Purpose: Restoring Effective Sleep Time in Post Cardiac Surgery Patients: A Quality Improvement Project Brooke Watts, BSN, RN, DNP Student, Murray State University Dr. Kristin Reid, DNP, APRN, ACNS-BC, DNP Program Director/Assistant Professor Murray State University Aims: This quality improvement project was developed using DNP project guidelines provided through Murray State University and was designed to improve sleep in hospitalized cardiac surgery patients. Processes: IRB approval was obtained from the healthcare institution and academic institution. This two-phase quality improvement project was designed to analyze the effects of a change in normalized hospital routines on self-reported sleep in post-cardiac surgery patients. Phase one involved no change in unit nursing routines to draw baseline data. Phase two involved the quality improvement intervention where routine patient assessments and vital signs were executed at 11:00 p.m., and at 04:00 a.m. Any non-timed lab work or routine radiological studies were postponed until after 04:00am. Patient participation for both phase one (n=4) and phase two (n=3) were determined by exclusion criteria. The Richards Campbell Sleep Questionnaire (RCSQ) was utilized for data collection and patients were asked to complete the questionnaire daily. Results: Comparison of mean patient-reported sleep scores between the pre-intervention and intervention groups showed a positive association between the quality improvement intervention and patient reported sleep. Limitations: Limitations for this project included a small sample size in both phases. IRB stipulations required a low-risk profile which limited eligible participants. There was a limited timeframe for project execution due to time required for IRB approval and to meet course-related timelines. The project was further limited by lack of on-site dedicated project staff overseeing qualifying patient enrollment. Conclusions: Key findings were in alignment with sleep-related findings in comparable studies and projects where unit routines were adjusted. Execution of similar projects should occur to provide more substantial evidence supporting this quality change. With evidence of this project in mind, providers and nurses can practice mindfully and incorporate creative approaches to safely care for patients and improve sleep.

La thymectomie est un geste chirurgical fréquemment nécessaire lors des interventions cardiaques en période néonatale. Il est connu que la résection du thymus entraîne une lymphopénie ne semblant pas avoir de conséquences cliniques graves. La lymphopénie constatée serait plus importante chez les patients ayant eu une chirurgie cardiaque de type Fontan. Toutefois, on ignore si la lymphopénie est uniquement secondaire à la thymectomie ou si elle est liée à ce type particulier de chirurgie cardiaque. La présente recherche porte sur 19 patients opérés selon l'approche Fontan; ils ont été comparés à 6 patients "contrôle" ayant eu une thymectomie au cours d'une chirurgie cardiaque d'un autre type. Les résultats indiquent que les patients de type Fontan accusent une diminution du nombre de cellules naïves CD4+ et CD8+ et plus particulièrement une baisse de leurs émigrants thymiques (CD45RA+CD31+/CD4+). On note en contrepartie une expansion du répertoire mémoire (CD45RO+). Ces altérations lymphocytaires sont comparables aux contrôles. Il semble donc que les anomalies lymphocytaires relevées soient reliées principalement à la thymectomie et non pas au type de chirurgie. Les infections plus importantes chez les Fontan, quant à elles, pourraient s'expliquer par une évolution post-opératoire défavorable. / The thymectomy is a surgical procedure often done during cardiac surgery. It is well known that the resection of the thymus can cause alterations of lymphocyte subpopulations without major clinical consequences. This lymphopenia could be more pronounced in patients who undergone a cardiac surgery named "Fontan". Nevertheless, it is not known if these alterations are due to the thymectomy or this specific type of cardiac surgery. We recruited 19 patients with Fontan surgery and compared them to 6 patients who had a cardiac surgery of another type. Our results show decreased CD4+ and CD8+ naive T cells populations and more specifically, low numbers of thymic emigrants (CD45RA+CD31+/CD4+). Expansion of memory repertoire (CD45RO+) is also noted. These findings are also found in the control group. Thus, perturbations of T cells populations seem to be related to the thymectomy rather than the type of cardiac surgery. Infections were more severe in the Fontan group but they can be explained by an unfavourable post-operative evolution in this group of patients.

This thesis is focused on the nursing care for patient after valvular defects surgery. The aim of this final paper is to ascertain the principles of specialized nursing care for patient after valvular defects surgery, analyse the condition of written standards for providing aftercare to patients who underwent valvular defects surgery, or the state of the nursing protocols in specialized nursing care. The purpose of qualitative - observational research in providing specialized nursing care is to find an answer to the question of whether the specifics of nursing care in Prague cardiac centres are significantly different. The theoretical section contains chapters describing cardiac centres, the history of surgical treatment of heart valves, and the most common valvular heart defects in adulthood. In the theoretical section of this study, I focus in detail on the nursing care for patients following cardiac procedure, ensuring not to forget the monitoring of physiological functions, artificial pulmonary ventilation, and immediate position after elective cardiac surgery. The empirical section is divided into quantitative and qualitative research. The quantitative empirical investigation is focused on an anonymous questionary survey that has been applied in three Prague cardiac centres. Approximately 150...

Objetivo: Determinar as mudanças nas ondas dos potenciais evocados auditivos de tronco encefálico (PEATE) como indicador de integridade neural em eventos de hipoxia-isquemia cerebral em crianças submetidas à cirurgia cardíaca com circulação extracorpórea (CEC). Método: Participaram deste estudo 09 pacientes pediátricos com idade entre 0 a 2 anos, submetidos à cirurgia cardíaca de alta complexidade no Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto. A avaliação eletrofisiológica da audição foi realizada no centro cirúrgico do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, durante os respectivos momentos da cirurgia cardíaca: Sedação, Circulação Extracorpórea (CEC) e Hipotermia, e ao Final da Cirurgia, com o registro do potencial evocado auditivo de tronco encefálico (PEATE), por meio do equipamento Nicolet Endeavor CR, conectado a um notebook, duas sondas de espuma, 4 eletrodos de agulha, posicionados na mastóide direita e esquerda, vertex craniano e fronte. Resultados: As crianças tinham média de idade de 10 meses. Dessas 9 crianças, 3 do sexo feminino e 6 do sexo masculino, a média do peso foi de 6,0 Kg, as patologias e ou propostas cirúrgicas foram: Correção de Disfunção Valvar Aórtica e Tricúspide por Valvoplastia, Correção de Drenagem Anômola Total das Veias Pulmonares, Correção de Cor Triatriatum, Operação de Glenn, Implante de Marcapasso Cardíaco Intracavitário de Dupla Câmara, Correção de Disfunção Valvar Mitral por Valvoplastia, Fechamento de Comunicação Interatrial, Fechamento de Comunicação Interventricular, Bandagem e Correção da Persistência Canal Arterial. Duas dessas crianças possuem Síndrome de Down. Foi observado quanto às latências das ondas I, III e V, e seus interpicos da orelha direita e esquerda mudanças dos valores comparadas ao início com CEC e hipotermia, assim como ao início com o final da cirurgia, porém os valores foram estatisticamente não significantes, p > 0,05. Conclusão: Não foram encontradas alterações nas latências absolutas e na latência dos intervalos interpicos do PEATE para as situações de hipotermia e circulação extracorpórea. / Objective: To determine changes in the waves of brainstem evoked response audiometry (BERA) as an indicator of neural integrity in events of brain hypoxiaischemia in children undergoing cardiac surgery with cardiopulmonary bypass (CPB). Method: 09 pediatric patients aged 0 to 2 have taken part in this study, who were submitted to highly complex cardiac surgery at Hospital das Clínicas, Medical School of Ribeirão Preto. The electrophysiological assessment of hearing was performed at the surgical center of Hospital das Clínicas of the Medical School of Ribeirão Preto, during the respective moments of the cardiac surgery: Sedation, Extracorporeal Circulation (CPB) and Hypothermia, and at the End of Surgery, by recording the brainstem auditory evoked response (BERA), using the Nicolet Endeavor CR equipment, connected to a laptop, two foam probes, four needle electrodes positioned in the right and left mastoid, cranial vertex and forehead. Results: The mean age of the children was 10 months. Out of these 9 children, 3 were female and 6 were male, and their mean weight was 6.0 kg. The pathologies and or surgical proposals were: Correction of Aortic Valve Dysfunction and Tricuspid by valvuloplasty, Correction of total anomalous pulmonary venous drainage, Color Correction Triatriatum, Glenn Procedure, Double-chambered Intracavitary Cardiac Pacemaker Implantation, Mitral Valve Dysfunction Correction, Interatrial Communication Closure, Interventricular Communication Closure, Bandaging, and Correction of Persistent Arterial Canal. Two of these children have Down Syndrome. As for the latencies of the I, III and V waves and their interpeaks of the right and left ear, it was observed changes in values compared to the onset with CPB and hypothermia, as well as to the beginning with the end of surgery, but the values were not statistically significant, p > 0.05. Conclusion: No alterations were found in the absolute latencies and in the latency of the BERA intervals for situations of hypothermia and cardiopulmonary bypass.

Introdução: Estudos anteriores sugerem possível benefício do uso perioperatório das estatinas para redução de eventos cardiovasculares pósoperatórios. Metanálise previamente publicada demonstra que as estatinas reduzem mortalidade e infarto perioperatório em pacientes submetidos a cirurgia não-cardíaca. Entretanto, novas evidências em cirurgia cardíaca sugerem efeitos neutros ou mesmo deletérios das estatinas, sendo que metanálise recente demonstrou aumento da incidência de insuficiência renal aguda e tendência a maior mortalidade pós-operatória. Devido aos resultados conflitantes e escassez de evidências definitivas, foi realizada uma revisão sistemática e metanálise de estudos randomizados para avaliar os efeitos do uso perioperatório das estatinas em cirurgia cardíaca e nãocardíaca. Objetivo: Avaliar em pacientes adultos submetidos à cirurgia cardíaca e não-cardíaca a associação entre o uso perioperatório de estatinas e a incidência pós-operatória de infarto agudo do miocárdio, acidente vascular cerebral, insuficiência renal aguda e mortalidade. Metodologia: As bases de dados Pubmed, EMBASE e Cochrane foram avaliadas por 2 pesquisadores independentes até 1º de maio de 2018 para busca de artigos apropriados. Foram incluídos estudos randomizados que avaliaram o uso perioperatório de estatinas comparadas a placebo ou a nenhum tratamento em pacientes submetidos a cirurgia cardíaca e nãocardíaca. Foram calculados o risco relativo (RR) ou razão de chances (odds ratio, OR) e intervalo de confiança 95% (IC 95%) por meio de metanálise de efeitos fixos. Foi realizada a análise sequencial dos estudos (trial sequential analysis, TSA) para quantificar a confiabilidade estatística dos dados. A metodologia Cochrane foi utilizada. Os desfechos primários foram definidos como infarto agudo do miocárdio, acidente vascular cerebral, insuficiência renal aguda e mortalidade no período pós-operatório. Resultados: Foram incluídos 35 estudos randomizados totalizando 8200 pacientes. O uso de estatina comparado ao controle foi associado a menor incidência de infarto em pacientes submetidos a cirurgia não-cardíaca (OR=0,44 [IC 95%, 0,30 a 0,64], p < 0,0001), mas não em pacientes submetidos a cirurgia cardíaca (OR=0,93 [IC 95%, 0,70 a 1,24], p=0,61). O uso da estatina foi associado a maior incidência de insuficiência renal aguda em cirurgia cardíaca (RR=1,15 [IC 95%, 1,00 a 1,31], p=0,05), mas não em cirurgia não-cardíaca (RR=1,52 [IC 95%, 0,71 a 3,26], p=0,28). Não foi observado impacto do uso das estatinas na ocorrência de acidente vascular cerebral e mortalidade em ambos os grupos cirúrgicos. No entanto, a análise dos estudos com baixo risco de viés em cirurgia cardíaca demonstrou maior mortalidade com o uso de estatinas comparadas a placebo (OR=3,71 [IC 95%, 1,03 a 13,34], p=0,04). A análise sequencial dos estudos (TSA) não sugeriu conclusões definitivas sobre o assunto. Conclusão: As estatinas parecem ter efeito protetor contra infarto pós-operatório em cirurgia não-cardíaca, mas estão associadas a maior risco de insuficiência renal aguda em cirurgia cardíaca. Possíveis efeitos positivos ou negativos sobre a mortalidade não podem ser excluídos. Os dados dos estudos randomizados disponíveis até o momento ainda são insuficientes para conclusões definitivas sobre o uso perioperatório das estatinas. Estudos randomizados adicionais são necessários para avaliar o perfil de segurança e possíveis efeitos benéficos destas medicações nos desfechos pós-operatórios / Introduction: Previous studies supported potential beneficial effects of perioperative statin therapy to reduce postoperative complications. Accordingly, previous meta-analysis concluded that statin treatment decreases the perioperative incidence of mortality and myocardial infarction in non-cardiac surgery. In contrast, growing evidences on perioperative statins administration in cardiac surgery setting suggested neutral or even detrimental results. A recent systematic review and meta-analysis found that perioperative statin therapy in this population was associated with an increased incidence of postoperative acute kidney injury and a trend toward increased mortality. Due to the contrasting results and lack of definitive evidence, we performed a systematic review and meta-analysis of randomized controlled trials to examine the effects of perioperative statin therapy on postoperative outcomes in adult cardiac and non-cardiac surgery patients. Objective: To assess the association between perioperative statin therapy and postoperative myocardial infarction, stroke, acute kidney injury and mortality in patients submitted to cardiac and non-cardiac surgery. Methods: Pubmed, EMBASE, and Cochrane databases were searched through May 1st, 2018 for appropriate articles. Articles were independently assessed by 2 reviewers. Randomized controlled trials evaluating adult cardiac and non-cardiac surgery patients comparing perioperative statin therapy versus placebo or no treatment were included. Risk ratio (RR) or odds ratio (OR) and 95% confidence interval (CI) were obtained using fixedeffects meta-analyses. Trial sequential analysis (TSA) was performed to quantify the statistical reliability of data. The Cochrane methodology was used. Main outcomes were postoperative myocardial infarction, stroke, acute kidney injury, and mortality. Results: Data from 35 randomized controlled trials involving 8200 patients were included. Perioperative statin therapy was associated with lower incidence of postoperative myocardial infarction in noncardiac surgery compared to control (OR=0.44 [95% CI, 0.30 a 0.64], p < 0.0001), but not in cardiac surgery OR=0.93 [95% CI, 0.70 a 1.24], p=0.61). Higher incidence of acute kidney injury was evident in cardiac surgery patients receiving perioperative statins (RR=1.15 [95% CI, 1.00 a 1.31], p=0.05), but not in the non-cardiac surgery population (RR=1.52 [95% CI, 0.71 a 3.26], p=0.28). No difference in postoperative stroke and mortality was present in patients undergoing either cardiac or non-cardiac surgery. However, low risk of bias trials performed in cardiac surgery showed a higher mortality with statins versus placebo (OR=3.71 [95% CI, 1.03 a 13.34], p=0.04). Trial sequential analysis suggested no firm conclusions on the topic. Conclusions: Statins appear to be protective against postoperative myocardial infarction in non-cardiac surgery and associated with an increased risk of acute kidney injury in cardiac surgery. Possible positive or even negative effects on mortality could not be excluded. There is still insufficient randomized data for firm conclusions on perioperative statin therapy. Further randomized controlled trials should evaluate both the safety profile and possible effects on patients\' outcomes

Introdução: Aneurismas e dissecções da aorta constituem as principais doenças da aorta, as quais podem ser submetidas a princípios e técnicas de tratamento cirúrgico em comum. A conduta clínica e cirúrgica continua sendo um desafio nos procedimentos eletivos, bem como em casos de emergência. Informações sobre variáveis prognósticas associadas independentemente com óbito hospitalar e no longo prazo, são escassas, havendo necessidade da identificação destes fatores para a avaliação apropriada sobre o risco cirúrgico desta população. Objetivos: Primário: identificar variáveis prognósticas associadas independentes ao óbito hospitalar em pacientes submetidos a procedimento cirúrgico para correção de doenças da aorta. Secundários: identificar variáveis prognósticas associadas independentes ao óbito tardio e ao desfecho clínico composto (óbito, sangramento, disfunção ventricular e complicações neurológicas). Casuística e Métodos: Delineamento transversal com componente longitudinal, com coleta de dados retrospectiva e prospectiva. Pacientes consecutivos, portadores de aneurisma de aorta ascendente ou dissecção crônica de aorta tipo A de Stanford, foram incluídos por meio de revisão de prontuários. Foram incluídos 257 pacientes, cujos critérios de inclusão envolviam aqueles que foram operados por dissecção crônica de aorta tipo A de Stanford e aneurisma de aorta ascendente. Foram excluídos pacientes com dissecção aguda de aorta, de qualquer tipo, e pacientes que tiveram aneurisma de aorta em outro segmento da aorta que não fosse a aorta ascendente. Os desfechos clínicos avaliados foram óbito, sangramento clinicamente relevante, complicações neurológicas e disfunção ventricular, fase hospitalar e óbito no longo prazo. As variáveis prognósticas avaliadas incluíram: demografia, fatores pré-operatórios, fatores intra-operatórios e complicações pós-operatórias. O seguimento médio foi de 970 dias. O tamanho de amostra foi definido por conveniência aliado a publicações prévias sobre o tópico. Análise univariada foi realizada para selecionar variáveis para serem inseridas no modelo multivariado para identificação das variáveis prognósticas independentemente associados aos desfechos clinicamente relevantes. Resultados: As seguintes variáveis prognósticas apresentaram associação independente como o risco aumentado de óbito na fase hospitalar (RC; IC95%; P valor): etnia negra (6.8; 1.54-30.2; 0,04), doença cerebrovascular (10.5; 1.12-98.7; 0,04), hemopericárdio (35.1; 3.73-330.2; 0,002), cirurgia de Cabrol (9.9; 1.47-66.36; 0,019), cirurgia de revascularização miocárdica (4.4; 1.31-15.06; 0,017), revisão de hemostasia (5.72 ;1.29-25.29; 0,021) e circulação extra-corpórea [min] (1.016; 1.007-1.026; 0,001). A presença de dor torácia associou-se independentemente com o risco reduzido de óbito hospitalar (0.27; 0.08-0.94; 0,04). As seguintes variáveis apresentaram associação independente com o risco aumentado do desfecho clínico composto na fase hospitalar: uso de antifibrinolítico (3.2; 1.65-6.27; 0,0006), complicação renal (7.4; 1.52-36.0; 0,013), complicação pulmonar (3.7; 1.5-8.8; 0,004), EuroScore (1.23; 1.08-1,41; 0,003) e tempo de CEC [min] (1.01; 1.00-1.02; 0,027). As seguintes variáveis apresentaram associação independente com o risco aumentado de óbito no longo prazo: doença arterial obstrutiva periférica (7.5; 1.47-37.85; 0,015), acidente vascular cerebral prévio (7.0; 1.46-33.90; 0,015), uso de estatina na alta hospitalar (4.9; 1.17-21.24; 0,029) e sangramento aumentado nas primeiras 24 horas (1.0017; 1.0003-1.0032; 0,021). Conclusão: Etnia negra, doença cerebrovascular, hemopericárcio, cirurgia de Cabrol, revascularização miocárdica cirúrgica associada, revisão de hemostasia e tempo de CEC associaram-se independentemente com risco aumentado de óbito hospitalar. A presença de dor torácica associou-se independentemente com o risco reduzido de óbito hospitalar. Doença arterial obstrutiva periférica prévia, acidente vascular cerebral prévio, uso de estatina na alta hospitalar e sangramento aumentado nas primeiras 24 horas associaram-se independentemente com risco aumentado de óbito no prazo longo. Uso de antifibrinolítico, complicação renal, complicação pulmonar, EuroScore e tempo de CEC associaram-se independentemente com o risco aumentado de desfecho clínico composto hospitalar (óbito, sangramento, disfunção ventricular e complicações neurológicas). / Introduction: Both aortic aneurisms and dissections constitute the main aortic diseases, sharing common principles and surgical procedure approaches. Medical and surgical management are seen as a medical challenge concerning elective procedures as well as in emergency cases. Data on prognostic variables independently associated with both hospital and long term death are scarce, leading to a need for appropriate identification of those factors for proper surgical risk evaluation of this population. Objectives: Primary: to identify prognostic variables independently associated with hospital death in patients who underwent surgical procedures for aortic disease correction. Secondary: to identify prognostic variables independently associated with long term death and with composite clinical endpoint (death, bleeding, ventricular dysfunction and neurological complications). Methods: Cross-sectional design plus a longitudinal component, with a retrospective and prospective data collection. Consecutive patients, diagnosed with ascendant aortic aneurism or type A of Stanford aortic chronic dissection were included by means of hospital chart revision and data extraction. A total of 257 patients were recruited and eligibility criteria included those who underwent surgical procedures due to ascendant aortic aneurism or type A of Stanford aortic chronic dissection. Patients with acute aortic dissection and with aortic aneurism in a different segment location other than ascendant aorta were excluded. Clinical endpoints evaluated were death, clinically relevant bleeding, ventricular dysfunction and neurological complications, during the hospital phase and long-term death. Prognostic variables evaluated included: demography, pre-operative factors, intra-operative factors and post-operative complications. Mean follow up was of 970 days. Sample size estimation was defined by a convenience sample along with previous publications. Univariate analysis was conducted to select key variables to be inserted in the multivariate model and to identify the prognostic variables independently associated with clinically relevant endpoints. Results: The following prognostic variables have been identified as independently associated with increased risk of hospital death (OR; 95%IC; P value): black ethnicity (6.8; 1.54-30.2; 0,04), cerebrovascular disease (10.5; 1.12-98.7; 0,04), hemopericardium (35.1; 3.73-330.2; 0,002), Cabrol operation (9.9; 1.47-66.36; 0,019), associated coronary artery bypass graft (4.4; 1.31-15.06; 0,017), reoperation for bleeding (5.72; 1.29-25.29; 0,021) and cardiopulmonary bypass time (CPB) [min] (1.016; 1.007-1.026; 0,001). Presence of chest pain was independently associated with reduced risk of hospital death (0.27; 0.08-0.94; 0,04). The following variables were independently associated with increased risk of composite clinical endpoint during hospital phase: antifibrinolitic use (3.2; 1.65-6.27; 0,0006), renal failure (7.4; 1.52-36.0; 0,013), respiratory failure (3.7; 1.5-8.8; 0,004), EuroScore (1.23; 1.08-1,41; 0,003) and cardiopulmonary bypass time (CPB) [min] (1.01; 1.00-1.02; 0,027). The following variables were independently associated with increased risk of long term death: peripheral obstructive arterial disease (7.5;1.47-37.85;0,015), previous stroke (7.0;1.46-33.90;0,015), at discharge statin use (4.9;1.17-21.24;0,029) and first 24-hour increased bleeding (1.0017;1.0003-1.0032;0,021). Conclusion: Black ethnicity, cerebrovascular disease, hemopericadium, Cabrol operation, associated coronary artery bypass graft, reoperation for bleeding, and cardiopulmonary bypass time were associated with increased risk of hospital death. Presence of chest pain was associated with reduced risk of hospital death. Peripheral obstructive arterial disease, previous stroke, at discharge statin use and first 24-hour increased bleeding were associated with increase risk of long-term death. Use of antifibrinolitic, renal failure, respiratory failure, EuroScore and cardiopulmonary bypass time were associated with increased risk of hospital composite clinical endpoint (death, bleeding, ventricular dysfunction and neurological complications).

Qualitätsmanagementsysteme haben ihren Stellenwert in allen Bereichen der Industrie, der Dienstleistung und der Verwaltung bewiesen. Mittlerweile stellt der Nachweis über Qualitätsmanagementsysteme neben der Verpflichtung zur externen Qualitätssicherung für alle stationären Einrichtungen des Gesund-heitswesens eine gesetzliche Verpflichtung dar. Trotzdem ist das Bewusstsein über Notwendigkeit und Nutzen von Qualitätsmanagementsystem im medizini-schen Bereich noch eher gering ausgeprägt. Mit der DIN EN ISO 9001:2000 steht nach ihrer Revision ein universeller Leitfa-den für ein modernes prozess- und kundenorientiertes Qualitätsmanagement-system auch für die Anwendung im Gesundheitswesen zur Verfügung. Gegen-über speziell für das Gesundheitswesen entwickelten Qualitätsmanagementmo-dellen, die überwiegend auf Strukturqualität ausgerichtet sind, berücksichtigt die Norm nach ihrer Revision neben Aspekten der Strukturqualität und einem Schwerpunkt auf der Prozessqualität jetzt auch die Ergebnisqualität. Zudem ist mit der DIN EN ISO 9001:2000 als derzeit einzigem Verfahren auch eine Zertifi-zierung von Einzeleinrichtungen komplexer Großkliniken wie z.B. Universitätskli-niken möglich. In einem 18 Monate währenden Prozess konnte in der Klinik für Kardiovaskuläre Chirurgie der Charité als medizinischer Fakultät der Humboldt-Universität Berlin ein Qualitätsmanagementsystem eingerichtet werden und schließlich als erste universitäre herzchirurgische Klinik für den Geltungsbereich "Patientenbehand-lung und Klinische Forschung" nach DIN EN ISO 9001:2000 zertifiziert werden. Dieses setzte eine umfassende Revision der Strukturen, der Prozesse sowie der Ressourcenzuordnung unter Mitwirkung aller Mitarbeiter voraus. Durch die Einführung des Qualitätsmanagementsystems und die anschließende Zertifizierung konnten neben qualitativen Verbesserungen auf vielen Ebenen messbare Qualitätsverbesserungen und signifikante Einsparungen erreicht werden. Exemplarisch handelt es sich um: - Verbesserungen der Zufriedenheit zuweisender Ärzte mit der Erreichbarkeit der Klinik durch Umstrukturierungen und Verbesserung der Infrastruktur so-wie Information der zuweisenden Ärzte. - Steigerung der Kodierqualität durch Anstieg der verschlüsselten Diagnosen um 135,3 % zwischen 2000 und 2002; hierdurch würden bei Anwendung des DRG-Systems durchschnittlich 78 % der Patienten in der höher vergüte-ten Fallpauschale des höchsten Schweregrades eingruppiert. - Reduktion des medizinischen Sachbedarfs um 3,3 % pro Operation mit Herz-Lungenmaschine durch geplante Ressourcenverteilung unter Bildung einer Schnittstelle zu einem externen Berater und monatlicher Analyse der aufgewandten Kosten für medizinischen Sachbedarf. - Reduktion der Laborkosten der Klinik um 35 % durch Einführung verbindli-cher Laborstandards für die perioperative Anforderung von Laboruntersu-chungen. Die Kosten, die mit der Einführung des Qualitätsmanagementsystems verbun-den waren konnten alleine durch die Reduktion der Ausgaben im Bereich des medizinischen Sachbedarfs sowie der Laborleistungen bereits innerhalb der ersten zwei Jahre eingespart werden; dies deckt sich mit den Erfahrungen an-derer Kliniken. Die Einführung eines Qualitätsmanagementsystems und dessen Zertifizierung nach DIN EN ISO 9001:2000 in einer herzchirurgischen Universitätsklinik ist somit möglich und kann zu messbaren Qualitätsverbesserungen sowie zu signi-fikanten Einsparungen durch geplanten Einsatz von Ressourcen führen. Sie schafft ein Bewusstsein für Qualität und kann den Weg zu einem Qualitätsma-nagementsystem für die Gesamtklinik erleichtern. Die erforderlichen Maßnah-men zum Erhalt des Qualitätsmanagementsystems können in einen kontinuierli-chen Verbesserungsprozess münden. / Quality management systems have proven to be effective tools in all areas of industry, service and administration. Although there is a legal obligation for the proof of a quality management system as well as for the participation in external quality assurance programs for all units of health care the consciousness for their need and usefulness ist low. After revision of EN ISO 9001:2000 there is a universal standard for a modern process and customer oriented quality management system for the application in all fields of health care. In contrast to quality modells especially designed for health care with focus on structure quality this standard integrates aspects of process quality and results. EN ISO 9001:2000 is the only standard which allows certification of part units of complex clinics like university hospitals. In a process of 18 months a quality management system could be introduced in the Department of Cardiovascular Surgery of the Charité epresenting the medi-cal faculty of Humboldt University Berlin leading to certification according to EN ISO 9001:2000 with the scope "Patient treatment and clinical research". Prior to this a comprehensive revision of structures, processes and the allocation of ressources with participation of all employees was necessary. By the introduction of this quality management system and the following certifi-cation quality improvements could be achieved: - Improvement of satisfaction of advising physicians with respect to the ac-cessibility of the department by modification of the structure and communica-tion systems as well as information of cooperating partners. - Improvement of the quality of the medical documentation by increase of coded side diagnoses by 135.3 % from 2000 to 2002. In the new DRG-system 78 % of all patients would be classified in the group of highest reim-bursement. - Reduction of medical goods by 3.3 % per operation with heart lung machine by means of planned allocation of ressources using an interface to external advisors and monthly analysis of costs for medical goods. - Reduction of laboratory costs by 35 % after introduction of panels for perio-perative routine laboratory investigations. In agreement with the experience of other clinics the costs for the introduction of the quality management system could be saved within the first years by the reduction of costs for medical goods and laboratory investigations. In conclusion the introduction of a quality management system and certification according to EN ISO 9001:2000 in a university cardac surgery department is possible and may lead to measurable quality improvements as well as to signifi-cant reduction of costs. It creates a consciousness for quality and may lead to a quality management system for the complete university clinic. The measures necessary for preservation of the quality management system may lead to a process of continuous quality improvement.

Die transmyokardiale Laserrevaskularisation ist ein chirurgisches Therapieverfahren, das als ultma ratio bei Patienten mit schwerster diffuser koronarer Herzerkrankung eingesetzt wird. Es führt bei der Mehrzahl der operierten Patienten zu einem signifikanten Rückgang des Angina-pectoris-Syndroms und einer deutliche Steigerung der physischen Leistungsfähigkeit. Dieser Effekt hält offensichtlich mehrere Jahre an. Nach unseren Erfahrungen ist eine transmyokardiale Laserrevaskularisation dann relativ gefahrlos wiederholbar. Eine Zunahme der Myokardperfusion oder der myokardialen Kontraktilität in den laserbehandelten Arealen konnte bislang nicht sicher nachgewiesen werden. Ebenso wurde bislang nicht belegt, daß die myokardiale Kontraktilität in den TMLR-Gebieten postoperativ ansteigt. Eine präoperativ bestehende Diabetes mellitus ist möglicherweise ein Risikofaktor für eine erhöhte Sterblichkeit im ersten Jahr nach TMLR und eine geringere Wahrscheinlichkeit, von der Operation hinsichtlich des Angina-pectoris-Syndroms zu profitieren. Im Einklang mit zahlreichen anderen Arbeitsgruppen gehen wir nach histologischer Analyse der Herzen verstorbener TMLR-Patienten davon aus, daß sich transmyokardiale Laserkanäle im frühen postoperativen Verlauf wieder verschließen. In der Umgebung der Laserkanäle setzt in der Folgezeit eine ausgeprägte Angioneogenese ein, die möglicherweise durch den spezifischen Effekt der Laserstrahlung mitunter ein erhebliches Ausmaß erlangen kann. Diese Angioneogenese könnte durchaus den Hauptwirkmechanismus der TMLR darstellen. Durch eine TMLR mit dem CO2-Laser kommt es nicht zu einer nennenswerten Zerstörung von kontraktilem Myokard. / Transmyocardial laser revascularization (TMR) has been increasingly used during the past years in patients suffering from severe diffuse coronary artery disease. The therapy is based upon the creation of transmyocardial channels in the free wall of the left ventricle by means of a laser. Several prospective, controlled, randomized studies were able to show that after TMR 70% of the patients operated on experienced a marked decline in angina symptoms and an increase in physical endurance and quality of life. These effects seem o last for years, and a TMR procedure can then be repeated. Whereas the regional and global myocardial function seems not to be influenced by transmyocardial laser revascularization, the question of an improvement in myocardial perfusion is still unanswered. Diabetic patients seem to be less likely to respond to the laser treatment and to carry a significant higher risk for death during the first postoperative year. Like several other study groups we found the TMR channels created by a CO2 laser closed by fibrin clots, erythrocytes and macrophages in the first postoperative days. There were no connections obvious between the channels and the ventricular cavity. Within the surrounding of the channels, however, we observed a marked neoangiogenesis. Induction of angioneogenesis seems to by the underlying principle of TMR. CO2 laser TMR does not result in significant injury to the myocardium.

Qualitätsmanagementsysteme haben ihren Stellenwert in allen Bereichen der Industrie, der Dienstleistung und der Verwaltung bewiesen. Mittlerweile stellt der Nachweis über Qualitätsmanagementsysteme neben der Verpflichtung zur externen Qualitätssicherung für alle stationären Einrichtungen des Gesundheitswesens eine gesetzliche Verpflichtung dar. Trotzdem ist das Bewusstsein über Notwendigkeit und Nutzen von Qualitätsmanagementsystem im medizinischen Bereich noch eher gering ausgeprägt. Mit der DIN EN ISO 9001:2000 steht nach ihrer Revision ein universeller Leitfaden für ein modernes prozess- und kundenorientiertes Qualitätsmanagementsystem auch für die Anwendung im Gesundheitswesen zur Verfügung. Gegenüber speziell für das Gesundheitswesen entwickelten Qualitätsmanagementmodellen, die überwiegend auf Strukturqualität ausgerichtet sind, berücksichtigt die Norm nach ihrer Revision neben Aspekten der Strukturqualität und einem Schwerpunkt auf der Prozessqualität jetzt auch die Ergebnisqualität. Zudem ist mit der DIN EN ISO 9001:2000 als derzeit einzigem Verfahren auch eine Zertifizierung von Einzeleinrichtungen komplexer Großkliniken wie z.B. Universitätskliniken möglich. In einem 18 Monate währenden Prozess konnte in der Klinik für Kardiovaskuläre Chirurgie der Charité als medizinischer Fakultät der Humboldt-Universität Berlin ein Qualitätsmanagementsystem eingerichtet werden und schließlich als erste universitäre herzchirurgische Klinik für den Geltungsbereich "Patientenbehandlung und Klinische Forschung" nach DIN EN ISO 9001:2000 zertifiziert werden. Dieses setzte eine umfassende Revision der Strukturen, der Prozesse sowie der Ressourcenzuordnung unter Mitwirkung aller Mitarbeiter voraus. Durch die Einführung des Qualitätsmanagementsystems und die anschließende Zertifizierung konnten neben qualitativen Verbesserungen auf vielen Ebenen messbare Qualitätsverbesserungen und signifikante Einsparungen erreicht werden. Exemplarisch handelt es sich um: - Verbesserungen der Zufriedenheit zuweisender Ärzte mit der Erreichbarkeit der Klinik durch Umstrukturierungen und Verbesserung der Infrastruktur sowie Information der zuweisenden Ärzte. - Steigerung der Kodierqualität durch Anstieg der verschlüsselten Diagnosen um 135,3 % zwischen 2000 und 2002; hierdurch würden bei Anwendung des DRG-Systems durchschnittlich 78 % der Patienten in der höher vergüteten Fallpauschale des höchsten Schweregrades eingruppiert. - Reduktion des medizinischen Sachbedarfs um 3,3 % pro Operation mit Herz-Lungenmaschine durch geplante Ressourcenverteilung unter Bildung einer Schnittstelle zu einem externen Berater und monatlicher Analyse der aufgewandten Kosten für medizinischen Sachbedarf. - Reduktion der Laborkosten der Klinik um 35 % durch Einführung verbindlicher Laborstandards für die perioperative Anforderung von Laboruntersuchungen. Die Kosten, die mit der Einführung des Qualitätsmanagementsystems verbunden waren konnten alleine durch die Reduktion der Ausgaben im Bereich des medizinischen Sachbedarfs sowie der Laborleistungen bereits innerhalb der ersten zwei Jahre eingespart werden; dies deckt sich mit den Erfahrungen an-derer Kliniken. Die Einführung eines Qualitätsmanagementsystems und dessen Zertifizierung nach DIN EN ISO 9001:2000 in einer herzchirurgischen Universitätsklinik ist somit möglich und kann zu messbaren Qualitätsverbesserungen sowie zu signifikanten Einsparungen durch geplanten Einsatz von Ressourcen führen. Sie schafft ein Bewusstsein für Qualität und kann den Weg zu einem Qualitätsmanagementsystem für die Gesamtklinik erleichtern. Die erforderlichen Maßnahmen zum Erhalt des Qualitätsmanagementsystems können in einen kontinuierlichen Verbesserungsprozess münden. / Quality management systems have proven to be effective tools in all areas of industry, service and administration. Although there is a legal obligation for the proof of a quality management system as well as for the participation in external quality assurance programs for all units of health care the consciousness for their need and usefulness ist low. After revision of EN ISO 9001:2000 there is a universal standard for a modern process and customer oriented quality management system for the application in all fields of health care. In contrast to quality modells especially designed for health care with focus on structure quality this standard integrates aspects of process quality and results. EN ISO 9001:2000 is the only standard which allows certification of part units of complex clinics like university hospitals. In a process of 18 months a quality management system could be introduced in the Department of Cardiovascular Surgery of the Charit頲epresenting the medi-cal faculty of Humboldt University Berlin leading to certification according to EN ISO 9001:2000 with the scope "Patient treatment and clinical research". Prior to this a comprehensive revision of structures, processes and the allocation of ressources with participation of all employees was necessary. By the introduction of this quality management system and the following certifi-cation quality improvements could be achieved: - Improvement of satisfaction of advising physicians with respect to the ac-cessibility of the department by modification of the structure and communica-tion systems as well as information of cooperating partners. - Improvement of the quality of the medical documentation by increase of coded side diagnoses by 135.3 % from 2000 to 2002. In the new DRG-system 78 % of all patients would be classified in the group of highest reim-bursement. - Reduction of medical goods by 3.3 % per operation with heart lung machine by means of planned allocation of ressources using an interface to external advisors and monthly analysis of costs for medical goods. - Reduction of laboratory costs by 35 % after introduction of panels for perio-perative routine laboratory investigations. In agreement with the experience of other clinics the costs for the introduction of the quality management system could be saved within the first years by the reduction of costs for medical goods and laboratory investigations. In conclusion the introduction of a quality management system and certification according to EN ISO 9001:2000 in a university cardac surgery department is possible and may lead to measurable quality improvements as well as to signifi-cant reduction of costs. It creates a consciousness for quality and may lead to a quality management system for the complete university clinic. The measures necessary for preservation of the quality management system may lead to a process of continuous quality improvement.

Objetivo: avaliar a eficácia da aplicação do teste de respiração espontânea (TRE) em predizer o sucesso da extubação em crianças com cardiopatia congênita no pósoperatório de cirurgia cardíaca, comparando-se com a aplicação do protocolo de desmame atualmente utilizado em centro de terapia intensiva pediátrico de hospital terciário. Desenho do estudo: ensaio clínico prospectivo randomizado controlado Pacientes: Foram elegíveis para o estudo pacientes de 0 a 18 anos de idade, no pósoperatório de cirurgia cardíaca para correção de cardiopatias congênitas, submetidos à ventilação mecânica (VM) pós-operatória por > 12 horas. Métodos: Os pacientes foram avaliados por um médico da equipe e os considerados aptos ao desmame foram selecionados para o estudo. Os pacientes randomizados ao grupo intervenção foram submetidos ao TRE (com PS de 10 cm H2O, PEEP de 5 cm H2O e FiO2 <= 50%, durante duas horas). Este teste foi realizado com ventilação em CPAP+PS. Os pacientes do grupo controle seguiram o desmame ventilatório de acordo com o protocolo vigente no CTIP do HCFMRP/USP. O desfecho primário foi considerado o sucesso da extubação, avaliado pela necessidade ou não de reintubação nas primeiras 48 horas após a extubação. Os desfechos secundários foram a duração da internação na UTI e no hospital, a incidência de pneumonia associada à ventilação e a mortalidade. Resultados: Foram alocadas no estudo 110 crianças (54 no grupo controle e 56 no grupo intervenção). Os dados demográficos, clínicos, as características cirúrgicas e os escores de gravidade, complexidade cirúrgica e de disfunção orgânica foram semelhantes nos dois grupos. Os pacientes submetidos ao TRE comparados ao grupo controle apresentaram maior sucesso de extubação (83% vs. 68.5%, p=0,02) e menor tempo de internação no CTIP (mediana 85 h vs. 367 h, p< 0,0001), respectivamente. Não houve diferença significativa entre os grupos no tempo de internação hospitalar, incidência de pneumonia associada à ventilação e mortalidade. Conclusões: O estudo mostra que o TRE é uma importante ferramenta de avaliação de prontidão à extubação. Os pacientes que foram alocados ao grupo de intervenção apresentaram maior sucesso de extubação e menor tempo de internação na UTI. / Objective: To evaluate the efficacy of the spontaneous breathing test (SBT) in predicting the success of extubation in children with congenital heart disease in the postoperative period of cardiac surgery compared with the application of the weaning protocol currently used in a pediatric intensive care unit. Study design: randomized controlled trial. Patients: Patients 0 to 18 years of age in the postoperative period following congenital heart surgery and on, mechanical ventilation (MV) for> 12 hours were eligible for the study. Methods: Patients were evaluated by a staff physician and those considered ready for weaning were selected for the study. Patients randomized to the intervention group underwent the SBT (with PS of 10 cm H2O, PEEP of 5 cm H2O and FiO2 <= 50% for two hours). This test was performed with CPAP + PS ventilation. The patients in the control group underwent ventilator weaning according to the current protocol in the PICU. The primary endpoint was success of extubation, defined as no need for reintubation in the first 48 hours following extubation. Secondary outcomes were duration of PICU and hospital stay, incidence of ventilator-associated pneumonia, and mortality. Results: 110 children (54 in the control group and 56 in the intervention group) were included in the study. Demographic, clinical, surgical, and severity scores, surgical complexity, and organ dysfunction were similar in both groups. Patients submitted to SBT compared to the control group had greater extubation success (83% vs. 68.5%, p = 0.02) and shorter length of stay in the PICU (median 85 h vs. 367 h, p <0.0001), respectively. There was no significant difference between the groups in length of hospital stay, incidence of ventilator-associated pneumonia and mortality. Conclusions: The study shows that the SBT is an important tool for assessment of extubation readiness. Patients who were allocated to the intervention group had greater extubation success and shorter PICU stay.