Gender-Dependent Clinical Outcome and Other Predictors of In-Hospital Mortality Following Out-Of-Center Extracorporeal Membrane Oxygenation and Extracorporeal Life Support: A Single Center Experience.

BACKGROUND: Out-of-center extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) implantation for the treatment of acute cardiorespiratory failure with subsequent transport to a tertiary care center has been introduced successfully into the medical practice. However, due to the very specific and resource intensive nature of this therapeutic concept, it seems important to generate algorithms for adequate patient selection. The aim of our study was to analyze the impact of patients' gender on early clinical outcome in this specific therapeutic scenario. METHODS: Ninety-seven consecutive patients treated by out-of-center ECMO/ECLS implantation and subsequent transport and treatment in our tertiary care cardiovascular center within the Hallesche Extracorporeal Life Support Program (HELP) retrospectively were analyzed, regarding the impact of patients' gender on early clinical outcome. RESULTS: Mechanical circulatory support successfully was weaned in two-thirds of the male patients. This result was achieved in only one-third of the female patients (59.4% in male vs. 33.3% in female, P = .0267). Overall survival significantly was higher in the male group (62.5% in male versus 30.3% in female, P = .0052). In uni- and multivariate logistic regression analysis, female gender was an independent predictor of in-hospital mortality (uni: OR:3.833, CI:1.597-9.745, P = .0034; multi: OR:3.477, CI:1.146-11.494, P = .0322). Worse outcome also was associated with following independent predictors, age, SOFA score, lactate and ventilation time pre-ECMO/ECLS implantation. CONCLUSION: The current study demonstrates a worse early survival for women, following emergent out-of- center ECMO/ECLS implantation and subsequent transport and treatment in our tertiary care cardiovascular center. Gender should be included in patient selection algorithms while basic research approaches are needed to better understand the mechanisms underlying these gender- specific outcome disparities.

Transaortic Transcatheter Aortic Valve Implantation: Learning Curve, Perioperative, and Midterm Follow-Up Results of a Single Center.

BACKGROUND: We present our initial institutional experience with transaortic (TAo) transcatheter aortic valve implantation (TAVI) using a self-expanding aortic bioprosthesis. METHODS: A total of 106 patients underwent TAo TAVI with Medtronic CoreValve through a small partial upper sternotomy. We focus our analysis on the overall perioperative results, procedural learning curve (first 30 patients), and midterm follow-up outcomes. RESULTS: VARC-2 device success was achieved in 95 patients (89%), and there were no intraoperative deaths. Nine patients (8.4%) required a second valve and conversion to standard surgery was required in 2 patients (1.8%). The final aortic insufficiency was grade 0 in 65 patients (62%) and grade 1 in 39 (37%). Although patients treated in the TAo TAVI learning phase required a significantly longer radiation time and contrast agent use, device success (93.4% versus 88.2%, P = .7) and prostheses hemodynamics were similar. All-cause mortality at 30 days was 12% (13/106). At a median follow-up of 392 days (IQR: 216-494 days) estimated overall 1-year survival was 72%. No significant differences were reported in terms of 30-day and 1-year observed mortality, and estimated 1-year survival in the learning and later phase of TAo TAVI. CONCLUSION: TAo TAVI can be performed safely even in the very early phase of the learning curve. Although satisfactory results can be achieved from the beginning, a significant reduction in contrast agent use and radiological exposure are expected as the technique is mastered. Good hemodynamics have been documented and should be further improved with modifications achieved in the TAVI self-expandable valves technology.

Rotational Thromboelastometry for Assessing Bleeding Complications and Factor XIII Deficiency in Cardiac Surgery Patients.

We aimed to detect alterations and deficits in hemostasis during cardiac surgery with cardiopulmonary bypass (CPB) using point-of-care-supported coagulation analysis (rotational thromboelastometry, impedance aggregometry), in addition to single factor assays for the measurement of fibrinogen (FI) and factor XIII (FXIII) levels. Forty-one patients scheduled for elective cardiac surgery with CPB were enrolled in this observational study. Perioperative measurement (pre-, postheparin, 30-minutes before the end of bypass, 1-hourpostoperatively) of standard laboratory variables, additional rotational thromboelastometry (ROTEM; International GmbH, Munich, Germany), Multiplate analysis (Roche, Switzerland), and an assay of FXIII activity were performed as well as the collection of epidemiological data and blood loss. The FI and FXIII levels as well as the measured ROTEM and Multiplate parameters correlated weakly with the blood loss. Clotting time and maximum clot firmness (MCF) of the intrinsically activated ROTEM showed a good correlation (rCT-INTEM = 0.378; P < .05, rMCF-INTEM = 0.305; P < .05) with postoperative drainage loss, suggesting a dependence of blood loss on the initial intrinsic activity. Additionally, perioperative FI or FIBTEM levels and the FXIII levels correlated with each other. Intrinsically activated ROTEM showed a good correlation with postoperative drainage loss, thus suggesting a dependence of blood loss on the initial intrinsic activity and therefore facilitating clinicians to assess postoperative bleeding complications. Based on the FI level or the MCFFIBTEM measured by ROTEM, it may also be possible to assess the FXIII concentration. Especially in chronically ill and massive bleeding cardiac surgery patients with significantly decreased FXIII levels, the knowledge of FXIII deficiency may help clinicians to treat coagulation disorders more adequately.

Cardiac surgery score (CASUS) improves outcome prediction in patients treated with extracorporal life support (ECLS).

INTRODUCTION: The often-unexpected necessity of extracorporeal life support (ECLS) implies that information on patients and end-organ functions at time of implantation is scarce. However, there is a need for early prognostic indicators and a score predicting the outcome. Therefore, we evaluated established laboratory parameters and widely used intensive care scores - cardiac surgery score (CASUS) and sequential organ failure assessment (SOFA) after ECLS implantation. METHODS: In this retrospective analysis, 90 consecutive adult patients with veno-arterial ECLS were included. Baseline demographic data, laboratory markers, CASUS and SOFA were acquired 12 h after ECLS implantation. RESULTS: A total of 61 patients (67.8%) could be weaned from ECLS and 48 patients (53.3%) were discharged from hospital. Four patients were switched to a left ventricular assist device. The outcome did not depend on indication for ECLS. Furthermore, multivariable regression analysis identified lactate (OR=1.08; 95%CI: 1.01-1.26; p=0.03) and urine output (OR=0.99; 95%CI: 0.986-0.998; p=0.01) as independent predictors of in-hospital mortality. Evaluating intensive care scores, CASUS (AUROC=0.68; 95%CI: 0.57-0.77; p=0.002) had a higher prognostic relevance in comparison with SOFA (AUROC=0.58; 95%CI: 0.47-0.69; p=0.187). CONCLUSIONS: Our data indicate that lactate and urine output are early independent predictors for in-hospital mortality of ECLS patients. The CASUS proved to be a satisfactory evaluation tool with good prognostic abilities in these special patients.

A new technique to implant a transcatheter inflatable, fully repositionable prosthesis in aortic stenosis with severe asymmetric calcification.

OBJECTIVES: In contrast to stented transcatheter aortic valves, the Direct Flow Medical (DFM) valve is a stentless bovine aortic bioprosthesis mounted in a non-metallic inflatable frame. Hence, severe asymmetric annular calcification may result in residually elevated transaortic pressure gradients after DFM implantation. We present a novel intraprocedural dilatation (IDIL) technique for successful implantation of the DFM valve in the presence of complex annular calcification. METHODS: Between January 2014 and May 2015, 55 patients underwent DFM valve-based transcatheter aortic valve implantation at our institution. Of these, 5 patients required an IDIL technique due to a residual intraoperative transaortic pressure mean gradient above 15 mmHg. The mean patient age was 73 ± 8.2 years; the mean logistic EuroSCORE was 24.5 ± 8.2% and the mean Society of Thoracic Surgeons score was 6.3 ± 4.3%. RESULTS: The IDIL technique immediately attenuated transvalvular mean pressure gradients from 20 ± 2 mmHg to 6 ± 1 mmHg. The results remained stable during the 30-day observation period at 10 ± 3 mmHg. Minimal paravalvular aortic regurgitation (trace) was detected in 2 patients. No in-hospital deaths were observed. CONCLUSIONS: The IDIL technique facilitates safe DFM valve implantation in patients with complex asymmetric annular calcification without adverse side effects on valve structure or performance in short-term follow-up.

Predictors for quality of life of patients with a portable out-of-centre-implanted extracorporeal membrane oxygenation device.

Objectives: Despite progress in the treatment of cardiopulmonary organ failure, the mortality rate for patients with acute respiratory distress syndrome (ARDS) and cardiogenic shock remains high. Extracorporeal membrane oxygenation (ECMO) is a promising treatment option, but long-term outcomes and health-related quality of life (HRQOL) are unknown. Methods: Detailed information related to pre- and post-device data and outcomes from a consecutive sample of 71 patients treated with ECMO was analysed. Long-term survivors were given a detailed follow-up examination after a median time of 31 months that included multiple scoring systems for HRQOL assessment. Results: Seventy-one patients received a portable out-of-centre-implanted ECMO system. The survival rate at hospital discharge was 48%. Median HRQOL scores were 80% on the Karnofsky index (normal ≥80%), 80% on the Euroqol-5D (normal ≥75%) and 73.1% on the quality-of-life index (normal ≥70%). Mental scores were 96.7% on the Mini-Mental State Examination (normal ≥90.0%), 77.8% on the DemTect (normal ≥72.0%), 87.0% on the test for early detection of dementia with depression demarcation (TFDD; normal ≥74.0%) and confirmed good mental state and HRQOL for patients at follow-up. Univariate analysis for in-hospital mortality indicated that ventilation time before device implantation, higher Acute Physiology and Chronic Health Evaluation (APACHE) II score, higher lactate level at the time of ECMO implantation and female gender were associated with adverse outcomes. Conclusions: In our cohort of patients, survivors of out-of-hospital ECMO implantation demonstrated good mental and quality-of-life conditions with well-recovered cardiopulmonary function during long-term follow-up. The indicators for adverse outcomes, pre-implantation lactate levels, pre-ventilation time and APACHE II score, should be considered before implantation of an ECMO device. Clinical trial: This study is registered at DRKS (Deutsches Register Klinischer Studien) under the code DRKS00009735 and was submitted to the WHO.

Direct aortic access for transcatheter aortic valve replacement with a fully repositionable and retrievable nonmetallic valve system.

OBJECTIVE: The standard procedure of transcatheter aortic valve implantation involves transfemoral access. Nevertheless, the use of this access route is limited by the vessel diameter, calcification, and tortuosity, making a subgroup of patients ineligible for peripheral access. We report the first use of direct aortic transcatheter aortic valve implantation with the Direct Flow Medical valve (Direct Flow Medical, Inc, Santa Rosa, Calif) in 15 patients at the Halle-Wittenberg University. METHODS: Between January 2014 and May 2015, 55 patients with severe aortic valve disease underwent transcatheter aortic valve implantation with the Direct Flow Medical valve at the Halle-Wittenberg University. Subgroups of 15 patients were treated using direct aortic access because of small vessel diameter, excessive calcification, or extreme tortuosity of the iliofemoral vessels. RESULTS: The mean patient age was 79.1 ± 6.72 years, and 10 patients (66%) were male. The mean logistic European System for Cardiac Operative Risk Evaluation was 23.4% ± 16.9%, and the mean Society of Thoracic Surgeons score was 7.8% ± 6.8%. Access related to redo-sternotomy during transcatheter aortic valve implantation was required in 4 patients (27%). Valve retrieval was performed in 2 patients (13%). There was no conversion to surgical aortic valve replacement and no incidence of major stroke. The postimplant mean gradient was 9.3 ± 2.5 mm Hg. No patient had moderate or severe paravalvular leakage. All patients survived the first 30 days. CONCLUSIONS: Direct aortic access seems to be a feasible and safe endovascular alternative for implantation of the Direct Flow Medical valve. This access provides direct and accurate control of the entire implantation procedure.

Continuous intraoperative monitoring of vagus and recurrent laryngeal nerve function in patients with advanced atrioventricular block.

PURPOSE: Intraoperative neuromonitoring of recurrent laryngeal nerve function after stimulation of the vagus nerve has been embraced as a risk minimization tool in thyroid surgery to prevent recurrent laryngeal nerve injury. Because this technology is increasingly used in an elderly and sicker population, the present study was conducted to determine the safety of this method in patients with second- or third-degree atrioventricular block. METHODS: This study aimed at evaluating the feasibility and safety of continuous intraoperative neuromonitoring (CIONM) in patients with second- or third-degree atrioventricular block. RESULTS: A total of six patients (12 nerves at risk), accounting for 0.3 % of all 1800 patients (3049 nerves at risk) who underwent thyroid surgery during the study period, were found to have second- or third-degree atrioventricular block. All these patients maintained normal systolic and diastolic blood pressures; heart rate; and peripheral arterial oxygen saturation before, during, and after CIONM. No clinically relevant changes in heart rate or blood pressure, cardiac arrhythmia, or other hemodynamically important events were noted despite careful monitoring of these patients. There was no interference between the biphasic waveform of the vocal muscle electromyogram and the spikes generated by the implanted cardiac pacemakers. Outcomes were uneventful with normal vocal fold and parathyroid gland function. CONCLUSIONS: Within the limitations of this series and considering experimental, animal, and human data, continuous IONM of the vagus nerve at ≤2 Hz seems to be reasonably safe. Additional research is warranted to confirm these results in larger groups of patients with advanced atrioventricular block.

Abdominal surgery in pregnancy--an interdisciplinary challenge.

BACKGROUND: Abdominal operations are performed during ca. 2% of all pregnancies. They represent an unusual situation not only for the patient, but also for the involved surgeons and anesthesiologists. Appendectomy, followed by cholecystectomy are the two most common types of operation performed during pregnancy. Special questions arise with regard to the peri- and intraoperative management and the optimal surgical approach. METHOD: This review is based on pertinent articles retrieved by a selective search in the PubMed database. RESULTS: The question of laparoscopy versus laparotomy during pregnancy has been addressed to date only in case series and a few meta-analyses. Two meta-analyses have shown a significantly higher rate of miscarriage after laparoscopic, compared to open, appendectomy (relative risk [RR] 1.91, 95% confidence interval [CI] 1.31-2.77). The risk of preterm birth is also somewhat higher after laparoscopic appendectomy according to one meta-analysis on this subject (RR 1.44, 95% CI 0.78-1.76), but significantly lower according to another meta-analysis (2.1% vs. 8.1%, p<0.0001). For cholecystectomy, laparoscopy was associated with a lower miscarriage rate than laparotomy (1 in 89 cases, versus 2 in 69 cases), but with a somewhat higher preterm birth rate (6 in 89 cases, versus 2 in 69 cases). Delay or non-performance of surgery in a patient with appendicitis or cholecystitis can lead to additional hospitalizations, a higher miscarriage rate, premature rupture of the membranes, and preterm birth. CONCLUSION: Laparoscopy in experienced hands is safe even during pregnancy, with the recognized advantages of minimally invasive surgery, yet it carries a higher miscarriage rate than laparotomy, with a comparable preterm birth rate. Before surgery, patients should be thoroughly informed about the operation they are about to undergo and the advantages and disadvantages of the available surgical approaches.

Antithrombin III, but not C1 esterase inhibitor reduces inflammatory response in lipopolysaccharide-stimulated human monocytes in an ex-vivo whole blood setting.

In order to examine the immunomodulatory effects of antithrombin III (AT-III) and C1 esterase inhibitor (C1-INH) in human monocytes, we investigated the intracellular expression of interleukin (IL)-6, IL-8, and tumor necrosis factor (TNF)-α in an ex-vivo laboratory study in a whole blood setting. Heparinized whole blood samples from 23 healthy male and female volunteers (mean age: 27±7years) were pre-incubated with clinically relevant concentrations of AT-III (n=11) and C1-INH (n=12), then stimulated with 0.2 ng/mL lipopolysaccharide (LPS) for 3h. After phenotyping CD14⁺ monocytes, intracellular expression of IL-6, IL-8, and TNF-α was assessed using flow cytometry. In addition, 12 whole blood samples (AT-III and C1-INH, n=6 each) were examined using hirudin for anticoagulation; all samples were processed in the same way. To exclude cytotoxicity effects, 7-amino-actinomycin D and Nonidet P40 staining were used to investigate probes. This study is the first to demonstrate the influence of C1-INH and AT-III on the monocytic inflammatory response in a whole blood setting, which mimics the optimal physiological setting. Cells treated with AT-III exhibited significant downregulation of the proportion of gated CD14⁺ monocytes for IL-6 and IL-8, in a dose-dependent manner; downregulation for TNF-α did not reach statistical significance. There were no significant effects on mean fluorescence intensity (MFI). In contrast, C1-INH did not significantly reduce the proportion of gated CD14⁺ monocytes or the MFI regarding IL-6, TNF-α, and IL-8. When using hirudin for anticoagulation, no difference in the anti-inflammatory properties of AT-III and C1-INH in monocytes occurs. Taken together, in contrast to TNF-α, IL-6 and IL-8 were significantly downregulated in monocytes in an ex-vivo setting of human whole blood when treated with AT-III. This finding implicates monocytes as an important point of action regarding the anti-inflammatory properties of AT-III in sepsis. C1-INH was unable to attenuate the monocytic response, which supports the hypothesis that other cellular components in whole blood (e.g., neutrophils) might be responsible for the known effects of C1-INH in inflammation.

Anesthetic management in patients undergoing hyperthermic chemotherapy.

PURPOSE OF REVIEW: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has become an important therapeutic option for selected patients with peritoneal surface malignancies. This aggressive multimodality treatment is complex, not only regarding surgical technique, but also regarding anesthesia. The present review represents our experience in anesthetic care. RECENT FINDINGS: Improved prognosis compared with systemic chemotherapy alone has recently been demonstrated for cytoreductive surgery when combined with intraoperative intracavitary hyperthermic chemotherapy. Anesthetic management of HIPEC is further impacted by these developments. In addition to the ambitious, long-lasting surgery, HIPEC causes significant fluid, blood and protein losses, increased intra-abdominal pressure, systemic hyperthermia, and increased metabolic rate, leading to relevant pathophysiological alterations, and therefore represents a challenge for anesthetist and critical care physicians. SUMMARY: Anesthetic management importantly contributes to the containment of the perioperative complications of HIPEC. An appreciation of the technical aspects and physiologic disruptions associated with intra-abdominal HIPEC is critical to ensure effective anesthetic management. Although data on this specialized surgical procedure are scarce, some referral centers have accumulated extensive experience. This article reviews the current knowledge about the anesthesiological and intensive care management of patients undergoing HIPEC. It pinpoints strategies for perioperative monitoring as well as illustrates alterations in hemodynamic, hematopoetic, and fluid hemostasis.