Successful Transplantation of Lungs From an Uncontrolled Donor After Circulatory Death Preserved In Situ by Alveolar Recruitment Maneuvers and Assessed by Ex Vivo Lung Perfusion.

We developed a protocol to procure lungs from uncontrolled donors after circulatory determination of death (NCT02061462). Subjects with cardiovascular collapse, treated on scene by a resuscitation team and transferred to the emergency room, are considered potential donors once declared dead. Exclusion criteria include unwitnessed collapse, no-flow period of >15 min and low flow >60 min. After death, lung preservation with recruitment maneuvers, continuous positive airway pressure, and protective mechanical ventilation is applied to the donor. After procurement, ex vivo lung perfusion (EVLP) is performed. From November 2014, 10 subjects were considered potential donors; one of these underwent the full process of procurement, EVLP, and transplantation. The donor was a 46-year-old male who died because of thoracic aortic dissection. Lungs were procured 4 h and 48 min after death, and deemed suitable for transplantation after EVLP. Lungs were then offered to a rapidly deteriorating recipient with cystic fibrosis (lung allocation score [LAS] 46) who consented to the transplant in this experimental setting. Six months after transplantation, the recipient is in good condition (forced expiratory volume in 1 s 85%) with no signs of rejection. This protocol allowed procurement of lungs from an uncontrolled donor after circulatory determination of death following an extended period of warm ischemia.

Rescue therapy with polymyxin B hemoperfusion in high-dose vasopressor therapy refractory septic shock.

BACKGROUND: Refractory septic shock (RSS) requiring major vasopressor support is associated with high mortality, especially in Gram-negative infections. The study aim was to describe hemodynamics, organ failure, and clinical outcomes in high-dose vasopressor therapy (HDVT) RSS patients treated with Polymyxin B hemoperfusion (PMX-HP) as rescue therapy. METHODS: We retrospectively analyzed 52 patients, unresponsive to conventional therapy, treated with two sessions of PMX-HP requiring HDVT (norepinephrine and/or epinephrine requirement (NEP+EP) ≥ 0.5 µg/kg/min), ≥ 2 organ failures, and suspected/confirmed Gram-negative infection from any source. RESULTS: At baseline, mean arterial pressure (MAP) was 80 ± 13 mmHg and NEP + EP requirement was 1.11 ± 0.56 µg/kg/min. After two PMX-HP sessions, at 72 h, MAP significantly increased and NEP + EP requirement decreased respectively by 12% and 76%. Pulmonary and renal function also improved significantly. Thirty patients (58%) showed a ≥ 50% reduction in NEP + EP dose within only 24 h after the first PMX-HP session (early responders), and 22 did not or died from irreversible shock in the same time frame (early non-responders). The 30-day hospital mortality was 29%; it was 16% in early responders and 45% in early non-responders. On multivariate analysis, SAPS II score, vasopressin, and central venous pressure significantly affected 30-day hospital mortality. CONCLUSION: This is the first study describing the use of PMX-HP as a rescue therapy in RSS patients with HDVT and MOF. Our results suggest a possible role for PMX-HP in improving hemodynamics, organ function, and mortality in RSS, with a 30-day survival of up to 70%.

Use of the Oto lung donor score to analyze the 2010 donor pool of the Nord Italia Transplant program.

INTRODUCTION: The feasibility and utility of a lung donor score that has been recently proposed was tested among a pool of lung donors referred to the Nord Italia Transplant program (NITp) organ procurement organization. MATERIAL AND METHODS: Each lung donor was assigned an Oto score including, age, smoking history, chest X-ray, secretions and ratio of arterial oxygen tension to inspired oxygen fraction (PaO(2)/FiO(2)). Based on clinical compromise, each variable received a score between 0 and 3, except for PaO(2)/FiO(2), which was scored between 0 and 6 given its overall relevance. RESULTS: Throughout 2010, 201 multiorgan donors were initially considered to be potential lung donors. Among these, 59 (29.4%) eventually yielded 67 lung transplantations (named "Used group"). Among the 142 (70.6%) refused lungs, 28 were not used due to logistic or medical problems ("general exclusion" group, GE) and 114, because of poor lung function ("lung exclusion" group, LE). Median lung donor scores were 1 (range, 0 to 3), 4 (range, 2.5 to 6.5), and 7 (range, 5 to 9) in the Used, GE, and LE groups, respectively (one-way analysis of variance, P < .001). Some donors with Oto scores ≤7 worsened over time so that the score had significantly increased by the time of organ retrieval. Overall, subjects who died after lung transplantation were characterized by higher lung donor scores, (2 [1-4] versus 0.5 [0-3], P = .003). CONCLUSION: Our analysis suggested that the use of a donor score as a dynamic tool over the donation process was of great utility to describe and analyze a pool of lung donors.

Lung procurement for transplantation: new criteria for lung donor selection.

In Italy, like everywhere in the world, the organ shortage for transplantation is a real problem. It is well known that lung donors (LD) are particularly difficult to procure and that management of the organ do not care during the diagnosis of cerebral death represents a difficult challenge. In this context, the salvage of the so-called "marginal donors" may increase the pool of donors, favoring organ retrieval. To increase lung procurement, the intensivist must recognize "marginal donors," optimizing organ selection and function. The aim of our study was to review LD procured in 2008, as identified by the unrestricted criteria, of the Nord Italian Transplant program Center (NITp). Particularly, the age and habits of donors and the presence of a parenchyma contusion were not sufficient per se to exclude donation. We revisited lung ventilation and monitoring modalities during cerebral death before retrieval. In 2008, the application of enlarged criteria for LD enabled us to collect 21 LD, namely 33% of all cerebral deaths, versus 13% in 2007. Seeking to maintain good gas exchange and lung function, we implemented a safe ventilation program avoided high peak pressures, and fluid therapy properly guided by the cardiac index and extravascular lung water index monitoring. Specific actions to improve LD procurement may help cope with the organ-donor shortage. Although our series was small, our results were encouraging; they underline the necessity to continuously review donor criteria and care, allowing good donor/recipient matching.

Quality and quantity of volume replacement in trauma patients.

An epidemiologic evaluation of trauma-related deaths in trauma centers reveals that the majority of patients die within 6 hours from exsanguination, whereas secondary brain injuries predominate between 6 and 24 hours. Late deaths remain attributable to sepsis and pulmonary embolism,1-3 while early deaths are due in part to multiple bleeding injuries or to a set of complex and untreatable injuries, mainly of the liver and pelvis. Before trauma systems existed, these patients died at the scene of the trauma, whereas since the establishment of the trauma system, they die in emergency or operating rooms. Another subset of early deaths result from severe bleeding injuries, which could be prevented if recognized early. For instance, if a 70 kg adult had a blood volume of 70 mL/kg (5 L), hypotension (systolic blood pressure [SBP]<90 mmHg) would usually occur after a one third-loss of blood volume, and death would follow with a 50% loss. A patient bleeding at a rate of 25 mL/min will become hypotensive within one hour and die within two hours, while a patient bleeding at a rate of 100 mL/min will be hypotensive within 15 minutes and die within 30 minutes. These considerations indicate a narrow window of opportunity for targeting fluid resuscitation. Moreover, increases in blood pressure before surgical hemostasis have been shown to disrupt clotting and increase bleeding, a fact that has been confirmed by a number of animal and human studies on uncontrolled hemorrhage. Furthermore, oxygen must be delivered to vital organs (brain, heart) to prevent death during hemorrhage. In summary, several constraints account for the differences in fluid use, timing of infusions, and determinations of whether to administer fluids at all.

Niguarda Trauma Team: outcome of three years of activity.

BACKGROUND: The aim of this study was to prove the existence of a direct relationship between the comprehensive strategy of trauma management and an enhancement in outcome. Tests were carried out on the impact of the Niguarda Trauma Team System on mortality rates due to severe trauma. METHODS: The epidemiological data was retrospectively reviewed along with, the severity scores: Abbreviated Injury Scale (AIS), Injury Severity Score (ISS), Revised Trauma Score (RTS), Probability of survival (Ps) and the outcome of severe trauma admitted to Niguarda hospital between October 2002 and September 2005. All data were collected from the Trauma Registry of the Niguarda Hospital. Two subsequent periods of 20 and 16 months were compared. RESULTS: Nine hundred forty-two severe traumas (94.05% blunt trauma) were recorded with an overtriage rate of 36.09%. Most patients were admitted for bone and muscular injuries (52.22%). Excluding the patients who were overtriaged, there were 129 patients who died. Comparing the two periods, the Authors observed a significant reduction in mortality from 22.56% to 19.75%, mainly related to a decrease in early mortality due to hemodynamic instability. Central nervous system injury was the main cause of death (65%). Average hospital stay significantly decreased from 17.01+/-12.07 days to 14.97+/-10.34 days. CONCLUSION: Introducing a comprehensive strategy of severe trauma management, the Niguarda Trauma Team System had a significant impact on mortality rates and hospital stay.

Treatment of critical bleeding in trauma patients.

AIM: Massive haemorrhage after trauma is a big challenge for care-givers, being a leading cause of early in-hospital mortality. Surgical bleeding may be easily controlled with several techniques. Otherwise, consumptive coagulopathy is often extremely difficult to stop. An adjunctive strategy to treat traumatic coagulopathic bleeding is recombinant activated factor VII (rFVIIa) (NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark). METHODS: All major trauma victims haemodinamically unstable (systolic blood pressure < 90 mmHg or > 90 mmHg with massive infusions or vasopressors) admitted to the Emergency Department of the Niguarda Ca' Granda Hospital in Milan from October 2002 to September 2005 were reviewed. Mechanical bleeding was controlled with interventional techniques when indicated. Blood derivatives were administrated to maintain haemoglobin> 7 g/dL, INR < 1.5, fibrinogen > 1 and platelet count > 50 x 109. Off-label administration of rFVIIa was performed in the last year in any coagulopathic salvageable patient when all other strategies failed to control bleeding. RESULTS: Major trauma were 942, mean age 32.49+/-18.44 years, 94% blunt trauma, 25.13% haemodynamically unstable. Deaths occurred in 17.02% of cases before any procedure. Emergency invasive treatments were performed in 72.34% of cases. Infusions restored haemodynamic stability in 10.63% of patients. In average 9.4+/-4.1 units of red blood cells were transfused in unstable patients. rFVIIa (dosing 60-100 mg/kg) was administrated in 12 patients. Mortality occurred in 33.33% of cases. The principal cause of death was brain injury. A femoral artery thrombosis was observed in a mangled leg. No other adverse effects due to rFVIIa were documented. CONCLUSIONS: Off-label administration of rFVIIa was able to reverse life-threatening bleeding not manageable with standard strategies in our series of major trauma patients without systemic adverse effects.

[Trauma registry at the Niguarda Ca' Granda Hospital of Milano: epidemiology and quality assessment]. / Il Registro Traumi dell'Ospedale Niguarda Ca' Granda di Milano: dati epidemiologici e verifica di qualità.

OBJECTIVE: In a Trauma System, Trauma Registry allows the assessment of epidemiology and quality of patient care. MATERIALS AND METHODS: Data about trauma patients admitted to Ospedale Niguarda Emergency Department from October 1, 2002 to June 30, 2003 with ICD9CM code 800-939.9 and 950-959.9 were prospectively recorded. Injury severity score (ISS) and revised trauma score (RTS) were calculated and probability of survival (Ps) was derived. RESULTS: During the study period 1811 trauma patients were admitted, and 271 (14.96%) were consistent with triage criteria of severity. Among these, survivors were 220 (81.18%) and blunt trauma 95.94%. Injuries of the central nervous system with (11.76%) or without (50.98%) hemodynamic instability or hemodynamic instability alone (31.37%), were the principal causes of death. An ISS greater than 15 was observed in 61.25% with an overtriage of 38.75%. Seventy seven patients accepted without triage criteria of severity died or were admitted to intensive care unit with an undertriage of 5%. Ps among victims was 22.35 +/- 27.19 and possible preventable deaths were 6 (11.76%). No frankly preventable death was recorded. DISCUSSION: Standard pre-hospital triage criteria are associated with significant over and undertriage. Data collection using large population-based data base increases epidemiologic value of trauma registry. Analysis of Ps identifies cases who need clinical discussion to assess adequacy of treatment. CONCLUSIONS: Prospective data collection in a trauma registry may provide all informations useful to improve quality of trauma patient care.

[Cornea donation: role of the local coordinator in monitoring and implementation]. / Attività di prelievo di cornea. Ruolo del coordinatore locale nel monitoraggio e nell'implementazione.

BACKGROUND: In order to contribute to the dissemination of an organ and tissue donation culture, the authors report the results of a retrospective investigation into the donation of corneas for transplantation relative to the period from January 1997 to December 2001 at a leading hospital in the Milan area. METHODS: All cases of intra-hospital death (n=2137) were considered. The adoption of a selection protocol for potential donors, in accordance with the indications of the North Italy Transplant program, and constant monitoring on the part of the local coordinator, led to the collection of 348 corneal flaps using the procedure whereby all deaths have to be notified to the Health Department. RESULTS: Over this period, the donors/deaths ratio increased from 2.1 to 17.6%, while the collection index (real donors/potential donors including those wrongly excluded) increased from 40.8% in 1999-2000 to 67.8% in 2001. Most involved in the donor selection activity were the intensive care centres with an increase for Resuscitation of 12.7% and for First Aid of 33%, to a lesser extent non-intensive centres (increase of 11.2%). The causes of exclusion from cornea collection in the last three-year period were clinical contraindications in 51.2% of cases (sepsis, blood transfusions, diseases of the central nervous system of unknown aetiology), failure to activate the procedures in 17.4% of cases, opposition in 17%, unsuitability of the corneal tissues in 11.3%, inadequate age in 3%. CONCLUSIONS: The results obtained indicate good prospects for technical implementation and for the development of a donation culture in respect of other organs and tissues.

[Protocol for preoperative chest X-rays in elective surgery]. / Protocollo per l'esecuzione della radiografia preoperatoria del torace nella chirurgia d'elezione.

BACKGROUND: To evaluate the effects of a protocol designed to optimize the use of preoperative chest X-rays (CXRs) in the evaluation of patients undergoing anesthesia for elective surgery. DESIGN: Observational prospective study. SETTING: General 350 bedded hospital, with main surgical branches. METHODS: a) PROTOCOL: routine CXRs can be avoided in patients aged less than 60 years, nonsmokers, without acute-chronic respiratory, cardiovascular symptoms, free from neoplastic diseases, not candidates to major vascular, abdominal or thoracic surgery, not treated with immunosuppressive therapy, nor immigrants from areas of endemic TB. b) All out patient subjects admitted to anesthesiology service for evaluation prior to elective surgery. RESULTS: Out of 5198 patients, 3795 were enrolled in the protocol; in 152 cases, preoperative CXRs were performed, 3456 patients (57.2% ASA 1; 42% ASA 2; 0.8% ASA 3) underwent surgery without CXRs. Thirty-four percent of patients had general anesthesia, 54.5% regional anesthesia, 20.6% regional-peripheral anesthesia with/without MAC. No critical events nor major complications were observed in the perioperative period in these subjects. Preoperative CXRs (performed in 152 cases) yelded useful informations with effect on the clinical management in 20 instances. CONCLUSIONS: In a context of adequate preoperative anesthesiologic evaluation, this protocol proved to be effective in reducing the number of routine preoperative CXRs in patients undergoing elective surgery. This resulted in a substantial reduction of radiation exposure both to the subject and to the general population, and costs saving, without evident negative side-effects.

[Anesthesia in Apert syndrome]. / Anestesia nella sindrome di Apert.

The anaesthetic technique chosen for a laparohysterectomy in a woman affected by Apert's acrocephalosyndactilia is described. Difficulties in performing tracheal intubation were overcome by mean of loco-regional anesthesia (LRA). In order to minimize the anaesthetic risk, a standardised preoperative evaluation and assessment integrating the usual investigations and the possibility of employing intubation techniques as alternative to direct laryngoscopy are suggested.

[Daily survey of procedures as markers of resources utilization]. / Rilevazione giornaliera di procedure come tracciante dell'utilizzo di risorse.

OBJECTIVE: To assess and to follow along the time-span of ICU stay the process of resources allocation and utilization. DESIGN: Prospective study. PATIENTS: A cohort of 778 patients consecutively admitted to 7 multipurpose general ICU in the Milano area were enrolled in a survey of the daily performed interventions/procedures. MEASUREMENTS AND MAIN RESULTS: The majority of diagnostic procedure/interventions were performed during the first two days. The number and quality of interventions were transferred into points obtaining a score system in non-monetary units. The resource allocation process shows a regular trend in the sub-intensive patients who were only monitorized. On the contrary the 258 patients who were intensively treated and survived show a phase of high resource-consumption (about 30 daily points: roughly twice the score of monitorized patients) then followed by a post-intensive phase with a resource consumption resulting in a daily score absolutely equal to the sub-intensive patients. The intensive patients who die show a significantly higher score than survived patients. Both daily and cumulative scores do not show differences among different type of patients. CONCLUSION: The evaluation of the process of resources allocation, even if in non-monetary units enables the knowledge of the trend of ICU costs and allows the elaboration of the appropriate budget mechanism.

["ARCHIDIA": a system for patients' data collection and computerized filing. Part I. Methodology]. / Sistema di raccolta dati paziente e archiviazione computerizzata "ARCHIDIA". Parte I--Metodologia.

This report describes a computer based program of patient clinical data collection: the ARCHIDIA system. The project relies on descriptive analysis of clinical events according to well defined methodological criteria. This allows the formulation of a concise diagnosis which is, at the same time, exhaustive of all essential information. Two are the basis principles of this methodology: To define, as accurately as possible, the logical steps necessary to elaborate the diagnosis, that is construed by a sequence of codes. To define all the conditions that must be followed so to use any code in a controlled and independent way. These criteria were derived from literature. The major claim of the system is likely to be the introduction of a "common language" between different ICUs. Uniformed diagnostic and clinical criteria are the main source of large data collection for descriptive, analytic and prospective studies. After a one year pilot study performed by 4 ICUs, ARCHIDIA was used, in 1991, by 20 centers from the area of Milan, Pavia, Como, Varese (70% of total) and 4148 patient data were collected. A descriptive analysis will be reported in the following paper.

["ARCHIDIA": a system for patients' data collection and computerized filing. Part II. General description of a caseload]. / Sistema di raccolta dati paziente e archiviazione computerizzata "ARCHIDIA". Parte II--Descrizione generale della casistica.

OBJECTIVE: To describe a population of patients admitted in ICU in an homogeneous urban area by means of a computed system. EXPERIMENTAL DESIGN: Observational study. SETTING: 20 general intensive care units of general and university hospitals. PATIENTS: Patients admitted in ICU from 1-1-1991 to 31-12-1991. 3 centers collected patients only for 6 months, starting on 1-6-1991. MEASUREMENTS: For each patient demographic data, hospitalization data, outcome, diagnosis and diagnostic procedures used during hospitalization according to defined criteria previously described, were collected. Data have been collected on PC using dedicated software. RESULTS: All centers concluded data collection, none abandoned the study. General characteristics of 4148 valuable patients were reported. Age was 52.9 years, SAPS 12.4 and mortality 21.7%. The patients spent 8.7 days in ICU and, when transferred to a general ward, the following hospitalization was 21.5 days. CONCLUSIONS: Data collection demonstrated the project feasibility. It realizes a continue up to date system inside each unit and allows the use of a "common language" and homogeneous methodology between centers.