Anaesthesia-related complications and side-effects in TAVI: a retrospective study in Germany

Objectives This study was performed to analyse anaesthesia-related complications and side effects in patients undergoing transcatheter aortic valve implantation (TAVI) under general anaesthesia. Design Retrospective study. Setting The study was performed as a single-centre study in a hospital of tertiary care in Germany. Participants All 853 patients, who underwent TAVI at the Universitatsklinikum Regensburg between January 2009 and July 2015, were included. 52.5% were female patients. Primary and secondary outcome measures We gathered information, such as recent illness, vital parameters and medication administered during the intervention and postoperatively for 12 hours. We analysed all anaesthesia-related complications and anaesthesia-related side effects that occurred during the intervention and entire hospital stay. Results We analysed all 853 TAVI procedures. The mean patient age was 79 +/- 6 years. In 99.5% of cases, we used volatile-based anaesthesia. 2.8% (n=24; transfemoral (TF): n=19 [3.8%]; transapical (TA): n=5 [1.4%]) of all cases suffered from anaesthesia-related complications. 819 (TF: n=447; TA: n=372) anaesthesia-related side effects occurred in 586 (68.7%, TF: n=325 [64.2%], TA: n=261 [75.2%]) patients. Neither the complications nor the side effects had any serious consequences. Intraoperative hypothermia in 44% of cases (TF: n=202 [39.9%]; TA: n=173 [49.9%]) and postoperative nausea and vomiting in 27% (n=232; TF: n=131 [25.9%], TA: n=101 [29.1%]) of cases were the most common anaesthesia-related side effects. Conclusion In this study, serious anaesthesia-related complications were rarely seen, and non-critical anaesthesia-related side effects could have been avoided through consistent prophylaxis and management. Therefore, despite their high anaesthetic risk, general anaesthesia is justifiable in patients who underwent TAVI

Left ventricular support adjustment to aortic valve opening with analysis of exercise capacity

Background LVAD speed adjustment according to a functioning aortic valve has hypothetic advantages but could lead to submaximal support. The consequences of an open aortic valve policy on exercise capacity and hemodynamics have not yet been investigated systematically. Methods Ambulatory patients under LVAD support (INCOR®, Berlin Heart, mean support time 465 ± 257 days, average flow 4.0 ± 0.3 L/min) adjusted to maintain a near normal aortic valve function underwent maximal cardiopulmonary exercise testing (CPET) and right heart catheterization (RHC) at rest and during constant work rate exercise (20 Watt). Results Although patients (n = 8, mean age 45 ± 13 years) were in NYHA class 2, maximum work-load and peak oxygen uptake on CPET were markedly reduced with 69 ± 13 Watts (35% predicted) and 12 ± 2 mL/min/kg (38% predicted), respectively. All patients showed a typical cardiac limitation pattern and severe ventilatory inefficiency with a slope of ventilation to carbon dioxide output of 42 ± 12. On RHC, patients showed an exercise-induced increase of mean pulmonary artery pressure (from 16 ± 2.4 to 27 ± 2.8 mmHg, p < 0.001), pulmonary artery wedge pressure (from 9 ± 3.3 to 17 ± 5.3 mmHg, p = 0.01), and cardiac output (from 4.7 ± 0.5 to 6.2 ± 1.0 L/min, p = 0.008) with a corresponding slight increase of pulmonary vascular resistance (from 117 ± 35.4 to 125 ± 35.1 dyn*sec*cm−5, p = 0.58) and a decrease of mixed venous oxygen saturation (from 58 ± 6 to 32 ± 9%, p < 0.001). Conclusion An open aortic valve strategy leads to impaired exercise capacity and hemodynamics, which is not reflected by NYHA-class. Unknown compensatory mechanisms can be suspected. Further studies comparing higher vs. lower support are needed for optimization of LVAD adjustment strategies

Butyrylcholinesterase as a perioperative complication marker in patients after transcatheter aortic valve implantation: a prospective observational study

Objectives Transcatheter aortic valve implantation (TAVI) is performed in elderly patients with severe aortic valve stenosis and increased operative risks. We tested the hypothesis that acetylcholinesterase (AChE) and butyrylcholinesterase (BChE) have a predictive value for prevalent complications after TAVI and could serve as indicators of systemic inflammation in the early postoperative period

A review of epidural simulators: Where are we today?

Thirty-one central neural blockade simulators have been implemented into clinical practice over the last thirty years either commercially or for research. This review aims to provide a detailed evaluation of why we need epidural and spinal simulators in the first instance and then draws comparisons between computer-based and manikin-based simulators. This review covers thirty-one simulators in total; sixteen of which are solely epidural simulators, nine are for epidural plus spinal or lumbar puncture simulation, and six, which are solely lumbar puncture simulators. All hardware and software components of simulators are discussed, including actuators, sensors, graphics, haptics, and virtual reality based simulators. The purpose of this comparative review is to identify the direction for future epidural simulation by outlining necessary improvements to create the ideal epidural simulator. The weaknesses of existing simulators are discussed and their strengths identified so that these can be carried forward. This review aims to provide a foundation for the future creation of advanced simulators to enhance the training of epiduralists, enabling them to comprehensively practice epidural insertion in vitro before training on patients and ultimately reducing the potential risk of harm. © 2013 IPEM

Benefits in therapy with the tyrosinkinase-inhibitor of the epidermal growth factor receptor (erlotinib) among patients with non small-cell lung cancer

In der vorliegenden Studie wurde untersucht, ob sich bei Patienten mit Bronchialkarzinom durch eine Second-Line-Chemotherapie mit dem Tyrosinkinaseinhibitor Erlotinib ein Nutzen erzielen lässt. Dabei wurde besonderes Augenmerk auf Faktoren gelegt, die das progressionsfreie Überleben bei diesen Patienten möglicherweise beeinflussen können. Grundlage der Untersuchungen bildete ein Probanden- kollektiv von 42 Patienten, die sich mit der Diagnose nicht-kleinzelliges Bronchialkarzinom bis zum 31.12.2007 einer Second-Line-Chemotherapie mit Erlotinib unterzogen. Zu diesem Stichtag lagen für 23 Patienten Todesdaten vor. Das mediane progressionsfreie Überleben für alle untersuchten 42 Patienten betrug 3,88 Monate, wobei sich die Spanne von 0 bis 21 Monate erstreckte. Im Gesamten zeigten 59,52% der Patienten ein Ansprechen, das heißt, das progressionsfreie Überleben dauerte länger als einen Monat. Folgende allgemeine Patientenmerkmale wurden aus den Krankenblättern erhoben: Geschlecht, Alter, histologische Tumordiagnose, Tumorstadium nach Stadieneinteilung durch die TNM-Klassifikation, Metastasensorte soweit Metastasen vorlagen, Zeitpunkt der Erstdiagnose, Rauchverhalten, Allgemeinzustand nach Karnofsky-Index, Vorerkrankungen, Begleitmedikation, ausgewählte Laborwerte sowie Zeitraum und Art der First-Line-Therapie. Was die Second-Line-Therapie unter Erlotinib betrifft, so wurden hier gezielt im Verlauf die aktuelle Dosis, Änderungen der Begleittherapie, Allgemeinzustand nach Karnofsky-Index, Toxizität (besonderes Augenmerk verdienten Nebenwirkungen an der Haut und im Gastrointestinaltrakt), Auffälligkeiten von einigen Laborwerten und das Tumorverhalten untersucht. Zum Abschluss wurden das Ende der Erlotinibtherapie, Grund des Absetzens, aktueller Stand, eventuell im Anschluss an die Erlotinibtherapie durchgeführte Therapien sowie im Falle des Todes der Todeszeitpunkt erfasst. Im Gesamtüberblick konnten somit das progressionsfreie Überleben unter Erlotinib, die Einnahmedauer des Tyrosinkinaseinhibitors und das absolute Überleben seit der Erstdiagnose festgestellt werden. Hauptziel der Untersuchung war es, herauszufinden, inwiefern unsere Patienten unter Erlotinib im Sinne einer Verlängerung ihres progressionsfreien Überlebens profitieren und welche Faktoren die Ansprechrate beeinflussen. Der Einfluss ausgewählter Merkmale wurde statistisch untersucht. Im Vergleich mit Angaben in der Literatur konnte für das untersuchte Probandenkollektiv eine repräsentative Verteilung der Patientenmerkmale ermittelt und somit eine gewisse Relevanz der Ergebnisse dieser Studie angenommen werden. Statistisch signifikante Unterschiede ergaben sich für folgende Faktoren: Einnahmedauer, Krankheitsverhalten bei Therapiebeginn, Karnofsky-Index während der Behandlung, Nebenwirkungen an der Haut sowie Veränderungen in der Serumchemie. Nonresponder nahmen folglich Erlotinib wie erwartet statistisch signifikant kürzer ein, zeigten zu Beginn der Erlotinibtherapie statistisch signifikant häufiger ein fortschreitendes Krankheitsgeschehen, wiesen während der Therapie statistisch signifikant häufiger einen schlechteren Karnofsky-Index auf, erlitten statistisch signifikant weniger häufig schwere Nebenwirkungen an der Haut (Grad 3 und 4) und ihnen waren statistisch signifikant häufiger Serumwertveränderungen zuzuschreiben. Das prognostische Hauptmerkmal, das sowohl bei unserem Patientengut als auch in der Literatur signifikante Bedeutung hat, ist wohl, dass Responder statistisch signifikant häufiger schwere Nebenwirkungen an der Haut erleiden. Da Auftreten und Schweregrad von follikulären Ekzemen also mit einem positiven Ansprechen von Erlotinib korreliert sind, könnte es vielleicht nützlich sein, wenn man bereits vor Beginn der Erlotinibtherapie vorhersagen könnte, wie wahrscheinlich Patienten solche Nebenwirkungen entwickeln werden. Insgesamt kann man sagen, dass der Einsatz dieser molekular zielgerichteten Substanz zu einer Erweiterung der Therapiemöglichkeiten im palliativen Setting bei Bronchialkarzinompatienten geführt hat. Die Behandlung mit Erlotinib bedeutet ein Benefit für das Gesamtüberleben und das progressionsfreie Überleben bei Patienten mit fortgeschrittenem Bronchialkarzinom, die im Voraus eine Chemotherapie erhalten hatten. Dieses Benefit beschränkt sich nicht auf klinische Subgruppen wie weibliches Geschlecht, Adenokarzinom in der Histologie und Nichtraucher. Diese klinischen Parameter allein sind wohl folglich nicht ausreichend, um Patienten im Vornherein zu identifizieren, die wahrscheinlich von der Therapie profitieren. Vielmehr sind bessere Methoden notwendig, um möglicherweise voraussagen zu können, wer von dem Tyrosinkinaseinhibitor profitieren wird. Hoffnungen ruhen auf der Etablierung molekularer prognostischer und prädiktiver Marker in der klinischen Routine.The aim of this study was to examine if patients with nsclc benefit from a second-line chemotherapy with the tyrosinekinase-inhibitor erlotinib. The main focus was laid on those factors which possibly influence progression-free survival in these patients. The data was obtained from 42 patients with nsclc who had undergone a second-line chemotherapy with erlotinib until 31.12.2007. On this day 23 of these patients had already died. The median progression-free survival of all patients was 3,88 months, ranging from 0 to 21 months. 59,52% of the patients showed a response, defined as a progression-free survival longer than one month. The following parameters were collected form the patients’ files: sex, age, general condition (evaluated with the karnowski-index), past medical history, side medication, smoking behaviour, date of first diagnosis, tumor histopathology, TNM stage, metastases if present, selected laboratory parameters as well as firstline-therapy substances and time-frame. During second-line-chemotherapy with erlotinib data was analyzed concerning drug dosage, toxicity (especially adverse reactions of skin and gastrointestinal tract), abnormality of some laboratory parameters, tumor response, side medication, and general condition (evaluated with the karnowski-index). At the end of the therapy with erlotinib data collection was completed with the following: reason for stopping the treatment, actual status, and options of future treatment, or time of death if the patient had died. Overall, progression-free-survival under erlotinib treatment, duration of treatment with the tyrosinkinase-inhibitor and absolute survival since time of first diagnosis were recorded. In most of the patients these data could be completely developped. Main aim of the study was to find out to what extent the patients benefit from erlotinib in terms of prolongation of their progression-free survival and which factors influence the rate of response. The influence of selected parameters was analyzed statistically. In comparison to data in the literature there could be detected a representative distribution of the patients' features for the analysed patient-collective. Consequently, a relevance of the results of this study could be assumed. Statistically significant differences resulted from the following factors: duration of taking, characteristics of the illness at the beginning, karnowski-index during the treatment, adverse reactions of skin and abnormality of some laboratory parameters. Thus, treatment of nonresponders with erlotinib was statistically significant shorter, nonresponders showed statistically significant more often a progressive disease at the beginning of the therapy with erlotinib, had during therapy statistically significant more often a worse karnowski-index, suffered statistically significant less often from severe adverse effects of the skin (grade 3 and 4) and they were ascribed statistically significant more often abnomalities of some laboratory parameters. The prognostic main feature which has importance both in our patient-collective and in the literature is that responder suffer statistically significant more often from severe adverse effects of the skin. Since incidence and severity of follicular eczema correlate with a positive response to erlotinib, it might be useful to predict already before the beginning of therapy with erlotinib in what probability patients will develop such toxicity. In summary, the application of this molecular targeted substance in second-line therapy represents an additional option in palliative care of patients with advanced stage nsclc. Patients with advanced stage lung cancer, who had previously received chemotherapy, benefit from a treatment with erlotinib concerning overall survival and progression-free survival. This benefit does not depend on sex, histopathology or smoking behaviour. These clinical parameters alone are not sufficient to identify those patients beforehand who are likely to benefit from erlotinib therapy. In fact, other methods are necessary to predict which patients will potentially benefit from a therapy with the tyrosinkinase-inhibitor. Future research will hopefully help to establish molecular prognostic and predictive markers in the clinical routine