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PURPOSE: Hemothorax, the collection of blood in the intrapleural space, commonly arises in patients suffering from thoracic trauma. Fluid collections in this space can compromise cardiac and respiratory function and if left untreated, can result in hypovolemic crisis. Fluid is often successfully drained via a tube thoracostomy, in which an intercostal drain is inserted into the pleural space. If residual blood remains, however, clotting may occur and result in a retained hemothorax (RH). Intrapleural administration of tissue plasminogen activator (tPA), a fibrinolytic drug typically utilized in ischemic stroke, has been shown to be both a safe and effective technique to hydrolyze RH clots and reduce the need for more invasive surgical interventions. The present study aims to evaluate the safety and efficacy of tPA administration at Boston Medical Center (BMC) and compare this data to those of prior studies. This study will also investigate if tPA as a definitive treatment for RH, could reduce the need for additional interventions such as surgical procedures including Video-Assisted Thoracoscopic Surgery (VATS) and/or invasive thoracaotomy. Hospital/intensive care unit (ICU) lengths of stay (LOS), ventilator time, and complication rates will be used to determine if tPA may allow for a significant decrease in patient cost and burden of care versus surgery. An analysis of patient demographics and injury data will be used to determine the individual factors that could be used to predict the success of tPA as a definitive treatment. Using evidence-based treatment protocols, the aforementioned data will be critically evaluated to determine the appropriate timing and sequential positioning of tPA administration in the treatment algorithm for retained hemothorax. METHODS: A single-institution retrospective chart review was conducted of patients treated for traumatic pneumohemothorax by the Department of Acute Care and Trauma Surgery at Boston Medical Center. A study on predictive factors of the development of retained hemothorax included all such patients that presented to the emergency department (ED) between May 2014 and June 2016. Demographic and injury characteristics were analyzed to determine if patients from specific groups or with specific injuries are more prone to develop RH. To evaluate the safety of intrapleural tissue plasminogen activator, the incidence of complications such as post-trauma infection and mortality were determined in patients that were administered tPA to resolve retained hemothorax between May 2014 through December 2016. Next, utilizing an expanded data set, the efficacy of tPA was evaluated by determining the percentage of cases in which tPA was able to definitively resolve RH. Secondary efficacy data including average hospital length of stay, average ICU length of stay, average mechanical ventilation time, and rate of readmission were compared between various interventions as well. Finally, to elucidate the risk factors for RH and independent predictors of tPA as a definitive treatment, demographic data including age, ethnicity, and gender as well as injury data including mechanism of injury, the presence or absence of multisystem trauma, and the presence or absence of specific injuries such as rib fracture, pulmonary contusion, or diaphragmic insult were collected. RESULTS: A statistically significant positive correlation was observed between the likelihood of developing RH and both abdominal alimentary tract and extremity injuries, indicating that these injuries may serve as predictive factors for RH development. In a study investigating the safety of intrapleural tPA, there was no statistically significant difference in post-trauma infection rates between individuals treated with tPA and those who were not. Additionally, tPA treatment was associated with a lower mortality rate. Efficacy studies revealed that tPA therapy was associated with a statistically significant decrease in mechanical ventilation time, as compared to surgical intervention, however, tPA carried a RH resolution rate of just 43% with one patient experiencing a major adverse systemic reaction to the drug. Finally, demographic and injury data were analyzed to determine predictive factors of tPA success, but no statistically significant relationships were observed between any of these characteristics and the outcome of tPA therapy. CONCLUSION: Intrapleural tPA is a safe and effective alternative to more invasive surgical procedures. The success rate of tPA therapy in the present study was less than previous studies have indicated, however, the potential decreased ventilation time is important for preventing ventilator associated pneumonia (VAP) and the high rate of mortality it carries. Although the success rate is lower than expected, tPA should still be considered in the RH treatment protocol, prior to surgery, to decrease required ventilation time and potentially prevent the need for more invasive interventions with higher costs, morbidity, mortality rates, and patient burden.

京都大学 / 0048 / 新制・課程博士 / 博士(医学) / 甲第21338号 / 医博第4396号 / 新制||医||1031(附属図書館) / 京都大学大学院医学研究科医学専攻 / (主査)教授 坂井 義治, 教授 平井 豊博, 教授 溝脇 尚志 / 学位規則第4条第1項該当 / Doctor of Medical Science / Kyoto University / DFAM

京都大学 / 0048 / 新制・課程博士 / 博士(医学) / 甲第21620号 / 医博第4426号 / 新制||医||1033(附属図書館) / 京都大学大学院医学研究科医学専攻 / (主査)教授 平井 豊博, 教授 宮本 享, 教授 福田 和彦 / 学位規則第4条第1項該当 / Doctor of Medical Science / Kyoto University / DFAM

Obturation par système de ligature thermo-fusion de l'artère pulmonaire dans les lobectomies par vidéothoracoscopie. Objectifs : La résection pulmonaire anatomique est la stratégie de traitement principale pour les cancers du poumon non à petites cellules (CPNPC) de stade I et II. L’approche minimalement invasive est recommandée par rapport à l’approche ouverte par thoracotomie. La division de l'artère pulmonaire est généralement effectuée à l'aide d'agrafes mécaniques. Cependant, leur taille, leur rigidité et leur forme peuvent les rendre difficiles à utiliser sur les petites branches de l’artère pulmonaire, ce qui peut augmenter le risque d'hémorragie. Les appareils de ligature thermo-fusion peuvent constituer une alternative pour sceller les branches de l’artère pulmonaire avec l'avantage d'être plus petits et plus fins. Cette thèse vise à évaluer l'efficacité et la sécurité d'un appareil à énergie ultrasonique pour sceller les branches de l’artère pulmonaire de 7 mm ou moins durant les résections pulmonaires anatomiques minimalement invasives. Méthodes : Une approche par étape a été adoptée. Initialement, une étude de survie animale a été menée. L’appareil à énergie ultrasonique a été utilisé pour diviser toutes les branches de l’artère pulmonaire lors de lobectomies par thoracoscopie. Deux essais cliniques de phase 1 ont été menés ; le premier lors de lobectomies ouvertes et le second lors de lobectomies par thoracoscopie. Dans les deux essais, l’appareil à énergie ultrasonique a été utilisé pour sceller les branches de l’artère pulmonaire de 7 mm ou moins. Un essai clinique multicentrique de phase 2 a enrôlé des patients devant recevoir une lobectomie par thoracoscopie. De manière similaire aux essais de phase 1, l’appareil à énergie ultrasonique a été utilisé pour sceller les branches de l’artère pulmonaire de 7 mm ou moins. Enfin, une étude animale évaluant la production de chaleur lors du scellement de l’artère pulmonaire avec des dispositifs à énergie a été réalisée. Résultats : Dans l'étude de survie animale, 21 branches de l’artère pulmonaire ont été scellées avec l’appareil à énergie ultrasonique. Une branche de 10 mm n’était pas complètement scellée immédiatement après l’application de l’appareil à énergie ultrasonique et a correctement été scellée en réappliquant l’appareil. Il n'y a eu aucune autre complication. Dans les essais cliniques de phase 1 et 2, un total de 180 patients ont été recrutés et 239 branches de l’artère pulmonaire ont été scellées avec l’appareil à énergie ultrasonique. Trois artères n’étaient pas complètement scellées en intraopératoire et un patient a nécessité une conversion en thoracotomie. Il n'y a eu aucune mortalité postopératoire. L'étude animale évaluant la production de chaleur émise par les appareils de ligature thermo-fusion a établi que l’appareil devrait avoir une marge de sécurité de 3 mm par rapport aux structures vitales. Conclusion : Dans cette approche par étapes, l’appareil à énergie ultrasonique était sécuritaire et efficace pour sceller les branches de l'artère pulmonaire de 7 mm ou moins. L’appareil est une alternative appropriée aux agrafes mécaniques pour sceller les petites branches de l'artère pulmonaire lors de résections pulmonaires anatomiques minimalement invasives. Cela pourrait rendre les résections pulmonaires minimalement invasives plus faciles et plus sécuritaires. / Ultrasonic Energy for Pulmonary Artery Branch Ligation During VATS Lobectomy Objectives : Anatomic lung resection is the primary treatment strategy for stage I and II non-small cell lung cancer (NSCLC). A minimally invasive approach is recommended over open thoracotomy. Pulmonary artery (PA) division is usually achieved with endostaplers. However, their large size, rigidity and shape can make them difficult to apply on small PA branches and may increase the risk of PA injury and hemorrhage. Ultrasonic energy devices may represent a suitable alternative for PA sealing with the advantage of being smaller and finer. This thesis aims at evaluating the safety and efficacy of an ultrasonic energy device to seal PA branches of 7 mm or less during minimally invasive anatomical lung resections. Methods : A stepwise approach was adopted. Initially, an animal survival study was conducted. The ultrasonic energy device was used to divide all the PA branches during video-assisted thoracoscopic surgery (VATS) lobectomy in the animals. Two phase 1 trials were conducted; the first was in open lobectomy and the second in VATS lobectomy. In both trials, the ultrasonic energy device was used to seal PA branches of 7 mm or less. A multicenter phase 2 clinical trial enrolled patients undergoing VATS lobectomy. Similarly to the phase 1 trials, the ultrasonic energy device was used to seal PA branches of 7 mm or less. Finally, an animal study evaluating heat production during PA sealing with energy devices was completed. Results : In the animal survival study, a total of 21 PA branches were sealed with the ultrasonic energy device. One 10 mm PA branch had a partial seal failure immediately at the time of sealing and was successfully sealed by reapplying the device. There were no other complications. In the phase 1 and 2 trials, a total of 180 patients were recruited and 239 PA branches were sealed with the ultrasonic energy device. Three intraoperative seal failures occurred, and one patient required conversion to thoracotomy. There was no postoperative mortality. The animal study evaluating heat production established that the device tip should have a safety margin of 3 mm from vital structures. Conclusions : In this bench-to-bedside approach, the ultrasonic energy device for sealing PA branches of 7 mm or less was safe and efficient. The device is a suitable alternative to endostaplers for sealing small PA branches during minimally invasive anatomical lung resections. This has the potential to make minimally invasive lung resections easier and safer.