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OBJECTIVES: There is extensive evidence to support the use of FIBTEM to identify hypofibrinogenemia during cardiac surgery, but less to support the use of EXTEM and INTEM clotting times (CTs) to identify other plasmatic coagulation factor deficiencies. The aim of the current study was to assess the diagnostic accuracy of EXTEM, INTEM, and HEPTEM CTs, using laboratory international normalized ratio (INR) and activated partial thromboplastin time (aPTT) as reference standards. DESIGN: This was a retrospective diagnostic accuracy study. SETTING: The work took place at a tertiary referral hospital. PARTICIPANTS: A total of 176 cardiac surgical patients were enrolled. INTERVENTIONS: INR, aPTT, ROTEM EXTEM, INTEM, and HEPTEM were measured post-heparin reversal after cardiopulmonary bypass. MEASUREMENTS AND MAIN RESULTS: Sensitivity, specificity, and positive (PPVs) and negative predictive values (NPVs) for EXTEM CT >80 seconds and HEPTEM CT >280 seconds to detect INR ≥2.0, and INTEM CT >205 seconds to detect aPTT ≥38.5 seconds were calculated for all patients and the subset with normal FIBTEM A5 (>6 mm). The prevalence of INR ≥2.0 was 13%. EXTEM CT >80 seconds had a sensitivity of 1.00, specificity of 0.25, PPV of 0.17, and NPV of 1.00. HEPTEM CT >280 seconds had a sensitivity of 0.91, specificity of 0.38, PPV of 0.18, and NPV of 0.97. INTEM CT >205 seconds had a sensitivity of 0.97, specificity of 0.11, PPV of 0.57, and NPV of 0.75 for aPTT ≥38.5 seconds. These values were similar for the subset of patients with normal FIBTEM A5. CONCLUSIONS: EXTEM CT >80 seconds and HEPTEM CT >280 seconds have high sensitivities and NPVs for INR >2.0, which would effectively "rule out" INR >2.0 as a cause for excessive bleeding. However, the low specificities and PPVs indicate they would be less effective in ruling it in. INTEM CT >205 seconds had low PPV and NPV in identifying aPTT >38.5 seconds.

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The ROTEM®delta (TEM Innovations GmbH, Munich, Germany) has been used extensively worldwide for the assessment of coagulation in cardiac surgical patients. Recently, a new cartridge-based ROTEM device (ROTEM®sigma, TEM Innovations GmbH, Munich, Germany) has become available. In this paper we report an audit of the diagnostic accuracy of the ROTEM sigma for the identification of hypofibrinogenaemia in cardiac surgical patients. We hypothesised that the diagnostic accuracy of the ROTEMsigma for the identification of hypofibrinogenaemia would be in a similar range to that previously reported for the ROTEMdelta. Simultaneous blood samples for Clauss laboratory fibrinogen and ROTEMsigma FIBTEM measurements were obtained immediately after heparin reversal post-cardiopulmonary bypass in 200 adult cardiac surgical patients. The sensitivity, specificity, and positive and negative predictive values for FIBTEM A5 and A10 for the identification of hypofibrinogenaemia (Clauss fibrinogen <1.5 g/l) were calculated. The prevalence of hypofibrinogenaemia across the 200 patients was 8%. The mean sensitivity and specificity of FIBTEM A10 ≤8 mm for the identification of hypofibrinogenaemia were 0.75 and 0.90 respectively, which are in a similar range to that reported in several previous studies using the ROTEMdelta. For FIBTEM A5 ≤6 mm the values were 0.63 and 0.98 respectively. The predictive values were also in a similar range to those previously reported for the ROTEMdelta, with low false negative rates (2% for A10 ≤8 mm; 3% for A5 ≤6 mm). These findings support the use of the ROTEMsigma as an alternative to the ROTEMdelta for the identification of hypofibrinogenaemia post-cardiopulmonary bypass in cardiac surgical patients. However, further studies are required in other settings.

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BACKGROUND: There is some interest in long-term survival after various cardiac surgical strategies, including off-pump versus on-pump coronary artery surgery (CAG), mitral valve (MV) repair versus replacement, and aortic valve (AV) bioprosthetic versus mechanical replacement. METHODS: We studied patients older than 49 years of age, recording risk factors and surgical details at the time of surgery. We classified procedures as: MV surgery with or without concurrent grafts or valves; AV surgery with or without concurrent CAG; or isolated CAG. Follow-up was through the state death register and state-wide hospital attendance records. Risk-adjusted survival was estimated using Cox proportional hazards. Observed survival was compared to the expected age- and sex- matched population survival. RESULTS: During a median follow-up of 14.8 years 5,807 of 11,718 patients died. The difference between observed and expected survival varied between 3.4 years for AV surgery and 9.6 years for females undergoing MV surgery. The risk-adjusted mortality hazard rate after off-pump CAG was 0.93 (95% CI 0.8-1.0, p=0.84), MV repair 0.67 (95% CI 0.6-0.8, p<0.0001), MV bioprosthesis 0.82 (95% CI 0.81 (0.6-1.0, p=0.11) and bioprosthetic AV replacement 1.02 (95% CI 0.9-1.2, p=0.82). CONCLUSIONS: Compared to the general population, cardiac surgical patients have a shorter than expected life expectancy. We observed a survival benefit of mitral valve repair over replacement. We did not observe significant survival differences between off-pump and on-pump CAG, nor between bioprosthetic and mechanical replacement.

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OBJECTIVE: Our unit began a minimally invasive mitral surgery (MIMS) program utilising antegrade Custodiol solution as the sole cardioplegia. The aim of this paper is to report our results of this program. PATIENTS/METHODS: Early clinical outcomes were identified and assessed for the first consecutive 100 MIMS patients with comparisons made to a historical group operated via a sternotomy (n=113). The efficacy of myocardial protection was assessed using surrogate outcomes of myocardial protection with serial sodium concentrations also analysed. RESULTS: Six hours postoperatively 12 patients required inotropic support. Peak troponin-I in the first 24 hours was 5.1 (0.8-40 µg/L [median(range)]. Sodium levels decreased following administration of Custodiol but by six hours postoperatively the sodium had returned to greater than 130 mmol/L in all but five patients. Blood transfusion was smaller in the MIMS versus historical group (RBC 17% vs. 65%). MIMS patients had a shorter duration of ventilation, hospital stay and one-year mortality rate (0%). CONCLUSIONS: In this series of patients undergoing MIMS, single dose antegrade Custodiol offers satisfactory and safe myocardial protection. Early clinical outcomes were also satisfactory. Whilst our findings are observational, they nevertheless support the use of this less invasive approach to mitral surgery using single dose Custodiol for myocardial protection.

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INTRODUCTION: Custodiol cardioplegia is attractive for minimally invasive cardiac surgery, as a single dose provides a long period of myocardial protection. Despite widespread use in Europe, there is little data confirming its efficacy compared with conventional (blood or crystalloid) cardioplegia. There is similar enthusiasm for its use in organ preservation for transplant, but also a lack of data. This systematic review aimed to assess the evidence for the efficacy of Custodiol in myocardial protection and as a preservation solution in heart transplant. METHODS: Electronic searches were performed of six databases from inception to October 2013. Reviewers independently identified studies that compared Custodiol with conventional cardioplegia (blood or extracellular crystalloid) in adult patients for meta-analysis; large case series that reported results using Custodiol were analyzed. Next, we identified studies that compared Custodiol with other organ preservation solutions for organ preservation in heart transplant. RESULTS: Fourteen studies compared Custodiol with conventional cardioplegia for myocardial protection in adult cardiac surgery. No difference was identified in mortality; there was a trend for increased incidence of ventricular fibrillation in the Custodiol group that did not reach statistical significance. No difference was identified in studies that compared Custodiol with other solutions for heart transplant. CONCLUSIONS: Despite widespread clinical use, the evidence supporting the superiority of Custodiol over other solutions for myocardial protection or organ preservation is limited. Large randomised trials are required.