been assessed in randomized trials, but limited data on its acute hemodynamic effects are available. This study aimed to investigate the incidence and prognostic role of afterload mismatch in patients affected by FMR treated with MitraClip therapy. We retrospectively analyzed patients affected by FMR and submitted to MitraClip therapy from October 2008 to December 2012. Patients were assigned to 2 groups according to the occurrence of the afterload mismatch: patients with afterload mismatch (AM+) and without afterload mismatch (AM-). Of 73 patients, 19 (26%) experienced afterload mismatch in the early postoperative period. Among preoperative variables, end-diastolic diameter (71 ± 8 vs 67 ± 7 mm, p = 0.02) and end-systolic diameter (57 ± 9 vs 53 ± 7 mm, p = 0.04) were both significantly larger in AM+ group. An increased incidence of right ventricular dysfunction (68% vs 31%, p = 0.049) and pulmonary hypertension (49 ± 10 vs 40 ± 10 mm Hg, p = 0.0009) was found in AM+ group. Before hospital discharge, left ventricular ejection fraction (LVEF) became similar in both groups (31 ± 9% vs 33 ± 11%, p = 0.65). Long-term survival was comparable between the 2 groups (p = 0.44). A low LVEF in the early postoperative period (LVEF

"OBJECTIVE: There are no large studies that investigate the effect of thoracic epidural anesthesia (TEA) combined with general anesthesia (GA) in patients undergoing valvular surgery. The authors hypothesized that TEA might improve clinically relevant endpoints in patients with primary mitral regurgitation.. . DESIGN: Propensity-matched study.. . SETTING: Cardiac surgery.. . PARTICIPANTS: Patients scheduled for mitral valve repair or replacement were studied.. . INTERVENTIONS: A propensity model was constructed to match 33 patients receiving TEA combined with GA with 33 patients receiving standard GA alone.. . MEASUREMENTS AND MAIN RESULTS: Overall, the TEA group suffered fewer adverse events than the GA group: 10 (30%) v 23 (10%) with p = 0.002. In particular, the TEA group had a lower incidence of pulmonary events, 6 (18%) v 15 (45%) with p = 0.02, and of cardiac events, 8 (24%) v 16 (49%) with p = 0.04. Median (interquartile) time on mechanical ventilation was reduced in the TEA group, 11 (9-15) v 17 (12-36) with p = 0.007.. . CONCLUSIONS: This propensity-matched study suggested that TEA might be advantageous in patients undergoing surgery for mitral regurgitation. "

Objective: Heparin-based anticoagulation for patients undergoing extracorporeal membrane oxygenation has many limitations, including a high risk of heparin-induced thrombocytopenia. However, little experience with other anticoagulants in these patients has been described. The aim of this study was to compare bivalirudin-based anticoagulation with heparin-based protocols in a population of patients treated with venovenous or venoarterial extracorporeal membrane oxygenation. Design: In this case-control study, 10 patients received bivalirudin (cases) and 10 heparin (controls). The target activated partial thromboplastin time (aPTT) was 45 to 60 seconds. Interventions: None. Measurements and Main Results: aPTT variations >20% of the previous value were much more frequent in patients treated with heparin than in patients receiving bivalirudin (52 v 24, p < 0.001). The number of corrections of the anticoagulant dose was higher in the heparin group compared with the bivalirudin group (58 v 51), although it did not reach statistical significance. Bleeding, thromboembolic complications, extracorporeal membrane oxygenation (ECMO) support duration, mortality, and the number of episodes of aPTT >80 seconds were not different between the 2 groups. A further analysis was performed in the bivalirudin group according to the presence of acute renal failure requiring continuous venovenous hemofiltration. The median bivalirudin dose in patients with or without hemofiltration was 0.041 (0.028-0.05) mg/kg/h and 0.028 (0-0.041) mg/kg/h, respectively (p = 0.2). Conclusions: Bivalirudin-based anticoagulation may represent a new method of anticoagulation for reducing thromboembolic and bleeding complications, which still jeopardize the application of extracorporeal membrane oxygenation. Moreover, bivalirudin is free from the risk of heparin-induced thrombocytopenia. Higher doses of bivalirudin may be needed in patients undergoing hemofiltration.

Aims Reoperation for bioprosthetic heart valve failure is associated with significant morbidity and mortality, particularly in high-risk patients. Transcatheter valve-in-valve (VIV) implantation may offer a less invasive alternative. The aim of this study was to report our initial experience with transcatheter VIV implantation to treat degenerated tissue valves. Methods and results VIV implantation with the Edwards SAPIEN transcatheter heart valve (THV; Edwards Lifesciences Inc, Irvine, CA, USA) was performed in 18 high-risk patients (STS 8.2±5.2%; logistic EuroSCORE 37.4±20.8%) with symptomatic bioprosthetic failure (17 aortic, one mitral). Valve Academic Research Consortium (VARC) definitions were applied for endpoint adjudication. Transfemoral access was the preferred vascular approach (16 patients, with the mitral VIV delivered anterogradely through the femoral vein; one transaxillary and one transapical). The majority (83%) of procedures were performed under local anaesthesia and sedation. Device success was achieved in all but one patient who had a final transaortic gradient ≥20mmHg. Acute kidney injury occurred in three patients (Stage 3 in 1), life-threatening or major bleeding in four patients, while major vascular complications occurred in one patient. Permanent pacemaker implantation was required in two patients. There were no deaths or neurological events at 30-day follow-up. At a median follow-up of 11 months (interquartile range 6-16), the mortality rate was 5.6% and all patients were in NYHA class II or lower. Conclusions Transcatheter implantation of the Edwards THV within a degenerated aortic bioprosthesis, performed predominantly via the transfemoral route, is feasible and associated with good periprocedural and clinical outcomes in high-risk surgical patients.

b w o t SURGICAL AORTIC VALVE replacement is the treatment of choice for aortic stenosis (AS).1 In a subset of elderly patients with declining overall health status or severe comorbidities, aortic valve replacement is considered too high risk and is contraindicated.2 Percutaneous aortic valve implantation (PAVI) is an emerging technique that is an alternative to surgical replacement in high-risk patients with AS. The goal of this procedure is to minimize the surgical stress, namely avoiding sternotomy, cardiopulmonary bypass and its related complications, and the potential risks associated with anesthesia induction, tracheal intubation, and mechanical ventilation.1-3 Anesthesia techniques for PAVI may vary according to the patient’s characteristics, comorbidities, and procedural circumstances. Most PAVI procedures are performed under general anesthesia, but local anesthesia also has been used.4-7 High-risk patients gain important advantages from such minimally invasive anesthetic techniques. When local anesthesia is used, a major problem is the patient’s need to maintain the supine position on the catheterization laboratory table, which is barely tolerated by an awake and orthopneic patient; in this situation, light sedation must be used. Sedative administration carries a risk of respiratory depression, whereas fluoroscopy equipment regularly limits access to the patient’s head to support ventilation once the procedure has started. Noninvasive positive-pressure ventilation (NIV) is a technique for delivering mechanical ventilation that increasingly is being used for acute and chronic conditions. It is defined as any form of ventilatory support applied without endotracheal intubation. This modality may avoid most of the complications of invasive mechanical ventilation while ensuring a similar degree of efficacy at the same time. NIV is one of the most important developments in respiratory intensive care over the past 15 years even outside the intensive care unit (ICU).8-10 Recently, everal studies have reported on the application of NIV for ntraoperative airway management in patients who are at high isk of undergoing mechanical ventilation and/or general aneshesia because of pulmonary disease (eg, chronic obstructive ulmonary disease or recurrent pneumothorax) and in patients uffering from acute respiratory failure.11-14 NIV has been used extensively in novel applications,15 in particular to assist ventilation during potentially risky procedures like bronchoscopy,16 gastrostomy tube placement,17 and transesophageal echocardiography.18 The use of NIV in 5 consecutive high-risk patients with pulmonary disease and orthopnea during PAVI to treat severe aortic valve stenosis is reported.

Objectives The aim of this study was to analyze the short-term outcomes after transcatheter aortic valve implantation with the Edwards Sapien THV (ESV), compared with the Sapien XT THV (SXT) (Edwards Lifesciences, Irvine, California). Background The SXT has been recently commercialized in Europe, but there are no studies analyzing the efficacy and safety of SXT, compared with ESV. Methods All consecutive patients (n = 120) who underwent transcatheter aortic valve implantation in our center via the transfemoral approach with either ESV (n = 66) or SXT (n = 54). Valve Academic Research Consortium endpoints were used. Results Mean age was 80 ± 8 years, and mean Logistic-European System for Cardiac Operative Risk Evaluation was 24.9 ± 17.0. The ilio-femoral artery minimal lumen diameter was smaller in patients treated with the SXT (7.27 ± 1.09 mm vs. 7.94 ± 1.08 mm, p = 0.002). Device success was high in both groups (96.3% vs. 92.4%, p = 0.45). Major vascular events were 3-fold lower in the SXT group (11.1% vs. 33.3%, relative risk: 0.40, 95% confidence interval: 0.28 to 0.57; p = 0.004). Life-threatening and major bleeding events were not significantly different between groups (18.5% vs. 27.3% and 35.2% vs. 40.9%, respectively). The SXT group had a lower 30-day Valve Academic Research Consortium combined safety endpoint (20.4% vs. 45.5%; relative risk: 0.44, 95% confidence interval: 0.24 to 0.80; p = 0.004). The 30-day mortality was 1.7% (n = 2). At 30 days, mean transaortic gradient was approximately 10 mm Hg in both groups and the aortic regurgitation was mild-to-moderate in 70.2% of SXT and 76.3% of ESV. Conclusions The new SXT valve has the same short-term performance as the ESV but seems to be associated with a lower risk of major vascular complications and thus has a broader clinical application.

Background The effect of anaesthesia on postoperative outcome is unclear. Cardioprotective properties of volatile anaesthetics have been demonstrated experimentally and in haemodynamically stable patients undergoing coronary artery bypass grafting. Their effects in patients undergoing high-risk cardiac surgery have not been reported. Methods We performed a multicentre, randomized, parallel group, controlled study among patients undergoing high-risk cardiac surgery (combined valvular and coronary surgery) in 2008–2011. One hundred subjects assigned to the treatment group received sevoflurane for anaesthesia maintenance, while 100 subjects assigned to the control group received propofol-based total i.v. anaesthesia. The primary outcome was a composite of death, prolonged intensive care unit (ICU) stay, or both. Thirty day and 1 yr follow-up, focused on mortality, was performed. Results All 200 subjects completed the follow-up and were included in efficacy analyses, conducted according to the intention-to-treat principle. Death, prolonged ICU stay, or both occurred in 36 out of 100 subjects (36%) in the propofol group and in 41 out of 100 subjects (41%) in the sevoflurane group; relative risk 1.14, 95% confidence interval 0.8–1.62; P=0.5. No difference was identified in postoperative cardiac troponin release [1.1 (0.7–2) compared with 1.2 (0.6–2.4) ng ml−1, P=0.6], 1 yr all-cause mortality [11/100 (11%) compared with 11/100 (11%), P=0.9], re-hospitalizations [20/89 (22.5%) compared with 11/89 (12.4%), P=0.075], and adverse cardiac events [10/89 (11.2%) compared with 9/89 (10.1%), P=0.8]. Conclusions There was no observed beneficial effect of sevoflurane on the composite endpoint of prolonged ICU stay, mortality, or both in patients undergoing high-risk cardiac surgery. Clinical trial registration ClinicalTrials.gov: identifier NCT00821262. Eudra CT (2008-001752-43).

Coronary obstruction (CO) is a rare but potentially fatal complication in patients undergoing transcatheter aortic valve replacement (TAVR). CO is most commonly caused by the displacement of a calcified native aortic valve leaflet toward the coronary ostium [(1)][1]. An 89-year-old woman underwent

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. (C) 2014 by the American College of Cardiology Foundation OI Giustino, Gennaro/0000-0002-5400-9516

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.

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. (Am Heart J 2012;164:910-7.)

Objective The authors conducted a review of randomized studies to show whether there are any increases or decreases in survival when using milrinone in patients undergoing cardiac surgery. Design A meta-analysis. Setting Hospitals. Participants Five hundred eighteen patients from 13 randomized trials. Interventions None. Measurements and Main Results BioMedCentral, PubMed EMBASE, the Cochrane central register of clinical trials, and conference proceedings were searched for randomized trials that compared milrinone versus placebo or any other control in the setting of cardiac surgery that reported data on mortality. Overall analysis showed that milrinone increased perioperative mortality (13/249 [5.2%] in the milrinone group v 6/269 [2.2%] in the control arm, odds ratio [OR] = 2.67 [1.05-6.79], p for effect = 0.04, p for heterogeneity = 0.23, I2 = 25% with 518 patients and 13 studies included). Subanalyses confirmed increased mortality with milrinone (9/84 deaths [10.7%] v 3/105 deaths [2.9%] with other drugs as control, OR = 4.19 [1.27-13.84], p = 0.02) with 189 patients and 5 studies included) but did not confirm a difference in mortality (4/165 [2.4%] in the milrinone group v 3/164 [1.8%] with placebo or nothing as control, OR = 1.27 [0.28-5.84], p = 0.76 with 329 patients and 8 studies included). Conclusions This analysis suggests that milrinone might increase mortality in adult patients undergoing cardiac surgery. The effect was seen only in patients having an active inotropic drug for comparison and not in the placebo subgroup. Therefore, the question remains whether milrinone increased mortality or if the control inotropic drugs were more protective.

"OBJECTIVE: With more than 220 million major surgical procedures performed annually, perioperative interventions leading to even minor mortality reductions would save thousands of lives per year. This international consensus conference aimed to identify all nonsurgical interventions that increase or reduce perioperative mortality as suggested by randomized evidence.. . DESIGN AND SETTING: A web-based international consensus conference.. . PARTICIPANTS: More than 1,000 physicians from 77 countries participated in this web-based consensus conference.. . INTERVENTIONS: Systematic literature searches (MEDLINE\/PubMed, June 8, 2011) were used to identify the papers with a statistically significant effect on mortality together with contacts with experts. Interventions were considered eligible for evaluation if they (1) were published in peer-reviewed journals, (2) dealt with a nonsurgical intervention (drug\/technique\/strategy) in adult patients undergoing surgery, and (3) provided a statistically significant mortality increase or reduction as suggested by a randomized trial or meta-analysis of randomized trials.. . MEASUREMENTS AND MAIN RESULTS: Fourteen interventions that might change perioperative mortality in adult surgery were identified. Interventions that might reduce mortality include chlorhexidine oral rinse, clonidine, insulin, intra-aortic balloon pump, leukodepletion, levosimendan, neuraxial anesthesia, noninvasive respiratory support, hemodynamic optimization, oxygen, selective decontamination of the digestive tract, and volatile anesthetics. In contrast, aprotinin and extended-release metoprolol might increase mortality.. . CONCLUSIONS: Future research and health care funding should be directed toward studying and evaluating these interventions.. . "

"OBJECTIVE: Because at present no pharmacologic prevention or treatment of acute kidney injury seems to be available, the authors updated a meta-analysis to investigate the effects of fenoldopam in reducing acute kidney injury in patients undergoing cardiac surgery, focusing on randomized placebo-controlled studies only.. . DESIGN: A meta-analysis of randomized, placebo-controlled trials.. . SETTING: Hospitals.. . PARTICIPANTS: A total of 440 patients from 6 studies were included in the analysis.. . INTERVENTIONS: None. The ability of fenoldopam to reduce acute kidney injury in the perioperative period when compared with placebo was investigated.. . MEASUREMENTS AND MAIN RESULTS: Google Scholar and PubMed were searched (updated January 1, 2012). Authors and external experts were contacted. Pooled estimates showed that fenoldopam consistently and significantly reduced the risk of acute kidney injury (odds ratio [OR] = 0.41; 95% confidence interval [CI], 0.23-0.74; p = 0.003), with a higher rate of hypotensive episodes and\/or use of vasopressors (30\/109 [27.5%] v 21\/112 [18.8%]; OR = 2.09; 95% CI, 0.98-4.47; p = 0.06) and no effect on renal replacement therapy, survival, and length of intensive care unit or hospital stay.. . CONCLUSIONS: This analysis suggests that fenoldopam reduces acute kidney injury in patients undergoing cardiac surgery. Because the number of the enrolled patients was small and there was no effect on renal replacement therapy or survival, a large, multicenter, and appropriately powered trial is needed to confirm these promising results.. . "

"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.. . "

Aims Transoesophageal echocardiography (TEE) may require patient sedation, eventually leading to respiratory depression, a risky condition in severe cardiac disease. Non-invasive ventilation (NIV) has been applied during diagnostic manoeuvres, but its use during TEE has not been reported. We describe NIV-aided continuous TEE monitoring under sedation in the supine position in three consecutive orthopnoeic patients with severe aortic valve stenosis: two of them underwent percutaneous aortic valve implantation, and one underwent aortic valvuloplasty. Methods and results The TEE probe was passed through a hole performed with a surgical cutter in an NIV face-mask. Pulsoximetry, heart rate, arterial blood pressure, respiratory rate, arterial blood gases, patients' comfort, and patient's sedation were monitored throughout the procedure. Percutaneous aortic valve implantation procedures lasted almost 2 h, while the valvuloplasty procedure lasted 70 min. Non-invasive ventilation and continuous TEE were performed throughout the procedures without technical problems or respiratory or haemodynamic complications, and all patients felt always comfortable. Conclusion Non-invasive ventilation through a modified face-mask allowed to perform continuous TEE examination and to avoid tracheal intubation and general anaesthesia in three high-risk patients undergoing beating heart treatment of aortic valve stenosis.

Objective: Controversial results exist on the effects of spinal analgesia in cardiac surgery. The authors conducted a review of randomized studies to show whether there are any advantages in clinically relevant outcomes using spinal analgesia in patients undergoing cardiac surgery. Design: Meta-analysis. Setting: Multiple hospitals. Participants: A total of 1,106 patients from 25 randomized trials. Interventions: None. Measurements and Main Result: Pub Med, BioMedCentral, CENTRAL, EMBASE, Cochrane Central Register of Controlled Trials, and conference proceedings were searched (updated January 2009) for randomized trials that compared general anesthesia with an anesthetic plan including spinal analgesia in cardiac surgery. Four independent reviewers performed data extraction, with divergences resolved by consensus. A total of 1,106 patients from 25 randomized studies were included in the analysis. Overall analysis showed that there were no differences in terms of mortality (2/562 [0.4%] in the spinal group v2/514 [0.4%] in the control arm [risk difference (RD) = 0.00 [-0.02, +0.02], p = 1.01, perioperative myocardial infarction (9/421 [2.1%] in the spinal group v 11/407 [2.7%] in the control arm [RD = 0.00, (0.03, +0.02), p = 0.77), and the length of hospital stay (WMD = -0.28 days [-0.68, -0.13], p = 0.18, with 419 included patients). Conclusions: This analysis indicated that spinal analgesia does not improve clinically relevant outcomes in patients undergoing cardiac surgery, discouraging further randomized controlled trials on this topic even if changes in techniques, devices, and drugs could modify the outlook of the comparison between spinal and standard anesthesia in this setting. (C) 2009 Elsevier Inc. All rights reserved.

Percutaneous aortic valve implantation is an emergent technique alternative to surgical aortic valve replacement in high risk patients with aortic stenosis. Percutaneous aortic valve implantation techniques are undergoing rapid development and currently represent a dynamic field of research. Perioperative optimal strategies keep on evolving too. At a review of the literature, only three previous papers on Pubmed focused specifically on anesthesiological challenges of percutaneous aortic valve implantation. In one of them our first 6 months experience was reported. In this new paper we describe the anesthesiological management of percutaneous aortic valve implantation at our Centre, reporting the results of our implantation program from November 2007 to February 2009.

Objective: To describe 6 months of experience in the anesthetic management of percutaneous aortic valve implantation. Design: An observational, cohort study. Setting: A university hospital. Participants: Eighteen high-risk patients with relative contraindications to surgical valve replacement (78 +/- 8.7 years, logistic EuroSCORE 26 +/- 19.1). Intervention: An Edwards/Sapien Aortic Bioprosthesis (Edwards Lifesciences LLC, Irvine, CA) was implanted in patients with severe symptomatic aortic stenosis who underwent percutaneous retrograde aortic valve implantation without cardiopulmonary bypass. The procedure was performed using general anesthesia (15 patients) or sedation (3 patients). Measurements and Main Results: The valve was successfully implanted in all patients. One patient had prolonged ventricular fibrillation that required advanced cardiopulmonary resuscitation, endotracheal intubation, and placement of an intra-aortic balloon pump. Six patients had vascular access site complications managed either percutaneously or surgically. Five patients were extubated in the catheterization laboratory. All patients were transferred to the intensive care unit for monitoring, and all but one were discharged to an intermediate care unit within 24 hours. Early postoperative complications included acute renal failure (1 patient), arrhythmias (1 atrial fibrillation and 1 transient heart block), and stroke (1 patient). One patient died 58 days after the procedure for noncardiac reasons. Conclusions: Transcatheter aortic valve implantation is possible in selected high-risk patients. Anesthesiologists must be aware of current technology in order to have an active role in patient selection, to develop monitoring and standards of care in the cardiac catheterization laboratory, and to plan postoperative management. (C) 2009 Elsevier Inc. All rights reserved.