Statin loading before coronary artery bypass grafting: a randomized trial.

AIMS: Evidence suggests that a high-dose statin loading before a percutaneous coronary revascularization improves outcomes in patients receiving long-term statins. This study aimed to analyse the effects of such an additional statin therapy before surgical revascularization. METHODS AND RESULTS: This investigator-initiated, randomized, double-blind, and placebo-controlled trial was conducted from November 2012 to April 2019 at 14 centres in Germany. Adult patients (n = 2635) with a long-term statin treatment (≥30 days) who were scheduled for isolated coronary artery bypass grafting (CABG) were randomly assigned to receive a statin-loading therapy or placebo at 12 and 2 h prior to surgery using a web-based system. The primary outcome of major adverse cardiac and cerebrovascular events (MACCE) was a composite consisting of all-cause mortality, myocardial infarction (MI), and a cerebrovascular event occuring within 30 days after surgery. Key secondary endpoints included a composite of cardiac death and MI, myocardial injury, and death within 12 months. Non-statistically relevant differences were found in the modified intention-to-treat analysis (2406 patients; 1203 per group) between the statin (13.9%) and placebo groups (14.9%) for the primary outcome [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.74-1.18; P = 0.562] or any of its individual components. Secondary endpoints including cardiac death and MI (12.1% vs. 13.5%; OR 0.88, 95% CI 0.69-1.12; P = 0.300), the area under the troponin T-release curve (median 0.398 vs. 0.394 ng/ml, P = 0.333), and death at 12 months (3.1% vs. 2.9%; P = 0.825) were comparable between treatment arms. CONCLUSION: Additional statin loading before CABG failed to reduce the rate of MACCE occuring within 30 days of surgery.

Improving the effectiveness of CPR during interventional procedures.

INTRODUCTION: The number of interventional procedures, such as transcatheter aortic valve replacements or thoracic endovascular aortic repairs, is on the rise. Intraprocedural cardiac arrest is a rare occurrence during high-risk procedures. Modern hybrid-operating tables may adversely affect chest compression quality due to their flexibility. To investigate this relationship, we analyzed the blood pressure generated during chest compressions at different degrees of table extension and assessed the effect of an additional stabilization bar to secure the table. METHODS: A CPR manikin was connected to online blood pressure monitoring on a hybrid operating table. Chest compressions were administered using a mechanical device (at 100 bpm and 80 bpm). Hemodynamic effects were evaluated at various degrees of table extension (0%, 50%, 100% table extension) and with the addition of a stabilization bar. RESULTS: A greater degree of table extension was associated with lower diastolic blood pressure. The addition of a stabilization bar alleviated this drop in diastolic blood pressure and enabled the generation of higher mean arterial pressures at 50% and 100% table extension during chest compressions. CONCLUSION: The flexibility of a hybrid operating table adversely impacts the hemodynamic effect of chest compressions. This effect may be mitigated by using a stabilization bar. These results may be relevant for providing further recommendations for CPR guidelines in hybrid OR settings.

Factor Xa Inhibitors for Patients after Mechanical Heart Valve Replacement?

Patients with a mechanical heart valve need a lifelong anticoagulation due to the increased risk of valve thrombosis and thrombo-embolism. Currently, vitamin K antagonists (VKA) are the only approved class of oral anticoagulants, but relevant interactions and side effects lead to a large number of patients not achieving the optimal therapeutic target international normalized ration (INR). Therefore, steady measurements of the INR are imperative to ensure potent anticoagulation within a distinctive range. Direct oral anticoagulants (DOACs) with newer agents could serve as a possible alternative to VKAs in this patient cohort. DOACs are approved for several indications, e.g., atrial fibrillation (AF). They only have a minor interaction potential, which is why monitoring is not needed. Thereby, DOACs improve the livability of patients in need of chronical anticoagulation compared with VKAs. In contrast to dual platelet inhibition using aspirin in combination with an ADP receptor antagonist and the direct thrombin inhibitor dabigatran, the oral factor Xa inhibitors apixaban and rivaroxaban show promising results according to current evidence. In small-scale studies, factor Xa inhibitors were able to prevent thrombosis and thrombo-embolic events in patients with mechanical heart valves. Finally, DOACs seem to represent a feasible treatment option in patients with mechanical heart valves, but further studies are needed to evaluate clinical safety. In addition to the ongoing PROACT Xa trial with apixaban in patients after aortic On-X valve implantation, studies in an all-comer collective with rivaroxaban could be promising.

Outcomes and Characteristics of Patients with Intraprocedural Cardiopulmonary Resuscitation during TAVR.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an established alternative to surgical aortic valve replacement (AVR) for higher risk patients. Periprocedural TAVR complications decreased with a growing expertise of implanters. Yet, TAVR can be accompanied by life-threatening adverse events such as intraprocedural cardiopulmonary resuscitation (CPR). This study retrospectively analyzed predictors and outcomes in a cohort of patients from a high-volume center undergoing periprocedural CPR during TAVR. METHODS: A total of 729 patients undergoing TAVR, including 59 with intraprocedural CPR, were analyzed with respect to peri- and postprocedural outcomes. RESULTS: Patients undergoing CPR showed a significantly lower left ventricular ejection fraction (LVEF) and lower baseline transvalvular mean and peak pressure gradients. The systolic blood pressure measured directly preoperatively was significantly lower in the CPR cohort. CPR patients were in a higher need for intraprocedural defibrillation, heart-lung circulatory support, and conversion to open heart surgery. Further, they showed a higher incidence of atrioventricular block grade III , valve malpositioning, and pericardial tamponade. The in-hospital mortality was significantly higher after intraprocedural CPR, accompanied by a higher incidence of disabling stroke, new pacemaker implantation, more red blood cell transfusion, and longer stay in intensive care unit. CONCLUSION: Impaired preoperative LVEF and instable hemodynamics before valve deployment are independent risk factors for CPR and are associated with compromised outcomes. Heart rhythm disturbances, malpositioning of the prosthesis, and pericardial tamponade are main causes of the high mortality of 17% reported in the CPR group. Nevertheless, mechanical circulatory support and conversion to open heart surgery reduce mortality rates of CPR patients.

Ten-Year Long-Term Analysis of Mechanical and Biological Aortic Valve Replacement.

BACKGROUND: For patients undergoing aortic valve replacement (AVR), structural valve deterioration (SVD) of a bioprosthesis (BP) is substantially accelerated in younger patients and valve-in-valve implantation is not always a considerable option. The risk-benefit assessment between SVD versus the risk of bleeding and thromboembolic events in patients with a mechanical prosthesis (MP) resulted in an age limit shift irrespective of inconsistent results reported in literature. METHOD: This retrospective single-center study compared 10-year long-term outcomes in patients undergoing isolated AVR with MP or BP. The risk-adjusted comparison of patients undergoing isolated AVR (n = 121) was performed after 1:1 propensity score matching (PSM) for age, sex, endocarditis, and chronic renal impairment (caliper of 0.2) leading to 29 pairs. Short- and long-term outcomes with respect to reoperation, major bleeding, stroke, all-cause and cardiovascular mortality, and overall survival at 10 years were analyzed. RESULTS: After PSM, groups were comparable with respect to preoperative characteristics, including patients with a mean age of 65 ± 3 years (MP) and 66 ± 4 years (BP) and an incidence rate of 6.9% for infective endocarditis in both cohorts. Short-term outcomes (transient neurologic disorder = 0.0 vs. 6.9%; stroke = 0.0%; in-hospital mortality = 3.4%) and in-hospital stays were comparable between MP and BP. CONCLUSION: After isolated AVR with MP and BP, 10-year long-term outcomes were comparable in the reported single-center cohort. MP can still be implanted safely without a disadvantage as regards long-term survival.

Preoperative Statin Therapy for Atrial Fibrillation and Renal Failure after Cardiac Surgery.

BACKGROUND: Performing cardiac surgery in patients with cardiovascular risk factors incorporates a steady risk for the development of postoperative complications. Perioperative statin intake was associated with an improvement of perioperative outcomes in these patients. However, the European Association for Cardio-Thoracic Surgery guidelines regarding the perioperative statin treatment were changed recently due to large studies reporting about relevant adverse effects related to statin therapy. METHODS: All relevant databases were searched including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and the metaRegister of Controlled Trials. Various registries were screened (National Research Register, the ClinicalTrials.gov, and gray literature) with search on online conference indices of relevant scientific meetings. No language restrictions were applied. RESULTS: We identified 10 randomized controlled studies summarizing 3,468 participants undergoing various kinds of cardiac surgical procedures. All included studies presented with marked differences regarding study design. Pooled analysis indicated that statin pretreatment was associated with a formally reduced incidence of postoperative atrial fibrillation (AF) (odds ratio [OR] 0.63, 95% confidence interval [CI] 0.39-1.00; p = 0.05) but with an increased incidence of renal failure (OR 1.20, 95% CI 1.01-1.44; p = 0.04) compared with control. Substantial heterogeneity was observed among studies reporting about AF. CONCLUSION: Current but sparse evidence reveals that statin pretreatment is associated with a higher rate of postoperative renal failure compared with control therapy but is ineffective to substantially reduce postoperative AF. Given the relevant heterogeneity among included studies, statin pretreatment cannot be generally recommended.

Higher incidence of perivalvular abscess determines perioperative clinical outcome in patients undergoing surgery for prosthetic valve endocarditis.

BACKGROUND: Cardiac surgery for prosthetic valve endocarditis (PVE) is associated with substantial mortality. We aimed to analyze 30-day and 1-year outcome in patients undergoing surgery for PVE and sought to identify preoperative risk factors for mortality with special regard to perivalvular infection. METHODS: We retrospectively analyzed data of 418 patients undergoing valve surgery for infective endocarditis between January 2009 and July 2018. After 1:1 propensity matching 158 patients (79 PVE/79 NVE) were analyzed with regard to postoperative 30-day and 1-year outcomes. Univariate and multivariable analyses were performed to identify potential risk factors for mortality. RESULTS: 315 patients (75.4%) underwent surgery for NVE and 103 (24.6%) for PVE. After propensity matching groups were comparable with regard to preoperative characteristics, clinical presentation and microbiological findings, except a higher incidence of perivalvular infection in patients with PVE (51.9%) compared to NVE (26.6%) (p = 0.001), longer cardiopulmonary bypass (166 [76-130] vs. 97 [71-125] min; p < 0.001) and crossclamp time (95 [71-125] vs. 68 [55-85] min; p < 0.001). Matched patients with PVE showed a 4-fold increased 30-day mortality (20.3%) in comparison with NVE patients (5.1%) (p = 0.004) and 2-fold increased 1-year mortality (PVE 29.1% vs. NVE 13.9%; p = 0.020). Multivariable analysis revealed perivalvular abscess, sepsis, preoperative AKI and PVE as independent risk factors for mortality. Patients with perivalvular abscess had a significantly higher 30-day mortality (17.7%) compared to patients without perivalvular abscess (8.0%) (p = 0.003) and a higher rate of perioperative complications (need for postoperative pacemaker implantation, postoperative cerebrovascular events, postoperative AKI). However, perivalvular abscess did not influence 1-year mortality (20.9% vs. 22.3%; p = 0.806), or long-term complications such as readmission rate or relapse of IE. CONCLUSIONS: Patients undergoing surgery for PVE had a significantly higher 30-day and 1-year mortality compared to NVE. After propensity-matching 30-day mortality was still 4-fold increased in PVE compared to NVE. Patients with perivalvular abscess showed a significantly higher 30-day mortality and perioperative complications, whereas perivalvular abscess seems to have no relevant impact on 1-year mortality, the rate of readmission or relapse of IE.

"Vascular Outlining": Augmented Imaging for Transfemoral Access-A Preclinical Investigation.

BACKGROUND: Advanced visualization software tools have been used in clinics to improve the safety and accuracy of transcatheter procedure. Imaging techniques have greatly evolved during the era of transcatheter aortic valve implantation (TAVI). In a retrospective analysis, we investigated the feasibility of augmented fluoroscopy for iliofemoral access using a novel "Vascular Outlining" roadmapping technology. METHODS: The Vascular Outlining prototype device (Philips Healthcare) application was used with iliofemoral angiography of 10 patients undergoing transfemoral TAVI. The software processes any conventional angiographic sequences, extracting the static outline of vessels and projecting the two-dimensional vessel margins as a roadmap on live fluoroscopy. Post-processed results were clinically assessed to determine whether the technical performance of the tool is sufficient. RESULTS: Augmented imaging was possible in all investigated angiography sequences. The analysis of software-generated images showed accurate projection of the two-dimensional outline of the iliofemoral vessels as an overlay on the live fluoroscopy image in most cases. Overlay inaccuracy was only observed in cases with low contrast or patient movement. CONCLUSION: In static and contrasted angiography sequences, "Vascular Outlining" showed accurate image overlay. We identified that the quality of the vascular outline is dependent on the opacification of the contrast injection and the stability of the patient on the table. With further development. this application might increase the accuracy of femoral puncture and reduce the incidence of vascular complications. Clinical trials are needed to confirm these hypotheses.

SAVR versus TAVI: What about the Hemodynamic Performance? An In Vivo and In Vitro Analysis.

BACKGROUND: Surgical aortic valve replacement (SAVR) is nowadays discussed whether it remains the gold standard of treatment. In the last decade, there has been a tremendous increase in transcatheter aortic valve implantation (TAVI) due to the growing expertise and excellent results of the catheter-based approach. We, therefore, retrospectively compared the rapid deployment valve (RDV), the Edwards Intuity valve (IEV), with the Edwards Sapien 3 (S3V) with regard to post-procedural hemodynamics. METHODS: A total of 246 patients treated with TAVI or SAVR between February 2009 and November 2015 were included. One-hundred twenty-five patients were analyzed in the SAVR group and compared with 121 patients undergoing TAVI. Transvalvular pressure gradients (PGs) and the incidence and extent of aortic regurgitation (AR) were compared post-procedurally by echocardiography for each valve size. In vitro hemodynamics were analyzed by placing both valves into an aortic silicone phantom connected to a pulsatile flow pump and measured using phase-contrast magnetic resonance imaging (4D flow MRI). RESULTS: Post-procedurally, mean transvalvular PGs for the 23 mm valves were 9 (7;11.5) versus 13 (9;18) (p < 0.001), whereas maximum PGs were 16.5 (14;22) versus 25.5 mm Hg (17.5;34) (p < 0.001) in IEV and S3V patients, respectively. The 21 mm IEV showed significantly lower transvalvular PGs compared with the 23 mm S3V: mean PGs: 11 (8;13) versus 13 (9;18) (p < 0.05); maximum PG: 19.5 (13;24) versus 25.5 (18;34) mm Hg (p < 0.05). Analysis revealed significantly lower post-procedural transvalvular PGs for larger valves sizes. With respect to AR, the incidence of AR was significantly lower in IEV group (p < 0.05). In vitro velocities and turbulent kinetic energy values showed similar results between both valves. CONCLUSION: Implanted RDVs presented a lower incidence of paravalvular regurgitation and were associated with significantly lower post-procedural transvalvular PGs, especially for small valve sizes. Our data might support the application of rapid deployment aortic valves in patients with small aortic annulus in the TAVI era.

Single center experience with patients on veno arterial ECMO due to postcardiotomy right ventricular failure.

OBJECTIVES: Right ventricular (RV) failure is associated with poor outcome and increased mortality in cardiac surgery. Aim of our study was to analyze the outcome of veno arterial extracorporeal membrane oxygenation (va ECMO) therapy in patients with isolated RV failure in postcardiotomy cardiogenic shock (PCS) and to evaluate risk factors associated with 30-day-mortality. METHODS: Between August 2006 until August 2016, 64 consecutive patients with va ECMO therapy due to fulminant RV failure in PCS were identified and included in this retrospective observation. Further, outcome data and a comparison of va ECMO survivors and nonsurvivors was conducted. RESULTS: The mean age of the patient cohort was 63 ± 14 years. Patients were treated with va ECMO for 79 ± 61 hours. Twenty-eight patients (44%) were successfully weaned off ECMO support. Overall 30-day-mortality was 88% (56/64). Hemoglobin concentration before ECMO implantation, maximum rise of muscle-brain type creatine kinase during ECMO therapy, as well as lactic acid concentration 24 hours after initiation of va ECMO therapy were predictive for 30-day mortality. CONCLUSION: ECMO therapy in RV failure due to PCS is shown to be associated with an excessive mortality. Regarding our data, va ECMO might only be an appropriate short-term mechanical assist device separating patients form cardiopulmonary bypass with an acceptable weaning rate. Particularly, in case of failed hemodynamic recovery of the right heart on va ECMO, direct RV bypass systems might function as a bailout option. Additionally, cardiac enzymes and lactic acid might provide valuable information in meeting therapy-related decisions.

Latest Generation of Balloon-Expandable Valve, the Edwards Sapien 3 Valve: Less Paravalvular Regurgitation but Higher Transvalvular Pressure Gradients.

BACKGROUND: The latest generation of balloon-expandable valve, the Edwards Sapien 3 valve (S3V), was designed to reduce paravalvular regurgitation (PVR). We retrospectively compared S3V with Edwards Sapien XT valve (SXTV) with regard to postprocedural transvalvular pressure gradients (PGs). METHODS: Analysis of 152 patients receiving SXTV and 125 patients receiving S3V between February 2009 and April 2015 was performed. Transvalvular PGs and the incidence and extent of aortic regurgitation (AR) were compared postprocedurally by echocardiography for each valve size. RESULTS: Postprocedurally, mean PGs for the 23 mm valves were 10.9 ± 5.3 versus 13.9 ± 5.1 (p = 0.017), whereas maximum PGs were 19.9 ± 8.3 versus 26.1 ± 10.4 mm Hg (p = 0.005) in SXTV and S3V patients, respectively. For the 26 mm valves, gradients were also significantly higher in S3V patients (mean PG: 11.6 ± 4.9 vs. 9.2 ± 4.2 [p = 0.004]; maximum PG: 23.0 ± 10.1 vs. 17.2 ± 7.4 mm Hg [p < 0.001]). Analysis revealed no significant differences in postprocedural transvalvular PGs for 29 mm valves (mean PG of 9.3 ± 3.9 and 11.2 ± 4.3 mm Hg [p = ns] and maximum PG of 17.5 ± 7.2 vs. 20.9 ± 6.8 mm Hg [p = ns]) between SXTV and S3V groups, respectively. With respect to PVR, the incidence of AR was significantly lower in S3V group (p = 0.001). CONCLUSION: S3V shows lower incidence of PVR; however, it is associated with significantly higher postprocedural transvalvular PGs for 23 and 26 mm valve sizes. These data might contribute to the scientific discussion, especially with respect to prosthesis selection in individual patients with small annular dimension.

Managing Traps and Pitfalls During Initial Steps of an ECMO Retrieval Program Using a Miniaturized Portable System: What Have We Learned From the First Two Years?

The aim of this study was to provide early and mid-term results of the newly established extracorporeal membrane oxygenation (ECMO) retrieval service in a tertiary cardiothoracic center using the miniaturized portable Cardiohelp System (Maquet, Rastatt, Germany). A particular attention was paid to organizational and logistic specifics as well as challenges and pitfalls associated with initial phase of the program. From January 2015 until January 2017 a heterogenic group of 28 consecutive patients underwent ECMO implantation in distant hospitals for acute cardiac, pulmonary or combined failure as a bridge-to-decision and were subsequently transported to our institution. Each cannulation was performed bedside on intensive care units (ICU) using the Seldinger's technique. Early outcomes and mid-term overall survival with up to two-year follow-up along with the impact of ongoing cardiopulmonary resuscitation (CPR) on outcome were presented. Also, changes in hemodynamics and tissue perfusion factors 24 h after ECMO implantation were evaluated. ECMO implantations were performed in 15 distant departments with the median distance of 23(10;40) (maximum 60) km. A total of 15 patients (54%) were cannulated under CPR with the median duration of 30(20;110) (maximum 180) min. After 24 h of support there were significant improvements in SvO2 (P = 0.021), mean arterial pressure (P = 0.027), FiO2 (P = 0.001), lactate (P = 0.001), and pH (P < 0.001). The mean ECMO support duration was 96 ± 100 (maximum 384) hours, whereas 11 patients (40%) were weaned off support and discharged from hospital. Overall cumulative survival in patients without the need for CPR was 61.5% at one week and 38.5% at 1 month, 6 month, and 1 year, whereas patients requiring CPR survived in 40% at one week, and 33.3% at 1 month, 6 month, and 1 year (Log-Rank (Mantel-Cox) P = 0.374, Breslow (Generalized Wilcoxon) P = 0.162). Our initial experience shows that launching new ECMO retrieval programs in centers with sufficient ICU capacities and local ECMO experience can be feasible and associated with acceptable "real world" results despite the initial learning curve. Rapid logistical organization and team flexibility are the key points to ensure comparable survival of patients requiring prolonged CPR.

Statin Therapy in Patients Undergoing Coronary Artery Bypass Grafting for Acute Coronary Syndrome.

BACKGROUND: This study evaluates whether preoperative statin therapy improves clinical outcomes in patients referred to coronary artery bypass grafting (CABG) for acute coronary syndrome (ACS). METHODS: A total of 1,151 patients undergoing CABG for ACS were prospectively entered into the North-Rhine-Westphalia surgical myocardial infarction registry and subdivided into two groups according to their preoperative statin status (statin naive vs. statin group). A logistic regression model was employed to analyze the impact of a statin therapy and dose for the endpoints in-hospital mortality and major adverse cardiac events (MACE). RESULTS: Demographics, pre- and intraoperative data of the statin-naive group (n = 208; 18%) and statin-treated group (n = 943, 82%) did not differ. In-hospital mortality (12.6 vs. 6.3%, p = 0.002) and MACE rates (22.1 vs. 9.7%, p < 0.001) were significantly higher in statin naive when compared with statin-treated patients with ACS, respectively. Mevalonic acid revealed that both low- and high-dose statin treatment was associated to a reduction in in-hospital mortality and MACE, without a dose-dependent statin effect. CONCLUSION: Statin therapy in patients with ACS undergoing CABG reduces in a dose-independent manner in-hospital mortality and MACE.

Buckberg versus Calafiore Cardioplegia in Patients with Acute Coronary Syndromes.

BACKGROUND: Choice of cardioplegic solution plays a pivotal role in special subgroups of patients referred for on-pump cardiac surgery. This retrospective analysis aimed to assess the impact of intermittent warm (Calafiore, Cala) versus intermittent cold blood cardioplegia (Buckberg, Buck) in patients referred to coronary artery bypass graft (CABG) surgery due to acute coronary syndromes (ACS). METHODS: From 2008 to 2015, all consecutive patients undergoing urgent on-pump CABG surgery due to ACS (n = 950) were retrospectively analyzed. Intraoperative cardiac arrest was achieved using Buck (n = 273) or Cala (n = 677). Patients were compared regarding clinical outcomes and perioperative myocardial injury (PMI). Propensity score matching was performed to control for differences in preoperative patient characteristics. RESULTS: Prevalences of left main stenosis >50%, COPD, and advanced New York Heart Association (NYHA) class were higher for intermittent warm blood cardioplegia (IWC)-patients while more Buck-patients had preoperative intra-aortic balloon pump (IABP) and redo procedures. Buck-patients needed more intraoperative defibrillations and showed longer cardiopulmonary bypass (CPB) and aortic clamping times. 30-day all-cause mortality (10.6 versus 9.3%), major adverse cardiac events (MACE) (52.7 versus 48.6%), and PMI (50.5 versus 55.7%; all p > 0.05) rates were comparable for Buck- and Cala-patients. Propensity score matching resulted in equal group sizes (n = 212 each) and balanced distribution of preoperative covariates. Although more Buck-patients still needed inotropic support >24 hours postoperatively (25.7 versus 14.7%; p = 0.005) compared with Cala-group, outcome variables of interest did not differ between treatment groups (30-day mortality: 7.5 versus 9.0%; MACE: 49.5 versus 40.6%; PMI: 48.1 versus 37.3%; all p > 0.05). CONCLUSION: Buckberg and Calafiore cardioplegia offer comparable myocardial protection and similar postoperative results in patients undergoing CABG surgery due to ACS.

Preoperative intra-aortic balloon pump use in high-risk patients prior to coronary artery bypass graft surgery decreases the risk for morbidity and mortality-A meta-analysis of 9,212 patients.

AIMS: Prophylactic intra-aortic balloon pump (IABP) support for high-risk patients before coronary artery bypass grafting (CABG) is controversial. This meta-analysis sought to determine the current role of preoperative IABP support. METHODS: We performed a meta-analysis of randomized (RCT) and observational trials (OT) that fulfilled the following criteria: (1) Group comparison of patients with prophylactic IABP implantation before CABG with a control group; (2) reporting at least one desired clinical endpoint, including all-cause mortality, myocardial infarction, cerebrovascular accident (CVA), and renal failure. Pooled treatment effects (odds ratio [OR] or weighted mean difference, and 95% confidence intervals [95%CI]) were assessed using a fixed or random effects model. RESULTS: A total of 9,212 patients from 23 studies (7 RCT, 16 OT) were identified after a literature search of major databases using a predefined keyword list. Absolute risk reduction for mortality in RCTs was 4.4% (OR 0.43; 95%CI 0.25-0.73; p = 0.0025). Prophylactic IABP use before CABG surgery also decreased the risk for myocardial infarction (OR 0.58; 95%CI 0.43-0.78; p = 0.004), CVA (OR 0.67; 95%CI 0.47-0.97; p = 0.042), and renal failure (OR 0.62; 95%CI 0.47-0.83; p = 0.0014). Length of intensive care unit stay (p < 0.0001) and length of hospital stay (p < 0.0001) were significantly reduced in patients with preoperative IABP use. CONCLUSION: Current evidence from RCT and OT suggests beneficial effects for the IABP in high-risk patients before CABG surgery.

Point-of-care thromboelastography/thromboelastometry-based coagulation management in cardiac surgery: a meta-analysis of 8332 patients.

OBJECTIVES: Severe bleeding related to cardiac surgery is associated with increased morbidity and mortality. Thromboelastography (TEG) and thromboelastometry (ROTEM) are point-of-care tests (POCT). Bedside ROTEM/TEG can rapidly detect changes in blood coagulation and therefore provide a goal-directed, individualized coagulation therapy. In this meta-analysis, we aimed to determine the current evidence for or against POCT-guided algorithm in patients with severe bleeding after cardiac surgery. METHODS: We performed a meta-analysis of randomized controlled trials and observational trials retrieved from a literature search in PubMed, EMBASE, and Cochrane Library. Only trials comparing transfusion strategy guided by TEG/ROTEM with a standard of care control group undergoing cardiac surgery were included. In addition, at least one clinical outcome had to be mentioned: mortality, surgical re-exploration rate, sternal wound infection, and acute kidney injury (AKI). Also, surrogate parameters such as transfusion requirements and amount of blood loss were analyzed. The pooled treatment effects (odds ratio [OR] and 95% confidence intervals [CI]) were assessed using a fixed or random-effects model. RESULTS: The literature search retrieved a total of 17 trials (nine randomized controlled trial and eight observational trials) involving 8332 cardiac surgery patients. POCT-guided transfusion management significantly decreased the odds for patients to receive allogeneic blood products (OR 0.63, 95% CI 0.56-0.71; P < 0.00001) and the re-exploration rate due to postoperative bleeding (OR 0.56, 95% CI 0.45-0.71; P < 0.00001). Furthermore, the incidence of postoperative AKI (OR 0.77, 95% CI 0.61-0.98; P = 0.0278) and thromboembolic events (OR 0.44, 95% CI 0.28-0.70; P = 0.0006) was significantly decreased in the TEG/ROTEM group. No statistical differences were found with regard to inhospital mortality, cerebrovascular accident, or length of intensive care unit and hospital stay. CONCLUSIONS: TEG/ROTEM-based coagulation management decreases the risk of allogeneic blood product exposure after cardiac surgery. Furthermore, it results in significantly lower re-exploration rate, decreased incidence of postoperative AKI, and thromboembolic events in cardiac surgery patients. Results of this meta-analysis indicate that POCT-guided transfusion therapy is superior to the current standard of care.

Statin Recapture Therapy before Coronary Artery Bypass Grafting Trial: Rationale and study design of a multicenter, randomized, double-blinded controlled clinical trial.

INTRODUCTION: Patients undergoing coronary artery bypass grafting (CABG) are still at significant risk for postoperative major adverse cardiac and cerebrovascular events (MACCEs). Recent clinical evidence shows that cardioprotection in patients receiving a chronic statin treatment can be "recaptured" by a high-dose statin therapy given shortly before an ischemia-reperfusion sequence. Evaluation of this novel therapeutic approach in the setting of CABG seems promising because myocardial ischemia-reperfusion injury plays a pivotal role in poor clinical outcomes that may be improved by a simple preoperative statin recapture treatment. METHODS: The investigator-initiated StaRT-CABG trial is a multicenter, randomized, double-blinded, 2-parallel group controlled clinical study in 2,630 patients. The trial aims to evaluate whether a high-dose statin recapture therapy given shortly before CABG reduces the incidence of MACCE at 30 days after surgery (primary composite outcome: all-cause mortality, nonfatal myocardial infarction, and cerebrovascular events). Consenting patients who are on chronic statin therapy before surgery will be randomized to receive either oral statin reloading therapy or matching placebo 12 and 2 hours before CABG. Key secondary end points include enzymatic myocardial injury; new-onset atrial fibrillation; length of stay in the intensive care unit and hospital; need for repeat coronary revascularization at 30 days; and, finally, all-cause mortality at 12 months after surgery. IMPLICATIONS: The StaRT-CABG trial is expected to provide highly relevant clinical data on the efficacy of this novel therapeutic approach to optimize the care for patients with coronary artery disease undergoing CABG.

Preoperative statin therapy for patients undergoing cardiac surgery.

BACKGROUND: Patients referred to cardiac surgery for cardiovascular disease are at significant risk for the development of major postoperative adverse events despite significant advances in surgical techniques and perioperative care. Statins (5-hydroxy-3-methylglutaryl-co-enzyme A (HMG-CoA) reductase inhibitors) have gained a pivotal role in the primary and secondary prevention of coronary artery disease and are thought to improve perioperative outcomes in patients undergoing cardiac surgery. This review is an updated version of a review that was first published in 2012. OBJECTIVES: To determine the effectiveness of preoperative statin therapy in patients undergoing cardiac surgery. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 11), MEDLINE (1950 to November 2013 Week 3), EMBASE (1980 to 3 December 2013 (Week 48)) and the metaRegister of Controlled Trials. Additionally, we searched ongoing trials through the National Research Register, the ClinicalTrials.gov registry and grey literature. We screened online conference indices from relevant scientific meetings (2006 to 2014) to look for eligible trials. We applied no language restrictions. SELECTION CRITERIA: All randomised controlled trials comparing any statin treatment before cardiac surgery, for any given duration and dose, versus no preoperative statin therapy (standard of care) or placebo. DATA COLLECTION AND ANALYSIS: Two review authors evaluated trial quality and extracted data from titles and abstracts identified by electronic database searches according to predefined criteria. Accordingly, we retrieved full-text articles of potentially relevant studies that met the inclusion criteria to assess definitive eligibility for inclusion. We reported effect measures as odds ratios (ORs) or weighted mean differences (WMDs) with 95% confidence intervals (95% CIs). MAIN RESULTS: We identified 17 randomised controlled studies including a total of 2138 participants undergoing on-pump or off-pump cardiac surgical procedures, and added to this review six studies with 1154 additional participants. Pooled analysis showed that statin treatment before surgery reduced the incidence of postoperative atrial fibrillation (AF) (OR 0.54, 95% CI 0.43 to 0.67; P value < 0.01; 12 studies, 1765 participants) but failed to influence short-term mortality (OR 1.80, 95% CI 0.38 to 8.54; P value = 0.46; two studies, 300 participants) or postoperative stroke (OR 0.70, 95% CI 0.14 to 3.63; P value = 0.67; two studies, 264 participants). In addition, statin therapy was associated with a shorter stay for patients on the intensive care unit (ICU) (WMD -3.19 hours, 95% CI -5.41 to -0.98; nine studies, 721 participants) and in the hospital (WMD -0.48 days, 95% CI -0.78 to -0.19; 11 studies, 1137 participants) when significant heterogeneity was observed. Results showed no reduction in myocardial infarction (OR 0.48, 95% CI 0.21 to 1.13; seven studies, 901 participants) or renal failure (OR 0.57, 95% CI 0.30 to 1.10; five studies, 467 participants) and were not affected by subgroup analysis. Trials investigating this safety endpoint reported no major or minor perioperative side effects of statins. AUTHORS' CONCLUSIONS: Preoperative statin therapy reduces the odds of postoperative atrial fibrillation (AF) and shortens the patient's stay on the ICU and in the hospital. Statin pretreatment had no influence on perioperative mortality, stroke, myocardial infarction or renal failure, but only two of all included studies assessed mortality. As analysed studies included mainly individuals undergoing myocardial revascularisation, results cannot be extrapolated to patients undergoing other cardiac procedures such as heart valve or aortic surgery.

Transcaval Transcatheter Aortic Valve Replacement for Pure Aortic Regurgitation Using a Dedicated Self-Expanding Device.

Novel dedicated devices allow transcatheter treatment of pure aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System was introduced as the first dedicated and on-label AR transcatheter aortic valve replacement system, implementing a locator-based and calcium-independent anchoring mechanism. Here, we present the first-in-human transcatheter aortic valve replacement for pure AR via a transcaval access in a patient with prohibitive alternative arterial accesses.

Intraoperative stress in cardiac surgery: attendings versus residents.

BACKGROUND: Performing cardiac surgery is associated with stress for surgeons. We investigated stress levels of experienced surgeons and trainees during coronary artery bypass graft teaching procedures. METHODS: We assessed heart rate (HR) and sympathovagal balance (SVB) of experienced surgeons (attendings; n = 7) and residents enrolled in a training program (residents; n = 3) using a one-lead electrocardiogram during a total of 109 elective isolated coronary artery bypass graft procedures. We measured HR and SVB for baseline values at rest and at prespecified phases during the procedure in the role as primary surgeons (n = 10) and assistants (n = 9). RESULTS: All participants were healthy men with a mean age of 41.4 ± 4.3 y. For patients operated on during this study, demographic and intraoperative data were homogeneous. Compared with rest, mean HR and SVB for the whole procedure were higher for surgeons and assistants, with significant differences for HR values (surgeons, 83.7 ± 8.8 beats/min [bpm]; assistants, 85.4 ± 12.7 bpm, P < 0.05 versus 62.3 ± 5.1 bpm). Courses of HR and SVB were comparable for attending and resident groups but values were higher throughout for attendings compared with residents in their role as surgeons during the total procedure, and as assistants during cardiopulmonary bypass. Mean HR and SVB values of attendings assisting the procedure were higher compared with those of residents performing the operation. CONCLUSIONS: Surgical experience is not associated with reduced stress levels. Supervising a teaching case in cardiac surgery can be linked with more stress compared with the resident performing the procedure.