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Insurance statements from French anaesthesiologists and intensivists: A database analysis
Accepted Manuscript Title: Insurance statements from French Anaesthesiologists and Intensivists: a database analysis Author: Boutonnet Mathieu Trouiller Pierre Lopard Eric Amalberti Ren´e Houselstein Thierry Pasquier Pierre Auroy Yves De Saint Maurice Guillaume PII: DOI: Reference:
S2352-5568(16)30074-1 http://dx.doi.org/doi:10.1016/j.accpm.2015.11.010 ACCPM 164
To appear in: Received date: Revised date: Accepted date:
7-4-2015 15-6-2015 27-11-2015
Please cite this article as: Boutonnet MathieuTrouiller PierreLopard EricAmalberti Ren´eHouselstein ThierryPasquier PierreAuroy YvesDe Saint Maurice Guillaume Insurance statements from French Anaesthesiologists and Intensivists: a database analysis (2016), http://dx.doi.org/10.1016/j.accpm.2015.11.010 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
*Title page
Title Insurance statements from French Anesthesiologists and Intensivists: a database analysis.
Author names
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Pasquier Pierred, Auroy Yvese, De Saint Maurice Guillaumef.
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Affiliations a
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Boutonnet Mathieua, Trouiller Pierreb, Lopard Ericc, Amalberti Renéc, Houselstein Thierryc,
Department of Anesthesiology and Intensive Care Unit, Percy Military Teaching Hospital,
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101 avenue Henri Barbusse, Clamart, France. e-mail address: [email protected]
Intensive Care Unit, Antoine Béclère University Hospital, 157 Rue de la Porte de Trivaux,
Clamart, France.
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b
MACSF – Le Sou Médical, 10 cours du Triangle de l’Arche, 92919 La Défense Cedex
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Intensive care unit, Begin Military Teaching Hospital, 69 avenue de Paris, Saint-Mandé,
France e
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c
Hospital and Research Division, Head Office of Military Health Service – Direction centrale
du service de santé, Fort-Neuf de Vincennes, Cours des Maréchaux, Vincennes, France. f
Department of Anesthesiology and Intensive Care Unit, Val-de-Grâce Military Teaching
Hospital, 74 boulevard de Port Royal, Paris, France.
Corresponding author Boutonnet Mathieu Department of Anesthesiology and Intensive Care Unit, Hôpital d'Instruction des Armées Percy (Military Teaching Hospital), Clamart, France.
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Address: 101 avenue Henri Barbusse, 92140 Clamart, France Phone number: +331 41 46 62 21 Fax number: +331 41 46 64 47
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e-mail address: [email protected]
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Insurance statements from French Anaesthesiologists and Intensivists: a database analysis
Department of Anaesthesiology and Intensive Care Unit, Percy Military Teaching Hospital,
101 avenue Henri Barbusse, Clamart, France.
b
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e-mail address: [email protected]
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a
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Pasquier Pierred, Auroy Yvese, De Saint Maurice Guillaumef.
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Boutonnet Mathieua, Trouiller Pierreb, Lopard Ericc, Amalberti Renéc, Houselstein Thierryc,
Intensive Care Unit, Antoine Béclère University Hospital, 157 Rue de la Porte de Trivaux,
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Clamart, France.
MACSF – Le Sou Médical, 10 cours du Triangle de l’Arche, 92919 La Défense Cedex
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Intensive care unit, Begin Military Teaching Hospital, 69 avenue de Paris, Saint-Mandé,
d
c
e
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France
Hospital and Research Division, Head Office of Military Health Service – Direction centrale
f
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du service de santé, Fort-Neuf de Vincennes, Cours des Maréchaux, Vincennes, France. Department of Anaesthesiology and Intensive Care Unit, Val-de-Grâce Military Teaching
Hospital, 74 boulevard de Port Royal, Paris, France.
Corresponding author Boutonnet Mathieu
Department of Anaesthesiology and Intensive Care Unit, Hôpital d'Instruction des Armées Percy (Military Teaching Hospital), Clamart, France. Address: 101 avenue Henri Barbusse, 92140 Clamart, France Phone number: +331 41 46 62 21
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Fax number: +331 41 46 64 47 e-mail address: [email protected]
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Introduction
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Since their beginnings, anaesthesia and intensive care have faced substantial risks and the associated management challenges [1]. No one can ignore today that our discipline stands at
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the crossroads of fields as varied as medicine, epidemiology, risk analysis and control, insurance, and justice. Considerable progress has been made regarding anaesthetic risk
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control through technical adaptations (monitoring), the improvement of medical knowledge in
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legislation such as the 1994 decree in France which established pre-anaesthetic consultations and post-anaesthesia care units (PACU), organizational changes including guidelines
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emerging from medical associations and checklists, and cultural changes like the reporting
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and analysis of serious adverse events [2]. However, perioperative adverse events remain frequent, occurring in approximately 30% of hospital admissions, and may be avoided in
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more than 50% of cases [3]. Thus, the efforts to improve our practices should be continued. Risk control cannot be understood without measurement and analysis. However, in France, to the best of our knowledge, there is no national registry for the analysis of liability related to anaesthesia [4]. The aim of this study was to assess if an assurance database could enable the measurement and analysis of the medical risks implicated in anaesthesia and intensive care practices. We performed an assessment of the database of a medical insurance company from a medical viewpoint rather than an insurance one. An agreement was created between the French society of anaesthesiology and intensive care (SFAR) and the MACSF-Sou Medical insurance company to access and analyse the insurance database.
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1. Materials and methods 1.1.
Overview of perioperative practices and their
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insurance coverage There were 10,949 anaesthesiologists and intensive care practitioners in France in January
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2014 [5], and of these 4,387 had a private practice (40.1%). The MACSF-Sou Medical
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insurance company covered 43.6% of the anaesthesiologists and intensive care practitioners in France, regardless of their practice status. The MACSF-Sou Medical insurance company
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covered 1,160 practitioners (26.4%) with a private practice and 3,570 (54.4%) with a public practice. The company was the leading insurance group insuring the public practice of
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anaesthesia and intensive care and the second one for private activities. In the same timeframe, there were 25,802 surgeons in France, including all specialties. Of
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these, 18,015 (69.8%) had a private practice [5]. In 2014, the MACSF-Sou Medical group
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was the third largest insurance company regarding the coverage of surgical practice. It
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covered 4,270 (16.5%) surgeons in 2014, notably 2,510 (13.9%) with a private practice.
1.2.
Data
Our study is a retrospective analysis of all the statements involving an anaesthesiologist covered by the MACSF-Sou Medical insurance company in metropolitan France between 1986 and 2011. The selection of the appropriate statements was performed as follows: declaration by an anaesthesiologist or an intensive care practitioner to the insurance company of an adverse event (either with medical and legal implications, or not), reclamations or claims addressed to the insurance company by another insurance group, reclamations or claims directly addressed to the insurance company by a patient, reclamations or claims addressed by a patient through the Regional Commissions for Conciliation and Reparation for
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Medical Accidents, and claims addressed to the insurance company by the judiciary entities (penal or civil legislation). The MACSF-Sou Medical insurance company collected the declarations through a
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standardized form. An expert senior anaesthesiologist, employed by the insurance company, read this form and summarized the event in a short report, including circumstances. All of
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these adverse event reports were collected in an Excel® database. These data were
1.3.
Assessment agreement
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anonymous as concerns physician and patient names.
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An analytical agreement was concluded between the Sfar and the MACSF-Sou Medical
perform a scientific analysis.
Analysis method
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1.4.
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insurance company. This agreement stated that the Sfar had access to the database in order to
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A group of three expert members of the Sfar, senior anaesthesiologists, have analysed the
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reports in order to perform analysis. Two different experts have read each report. Each expert was asked different questions in a three-step analysis. The first step of the analysis was to describe the circumstances of the event. The second step was to assess the adverse event regarding the type of complication, such as cardiac arrest, severe systemic complication without death, other complications and conflicts. The analysis was performed for each type of event according to a method which assigned a code to each clinical pathway. The encoding method is described below. Finally, in the third step the expert had to evaluate the consequences of the adverse event for the patient, its possible relation to anaesthesia and the occurrence of an error as the initial cause, when possible.
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1.5.
Exclusion
Dental traumas and the cases directly related to a regional anaesthesia technique were
1.6.
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excluded.
Collected items
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The data collected mixed factual (clinical and demographic characteristics) and interpretative
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items (results of the expert evaluations). The variables collected are presented in Table 1, classified by origin. The circumstances of the events included the term "observation" which
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was not the time of occurrence of the event but rather the moment when the practitioner was aware of the symptoms reported by patients or observed by the health care team.
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The second step of the analysis was to code each statement according to the mechanism that led to the event. Each type of event (cardiac arrest, severe systemic complication without
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death, other complications and conflicts) could be encoded in a dedicated mechanistic tree
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that allowed encoding for each clinical pathway. The code was designed to describe as
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accurately as possible the trajectory, consequences and circumstances of the event reported in the story. Following this principle, a six-figure code can describe the pathophysiological pathway leading to a serious complication of a significant function. Thus, a laryngeal obstruction of the upper airway responsible for death from respiratory causes would be coded 122210 (1 for death, 2 for Respiratory, 2 for Airway, 2 for Obstruction, 1 for xxx, 0 for not enough information on the precise location of obstruction). It would be 122100 if it was following a difficult intubation, or 211150 if a cement embolism was responsible for a cardiogenic shock not leading to death. The complete list of codes is presented in Annex 1. At the end of the coding process, concordance between the two experts was verified. In case of discordance, the three experts collegially coded the litigious cases.
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1.7.
Statistics
Statistical analysis was performed using Microsoft ® Excel ® Version 14.3.2. Data are
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expressed as numbers (%) or means (SD).
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2. Results
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A total of 870 statements were analysed after exclusion of 592 dental injuries and 164 statements related to regional anaesthesia. The events took place between 1986 and 2011.
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Circumstances of the events
The patients involved were predominantly women (sex-ratio 0.86), with a mean age of 56
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years (± 18). ASA status was poorly documented (175/870), as were treatments (158/870) and past medical history (470/870). The characteristics of the population involved in the
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declarations are summarized in Table 2.
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The most frequently reported specialties in the declarations were orthopaedic surgery and visceral surgery. However, this does not reflect a rate of sinistrality as we did not have access
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to the total number of procedures performed in each specialty by the practitioners. Table 3 presents the distribution of the declarations per specialty. The context of emergency was found in 90.5% (787/870) of cases. An emergency context was present in 159 cases (18.3%). Table 4 presents the number of events per year. The anaesthetic technique was known in 658 cases (75.6%), and was GA in 506 cases (58.2%), GA associated with RA in 54 cases (6.2%) and RA alone in 98 cases (11.3%). Most of the events were observed in the postoperative period (79.3%). It is important to note that nearly half of the events were declared after discharge from the post-anaesthetic care unit and remarkably 15% after hospital discharge. Table 5 summarizes the time of observation of the declared events.
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Description of the events The total number of events reported by the practitioners that finally led to a cardiac arrest was 315 (36.2%). The cause was absolutely undefined in 25 of these cases. A cardiovascular
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origin was identified in the majority of the cases (216/315), representing nearly two-thirds of the total number of the events leading to a cardiac arrest. A relative or true hypovolaemia was
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at the root of the complication in 158 of these cases. A respiratory problem was the second type of complication leading to a cardiac arrest, but it was far behind cardiac events (44/315
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cardiac arrests), and neurological events accounted for 20 of the 315 cases. Figure 1 presents
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a tree diagram for the events that led to a cardiac arrest. The importance of each trajectory in terms of number of cases is represented by the thickness of the respective branch.
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The total number of severe systemic complications reported by the practitioners was 157 (18%). Cardiovascular events also represented a major pattern (70/157), but neurological
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events were almost as frequent (64/157). Respiratory problems were much more rare
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(18/157). A true or relative hypovolaemia was present in the vast majority of the severe cardiac complications, as in the cases of cardiac arrests. True or relative hypovolaemia
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appeared as a major perioperative concern. However, stroke was also a great concern and accounted for 75% of the neurological complications. Figure 2 is the tree diagram for the events that corresponded to a severe systemic complication. The others events declared by anaesthetists or intensivists that were not classified as severe accounted for 340 cases (39.1%). Almost one-third of these were surgical site infections (105/340), and the second major pattern represented was a peripheral neurological lesion (65/340), mostly related to malposition during surgery. Concerning surgical site infections, the experts could only evaluate the antibiotic management (therapeutic or prophylactic) in 39 of the 105 cases. The antibiotic management was considered inadequate in 15 of these cases. Figure 3 is the tree diagram for the other events.
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One hundred and six events (12.2%) were analysed as a conflict between the practitioner and the patient. The total number of events exceeded 870 because some of them were analysed twice in case of associations, such as a conflict associated with a surgical site infection. Most
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of the conflicts (35/106) involved a missed or delayed diagnosis. Consequences of the events
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The consequences were analysed according to the French nomenclature of corporal damage (permanent functional deficit, PFD). A total of 312 patients died (35.9%), including 13
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newborns. Thirty patients (3.4%) had no consequences and 131 (15.1%) recovered without
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sequelae. Table 6 presents the functional consequences of the declared events. The evaluation of the need for additional care was difficult, but this data was present for 394 patients and the
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experts were able to exclude this requirement for 12 patients.
The experts were able to assess links with anaesthesia in 815 cases (93.7%). This relationship
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was deemed excluded or doubtful in nearly two-thirds of cases (61%). Figure 4 represents the
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relationship between the reported events and anaesthesia. The notion of an error at the root of the event was evaluable in 594 cases (68.3%). The error
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was deemed probable or certain in a little over a quarter of the cases (27.5%). The type of error could be specified in 200 cases (23%), and routine errors were the most frequent (100/200). Figure 5 represents the evaluation of the notion of errors at the root of the event.
3. Discussion
Key findings Accessing the insurance data enables an innovative approach to analysing anaesthetic risk through a medical prism. The main result we wish to highlight is the growing burden of
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delayed complications following anaesthesia. Indeed, our results highlighted the fact that anaesthesiologists have to face situations that extend into the vast perioperative area, and they particularly stressed several insufficiencies in the postoperative period. The medical
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consequences and possible legal consequences are serious, as illustrated by the high rate of mortality (nearly one-third of the patients) involved in the statements analysed. This high rate
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of mortality is of course partly explained by the exclusion of the statements for dental lesions. Dental trauma linked to anaesthesia is the first cause of sinistrality in anaesthesiology and a
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well-known concern for insurance companies [6]. However, this phenomenon is well
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described, and French preventive guidelines have been established to diminish this burden [7]. Thus, we decided to exclude these specific injuries from our analysis in order to focus on the
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most serious, though less frequent, events.
The results concerning the statements that involved cardiac arrest signal the importance of
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haemodynamic management and notably of hypovolaemia. It is important to note that we did
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not study per-operative cardiac arrests, but rather statements including a cardiac arrest independent of the time spent since surgery. The French inquiry on anaesthesia-related
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mortality had already stressed the major importance of haemodynamic management and notably perioperative haemorrhage [2]. Nevertheless we would like to point out that the methods used in our study are different for several major reasons. First, we studied raw data regardless of the link to anaesthesia. Second, we studied cardiac arrests which occurred during the entire perioperative period. This can explain why relative hypovolaemia and notably sepsis are great concerns. Third, we studied cardiac arrests, recuperated or not. The same reasons can explain the relative low rate of respiratory problems linked to upper airway management. The aim of the study was not to perform a specific analysis of difficult airway management, but our results may be consistent with a decrease in death or brain damage as a consequence of the development of guidelines and new devices for managing the
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difficult airway [8]. A relative or true hypovolaemia was the main clinical pathway that led to a cardiac arrest or a serious systemic complication. This outcome should be carefully considered and should lead to a better evaluation of the haemodynamic status during the per-
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operative and postoperative periods. The second clinical pathway to which we should pay attention is the high rate of serious
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neurological complications, notably stroke, that appeared in the second tree. Stroke is a
recognized complication in cardiac surgery [9]. For several years, stroke has also appeared to
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be a great concern in non-cardiac surgery. The Poise Trial had unintentionally stressed the
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importance of perioperative stroke and its consequences in terms of health burden [10]. One year later, Bateman et al. [11], examining the epidemiology of acute ischaemic stroke in a
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cohort of 371,641 patients undergoing non-cardiac and non-vascular surgery, demonstrated that stroke was an important cause of morbidity and mortality associated with surgery.
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Indeed, the rate of stroke ranged from 0.2% in patients undergoing total hip replacement to
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0.7% in patients undergoing hemicolectomy. The factors associated with acute ischaemic stroke were age and cardiovascular risk (atrial fibrillation, previous stroke, valvular disease
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and renal disease).
Our study pointed out that the complications following surgery and anaesthesia are often delayed and are difficult to link to the surgery or to the anaesthetic technique. In fact, the sum of the cases with a link to anaesthesia as doubtful, probable or unknown was 35.2%. It is now time to consider two objective points. First of all, patient safety will progress if the perioperative practitioners that anaesthesiologists are truly take into account the postoperative period and the delayed complications. Active postoperative policies have shown some evidence in improving acute and long-term cardiac outcome following major orthopaedic surgery, illustrating that delayed complications should not be considered as a fatality [12]. Second, it is questionable whether or not the attempts to link a delayed complication to a
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surgical or an anaesthetic act is of importance. Indeed, our results suggest that whatever this link, anaesthesiologists are directly involved in these delayed complications that sometimes occur long after the surgery, even outside the hospital. This plea for a more adequate
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perioperative management has already been made by some [13]. Our results are consistent with those of the EuSos study that focused on perioperative management after non-cardiac
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surgery in Europe. Revealing a global mortality rate of 4%, higher than expected, the authors advocated placing the notion of perioperative care at the core of care organization [14].
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This study highlights the importance of collaboration between insurance companies and
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medical societies. In the past decades, such an association has already been successfully practiced [15, 16]. Managing perioperative risk is a complex process that requires a
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multimodal approach. In the future, crisis resource management and team training are emerging concepts inherited from the aviation training system that may be of importance for
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patient safety in anaesthesia [17]. To illustrate that insurance companies are interested in
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patient safety, some insurance companies have already adopted dedicated policies for promoting educative programs in crisis resource management for insured practitioners [18].
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We expect that the future will offer many such collaboration opportunities between insurance companies and the medical world with the aim of patient safety. Analysing rare events such as anaesthesia complications is a difficult process and may require a large collection of prospective data over long periods. Different methods of analysis have been developed to overcome these difficulties. Prospective cohort studies have been conducted, despite the difficulties, on the basis of practitioner statements [19]. Another approach to such rare events is collecting and analysing patient plaints, such as performed by the "Closed Claims Project" in the US [20]. Certain countries benefit from national declarative registries that allow a specific focus on rare events related to care [21]. However, in France we do not maintain a national registry focused on liability associated with
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anaesthesia [4]. Collaborating with an insurance company is an example of a novel and successful approach for assessing risk and liability related to anaesthesia and intensive care practices. As compared with the “Closed Claims Project,” the method we propose has the
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advantage of including more events than simply the sole cases of claims. As compared with national registries, the data collection is not specifically structured for analysing specific
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events and cannot be used for performing a perfect root-cause analysis. However, this original method allowed us to perform a global assessment of risk and burden associated with
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anaesthesia and intensive care practices, and our results illustrate the efficiency of
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collaborative work between an insurance company and a medical society. Limitations
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The main limitation of our study is the fact that data collection was performed according to an insurer point of view, with a possible triple subjectivity from the declarant, the insurer and
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from the experts who analysed each story. To minimize this bias, we constructed an original
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method for data interpretation. The method was based on the a priori construction of trees describing the various possible mechanisms of occurrence of the events. Each branch of a tree
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was translated into a code whose number of digits matched the number of bifurcations of the branch. The code was designed to describe as accurately as possible the conduct, consequences and circumstances of the reported event. Nevertheless, we failed to identify certain undesirable events such as the implication of equipment problems. For instance, on the basis of the Closed Claim project, patient’s injuries from gas delivery equipment problems are declining over the last decades but remain at the root of serious harm for patients [22]. The database and the method used failed to identify this type of problem. However, we performed a secondary search by keyword and identified only one case of a gas delivery equipment problem, and that was detected and corrected preoperatively, without clinical consequences. Most of the events related to equipment involved burns from warming devices (n=2) or flame
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from the conjunction of alcohol and electric cautery (n=1). Usually, burns during anaesthesia are subsequent to the misuse of a device intended to warm the patient [23]. Our study could not confirm this point. Unfortunately, the data collected could not be used to perform a
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systemic risk analysis because of the lack of information. Such an analysis would have been highly hazardous. For the same reasons, the conclusions regarding the notion of error and
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relationship with anaesthesia should be considered cautiously. One of the most important
conclusions of this study is the growing area of delayed complications following anaesthesia
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and surgery. In addition, we showed that it is often difficult to conclude whether the
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complication is related to anaesthesia, surgery or both. However, as expressed above, patient safety will certainly increase independently of that link, perhaps due to a greater involvement
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Conclusion
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of anaesthesiologists in the postoperative period.
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Collaborations between insurance companies and medical societies are possible and offer an original point of view from which to assess perioperative risk. This study highlights the importance of delayed complications. The two burdens of particular interest are cardiovascular disease (notably hypovolaemia) and central neurological complications, (notably stroke) that are responsible for a large part of postoperative mortality and morbidity. These complications occur in the vast postoperative period, often late after surgery, sometimes outside the hospital. During this period, the link with surgery or anaesthesia is difficult to establish and probably of low interest, considering that anaesthesiologists are involved in these complications regardless of the link with the anaesthetic act itself. This study is a supplemental argument to plea for a more intense implication of anaesthesia in
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postoperative care with the aim of improving patient safety. This is one of the relevant
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challenges for our specialty.
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[1] Gaba DM. Anaesthesiology as a model for patient safety in health care. Bmj 2000; 320: 785-8. [2] Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, et al. Survey of anesthesia-related mortality in France. Anesthesiology 2006; 105: 1087-97. [3] Wacker J, Staender S. The role of the anesthesiologist in perioperative patient safety. Curr Opin Anaesthesiol 2014; 27: 649-56. [4] Trouiller P, Lopard E, Mantz J, Farman T. De la compliance médicale à l'indemnisation du préjudice. Ann Fr Anesth Reanim 2012; 31: 626-31. [5] INSEE. Médecins suivant le statut et la spécialité en 2014. http://www.insee.fr/fr/themes/tableau.asp?reg_id=0&ref_id=NATTEF06102 (accessed 11/06/2015) [6] Laidoowoo E, Baert O, Besnier E, Dureuil B. Lésions dentaires et anesthésie: épidémiologie et impact assurantiel sur quatre années au CHU de Rouen. Ann Fr Anesth Reanim 2012; 31: 23-8. [7] Nouette-Gaulain K, Lenfant F, Jacquet-Francillon D, Belbachir A, BournigaultNuquet A, Choquet O, et al.Bris dentaitres périanesthésiques : texte court. Ann Fr Anesth Reanim 2012; 31: 213-23. [8] Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology 2005; 103: 339. [9] Pawlaczyk R, Swietlik D, Lango R, Rogowski J. Off-pump coronary surgery may reduce stroke, respiratory failure, and mortality in octogenarians. Ann Thorac Surg 2012; 94: 29-37. [10] Group PS, Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet 2008; 371: 1839-47. [11] Bateman BT, Schumacher HC, Wang S, Shaefi S, Berman MF. Perioperative acute ischemic stroke in noncardiac and nonvascular surgery: incidence, risk factors, and outcomes. Anesthesiology 2009; 110: 231-8. [12] Ausset S, Auroy Y, Verret C, Benhamou D, Vest P, Cirodde A, et al. Quality of postoperative care after major orthopedic surgery is correlated with both long-term cardiovascular outcome and troponin Ic elevation. Anesthesiology 2010; 113: 529-40. [13] Auroy Y, Benhamou D, Amalberti R. Time to widen our horizons in perioperative medicine: a plea in favor of using patient-centered outcomes. Anesthesiology 2009; 110: 20911. [14] Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, et al. Mortality after surgery in Europe: a 7 day cohort study. Lancet 2012; 380: 1059-65. [15] Gerson C, Sicot C. [Dental accidents in relation to general anesthesia. Experience of mutual medical insurance group]. Ann Fr Anesth Reanim 1997; 16: 918-21. [16] Morisot P. [Complications of local and regional anesthesia. An analysis of closed files of insurance companies]. Cah Anesthesiol 1991; 39: 239-42. [17] Gaba DM. Crisis resource management and teamwork training in anaesthesia. Br J Anaesth 2010; 105: 3-6. [18] Arriaga AF, Gawande AA, Raemer DB, Jones DB, Smink DS, Weinstock P, et al. Pilot testing of a model for insurer-driven, large-scale multicenter simulation training for operating room teams. Ann Surg 2014; 259: 403-10. [19] Auroy Y, Benhamou D, Bargues L, Ecoffey C, Falissard B, Mercier FJ, et al. Major complications of regional anesthesia in France: The SOS Regional Anesthesia Hotline
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Service. Anesthesiology 2002; 97: 1274-80. [20] Metzner J, Posner KL, Lam MS, Domino KB. Closed claims' analysis. Best Pract Res Clin Anaesthesiol 2011; 25: 263-76. [21] Mander R, Smith GD. Saving Mothers' Lives (formerly Why Mothers die): reviewing maternal deaths to make motherhood safer 2003-2005. Midwifery 2008; 24: 8-12. [22] Mehta SP, Eisenkraft JB, Posner KL, Domino KB. Patient injuries from anesthesia gas delivery equipment: a closed claims update. Anesthesiology 2013; 119: 788-95. [23] Cheney FW, Posner KL, Caplan RA, Gild WM. Burns from warming devices in anesthesia. A closed claims analysis. Anesthesiology 1994; 80: 806-10.
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Figure 1
Figure 1. Schematic arborescent representation of the reported events that led to a cardiac
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arrest.
The relative importance of each trajectory is represented by the thickness of the respective branch (n=315).
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Figure 2
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Figure 2. Schematic arborescent representation of the severe systemic complications.
The relative importance of each trajectory is represented by the thickness of the respective branch (n=157).
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Figure 3
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Figure 3. Schematic arborescent representation of the other events.
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The relative importance of each trajectory is represented by the thickness of the respective branch (n=340).
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Graph 1
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Graphic 1. Evaluation of the relation to anesthesia.
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Graph 2
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Graphic 2. Notion of error at the root of the event.
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Annex 1
Annex 1. List of the collected items and codes.
Cardiac arrest 100000
Severe Systemic Complication
200000
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Cardiovascular 110000 Cardiac 111000
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Cardiogenic shock 111100
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Myocardial infarction 111110 Metabolic 111111
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Rythm 111112 Hypoxia 111113
Metabolic 111121
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Rhythm 111122
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Rhythm disorders 111120
M
Anemia 111114
Hypoxia 111123 Anemia 111124
Pulmonar embolism 111130 Gas 111140
Cement 111150
Amniotic111160
Hypovolemia 112000 True 112100 Hemorrhage112110 Relative 112200
Page 24 of 36
Sepsis 112210 3sector 112220 Allergy112230 Sympathetic block 112240
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GA 112241 RA 112242
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Vascular 113000
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Arterial113100 Venous thrombosis113200
an
Pulmonary embolism 113300 Respiratory 120000
Metabolic 121200
Ac ce pt e
Vascular 121300
d
Drug 121100
M
Central 121000
Cancer121400
Infection 121500 Airway 122000
Difficult intubation 122100 Obstruction 122200 laryngeal 122210 tracheal 122220 broncheal 122230 Muscular 123000 Neuromuscular 123100
Page 25 of 36
Myorelaxant 123200 Extended axial anesthesia 123300 Pulmonar 124000 pneumoniae 124100
ip t
inhalation 124200 Pleural 125000
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Pneumothorax 125100
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Hemothorax 125200 Central Nervous System 130000
an
Drug 131000 Convulsions 131100
Vascular 133000
Ac ce pt e
Ischemic 133100
d
Metabolic132000
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Depression 131200
Haemorrhagic 133200 Infection 134000
Gas embolism135000 Renal 140000
functional 141000 renal 142000
obstructive 143000 Digestive 150000 Liver failure 151000 Blunt ischemia152000
Page 26 of 36
Others events 3000 Ophtalmic 3100
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Patient motion 3110 Chemical 3120
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Compression 3130
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Occlusion 3140 Traumatic 3150
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Unlinked to RA 3151 Linked to RA 3152
M
ORL / VA 3200
Mucosal lesion 3211
Ac ce pt e
Neurological 3212
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Dysphonia 3210
Temporo-Mandibular joint 3220 Pharynx 3230 Trachea 3240
Foreign body inhaled or ingested 3250 Neurological peripheral 3300 Position 3310
Compression 3311 Stretching 3312 Ponction 3320 Peripheral catheter / Arterial catheter 3321
Page 27 of 36
Central Catheter 3322 Skin / Soft tissue 3400 Burn 3410 Heater device 3411
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Bistoury 3412 Extravasation 3420
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Peripheral catheter 3421
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Central catheter 3422 Material Section / migration 3430
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Needle Section / migration 3431 KT RA 3432
Head injury 3510
Ac ce pt e
Facial injury 3520
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Musculoskeletal 3500
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KT / Vascular leader 3433
Torso injury 3530
Upper limb injury 3540
Lower limb injury 3550 Impact 35X1
Fall of patient 35X2 Fall object 35X3 Drug3600 Allergy 3610
Known + error 3611 Unknown 3612
Page 28 of 36
Side effects 3620 Error 3630 Dose 3631 Syringe 3632
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Wrong site injection 3633 Surgical site infection 3700
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ATBprophylaxy / therapy OK 3710
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ATBprophylaxy / therapy inadequate 3720 Failure of anesthesia / analgesia 3800
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Awareness 3810 Myorelaxant 3811
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Without myorelaxant 3812
Other technic needed 3821
Ac ce pt e
Surgical difficulties 3822
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Technical failure 3820
Postoperative pain 3823
Surgical site error 3900 Other intervention 3910 Side error 3920
General anesthesia and side error 3921 Wrong initial regional anesthesia 3922
Page 29 of 36
Table 1
Table 1. Collected items presented by sources. Sources
Insurance raw data
Experts interpretations
Age Sex Clinical and ASA class
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demographic Mallampati score characteristics
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Previous Treatment
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Past medical history Surgical specialty
Context specialty
Emergency
an
Number of event per
Time of revelation*
Ac ce pt e
d
M
Anesthetic technique
Type (cardiac arrest, severe complication, other complication, conflict between patient and doctor) Main pathophysiological mechanism
Complication
involved Relation to anesthesia Notion of an error at the root of the event Assessment of severity of disability according to the French
Consequences nomenclature of corporal damage (PFD) (PFD, permanent functional deficit)
Page 30 of 36
* The term "revelation" is not the time of occurrence of the event, but refers to the moment when the practitioner is aware of the
Ac ce pt e
d
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an
us
cr
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symptoms reported by the patient or observed by the health care team.
Page 31 of 36
Table 2
Table 2. Characteristics of the population. Data are expressed in n (%) or mean (SD). Characteristics of the population (n=870) Age (years)
56 (± 18)
466 (53.6%)
Male
401 (46.1%)
Unknown
3 (0.3%)
1
66 (7.6%)
2
64 (7.4%)
an
us
ASA status
Medical history
Ac ce pt e
None
3 (0.3%)
695 (79.9%)
d
Unknown
42 (4.8%)
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3 4
cr
Female
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Gender
20 (2.3%)
Unrelated to the event
185 (21.3%)
Worsening or causing the event
265 (30.5%)
Unknown
400 (46%)
None
3 (0.3%)
Unrelated to the event
73 (8.4%)
Aggravating or causing the event
82 (9.4%)
Unknown
712 (81.8%)
Previous treatment
Data are presented in n (%)
Page 32 of 36
Table 3
Table 3. Total number of events per surgical specialty.
Visceral surgery
171 (19.7%)
Urologic surgery
72 (8.3%)
Endoscopy
48 (5.5%)
Gynecologic surgery
46 (5.3%)
Obstetric surgery
45 (5.2%)
Otolaryngology
39 (4.5%) 35 (4%)
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Vascular surgery
Ac ce pt e
Neurosurgery
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Cardiac surgery
35 (4%)
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Plastic surgery Ophtalmologic surgery
Stomatology
Thoracic surgery
30 (3.4%) 25 (2.9%) 22 (2.5%) 10 (1.1%) 9 (1%)
Interventional radiology
8 (0.9%)
Psychiatry
1 (0.1%)
Unknown
38 (4.4%)
Total
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236 (27.1%)
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Orthopedic surgery
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Specialties (n=870)
870
Data are presented in n (%)
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Table 4
cr
Ac ce pt e
Data are presented in n (%)
us
870
an
Total
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N (%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 3 (0.3%) 3 (0.3%) 5 (0.6%) 6 (0.7%) 8 (0.9%) 10 (1.1%) 20 (2.3%) 44 (5.1%) 59 (6.8%) 75 (8.6%) 55 (6.3%) 91 (10.5%) 109 (12.5%) 126 (14.5%) 112 (12.9%) 121 (13.9%) 20 (2.3%)
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Year 1986 1989 1992 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
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Table 4. Number of events per year in the active file.
Page 34 of 36
Table 5
Table 5. Revelation of the reported events. N (%)
Preoperative
46 (5.3%)
Peroperative
89 (10.2%)
Postoperative
689 (79.2%) 68 (7.8%)
Intensive care
37 (4.3%)
Intermediate care Unit
12 (1.4%)
Ward
232 (26.7%)
Home
132 (15.2%)
an
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Postanesthetic care unit
46 (5.3%) 870
Ac ce pt e
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Total
208 (23.9%)
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Unspecified Unknown
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Revelation
Data are presented in n (%)
Page 35 of 36
Table 6
Table 6. Functional consequences of the reported events. Consequence
PFD 1 - 25
173 (19.9%)
PFD 26 - 50
35 (4%)
PFD 51 - 75
18 (2.1%)
PFD > 76
29 (3.3%)
Death
312 (35.9%)
Unknown
142 (16.3%) 870
Ac ce pt e
d
Data are presented in n (%)
M
Total
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131 (15.1%)
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Recovery without sequelae
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30 (3.4%)
an
None
N (%)
Page 36 of 36
S2352-5568(16)30074-1 http://dx.doi.org/doi:10.1016/j.accpm.2015.11.010 ACCPM 164
To appear in: Received date: Revised date: Accepted date:
7-4-2015 15-6-2015 27-11-2015
Please cite this article as: Boutonnet MathieuTrouiller PierreLopard EricAmalberti Ren´eHouselstein ThierryPasquier PierreAuroy YvesDe Saint Maurice Guillaume Insurance statements from French Anaesthesiologists and Intensivists: a database analysis (2016), http://dx.doi.org/10.1016/j.accpm.2015.11.010 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
*Title page
Title Insurance statements from French Anesthesiologists and Intensivists: a database analysis.
Author names
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Pasquier Pierred, Auroy Yvese, De Saint Maurice Guillaumef.
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Affiliations a
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Boutonnet Mathieua, Trouiller Pierreb, Lopard Ericc, Amalberti Renéc, Houselstein Thierryc,
Department of Anesthesiology and Intensive Care Unit, Percy Military Teaching Hospital,
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101 avenue Henri Barbusse, Clamart, France. e-mail address: [email protected]
Intensive Care Unit, Antoine Béclère University Hospital, 157 Rue de la Porte de Trivaux,
Clamart, France.
M
b
MACSF – Le Sou Médical, 10 cours du Triangle de l’Arche, 92919 La Défense Cedex
d
Intensive care unit, Begin Military Teaching Hospital, 69 avenue de Paris, Saint-Mandé,
France e
Ac ce pt e
d
c
Hospital and Research Division, Head Office of Military Health Service – Direction centrale
du service de santé, Fort-Neuf de Vincennes, Cours des Maréchaux, Vincennes, France. f
Department of Anesthesiology and Intensive Care Unit, Val-de-Grâce Military Teaching
Hospital, 74 boulevard de Port Royal, Paris, France.
Corresponding author Boutonnet Mathieu Department of Anesthesiology and Intensive Care Unit, Hôpital d'Instruction des Armées Percy (Military Teaching Hospital), Clamart, France.
Page 1 of 36
Address: 101 avenue Henri Barbusse, 92140 Clamart, France Phone number: +331 41 46 62 21 Fax number: +331 41 46 64 47
Ac ce pt e
d
M
an
us
cr
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e-mail address: [email protected]
Page 2 of 36
Insurance statements from French Anaesthesiologists and Intensivists: a database analysis
Department of Anaesthesiology and Intensive Care Unit, Percy Military Teaching Hospital,
101 avenue Henri Barbusse, Clamart, France.
b
an
e-mail address: [email protected]
us
a
cr
Pasquier Pierred, Auroy Yvese, De Saint Maurice Guillaumef.
ip t
Boutonnet Mathieua, Trouiller Pierreb, Lopard Ericc, Amalberti Renéc, Houselstein Thierryc,
Intensive Care Unit, Antoine Béclère University Hospital, 157 Rue de la Porte de Trivaux,
M
Clamart, France.
MACSF – Le Sou Médical, 10 cours du Triangle de l’Arche, 92919 La Défense Cedex
d
Intensive care unit, Begin Military Teaching Hospital, 69 avenue de Paris, Saint-Mandé,
d
c
e
te
France
Hospital and Research Division, Head Office of Military Health Service – Direction centrale
f
Ac ce p
du service de santé, Fort-Neuf de Vincennes, Cours des Maréchaux, Vincennes, France. Department of Anaesthesiology and Intensive Care Unit, Val-de-Grâce Military Teaching
Hospital, 74 boulevard de Port Royal, Paris, France.
Corresponding author Boutonnet Mathieu
Department of Anaesthesiology and Intensive Care Unit, Hôpital d'Instruction des Armées Percy (Military Teaching Hospital), Clamart, France. Address: 101 avenue Henri Barbusse, 92140 Clamart, France Phone number: +331 41 46 62 21
Page 3 of 36
Fax number: +331 41 46 64 47 e-mail address: [email protected]
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Introduction
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Since their beginnings, anaesthesia and intensive care have faced substantial risks and the associated management challenges [1]. No one can ignore today that our discipline stands at
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the crossroads of fields as varied as medicine, epidemiology, risk analysis and control, insurance, and justice. Considerable progress has been made regarding anaesthetic risk
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control through technical adaptations (monitoring), the improvement of medical knowledge in
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legislation such as the 1994 decree in France which established pre-anaesthetic consultations and post-anaesthesia care units (PACU), organizational changes including guidelines
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emerging from medical associations and checklists, and cultural changes like the reporting
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and analysis of serious adverse events [2]. However, perioperative adverse events remain frequent, occurring in approximately 30% of hospital admissions, and may be avoided in
Ac ce p
more than 50% of cases [3]. Thus, the efforts to improve our practices should be continued. Risk control cannot be understood without measurement and analysis. However, in France, to the best of our knowledge, there is no national registry for the analysis of liability related to anaesthesia [4]. The aim of this study was to assess if an assurance database could enable the measurement and analysis of the medical risks implicated in anaesthesia and intensive care practices. We performed an assessment of the database of a medical insurance company from a medical viewpoint rather than an insurance one. An agreement was created between the French society of anaesthesiology and intensive care (SFAR) and the MACSF-Sou Medical insurance company to access and analyse the insurance database.
Page 4 of 36
1. Materials and methods 1.1.
Overview of perioperative practices and their
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insurance coverage There were 10,949 anaesthesiologists and intensive care practitioners in France in January
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2014 [5], and of these 4,387 had a private practice (40.1%). The MACSF-Sou Medical
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insurance company covered 43.6% of the anaesthesiologists and intensive care practitioners in France, regardless of their practice status. The MACSF-Sou Medical insurance company
an
covered 1,160 practitioners (26.4%) with a private practice and 3,570 (54.4%) with a public practice. The company was the leading insurance group insuring the public practice of
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anaesthesia and intensive care and the second one for private activities. In the same timeframe, there were 25,802 surgeons in France, including all specialties. Of
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these, 18,015 (69.8%) had a private practice [5]. In 2014, the MACSF-Sou Medical group
te
was the third largest insurance company regarding the coverage of surgical practice. It
Ac ce p
covered 4,270 (16.5%) surgeons in 2014, notably 2,510 (13.9%) with a private practice.
1.2.
Data
Our study is a retrospective analysis of all the statements involving an anaesthesiologist covered by the MACSF-Sou Medical insurance company in metropolitan France between 1986 and 2011. The selection of the appropriate statements was performed as follows: declaration by an anaesthesiologist or an intensive care practitioner to the insurance company of an adverse event (either with medical and legal implications, or not), reclamations or claims addressed to the insurance company by another insurance group, reclamations or claims directly addressed to the insurance company by a patient, reclamations or claims addressed by a patient through the Regional Commissions for Conciliation and Reparation for
Page 5 of 36
Medical Accidents, and claims addressed to the insurance company by the judiciary entities (penal or civil legislation). The MACSF-Sou Medical insurance company collected the declarations through a
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standardized form. An expert senior anaesthesiologist, employed by the insurance company, read this form and summarized the event in a short report, including circumstances. All of
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these adverse event reports were collected in an Excel® database. These data were
1.3.
Assessment agreement
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anonymous as concerns physician and patient names.
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An analytical agreement was concluded between the Sfar and the MACSF-Sou Medical
perform a scientific analysis.
Analysis method
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1.4.
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insurance company. This agreement stated that the Sfar had access to the database in order to
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A group of three expert members of the Sfar, senior anaesthesiologists, have analysed the
Ac ce p
reports in order to perform analysis. Two different experts have read each report. Each expert was asked different questions in a three-step analysis. The first step of the analysis was to describe the circumstances of the event. The second step was to assess the adverse event regarding the type of complication, such as cardiac arrest, severe systemic complication without death, other complications and conflicts. The analysis was performed for each type of event according to a method which assigned a code to each clinical pathway. The encoding method is described below. Finally, in the third step the expert had to evaluate the consequences of the adverse event for the patient, its possible relation to anaesthesia and the occurrence of an error as the initial cause, when possible.
Page 6 of 36
1.5.
Exclusion
Dental traumas and the cases directly related to a regional anaesthesia technique were
1.6.
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excluded.
Collected items
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The data collected mixed factual (clinical and demographic characteristics) and interpretative
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items (results of the expert evaluations). The variables collected are presented in Table 1, classified by origin. The circumstances of the events included the term "observation" which
an
was not the time of occurrence of the event but rather the moment when the practitioner was aware of the symptoms reported by patients or observed by the health care team.
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The second step of the analysis was to code each statement according to the mechanism that led to the event. Each type of event (cardiac arrest, severe systemic complication without
d
death, other complications and conflicts) could be encoded in a dedicated mechanistic tree
te
that allowed encoding for each clinical pathway. The code was designed to describe as
Ac ce p
accurately as possible the trajectory, consequences and circumstances of the event reported in the story. Following this principle, a six-figure code can describe the pathophysiological pathway leading to a serious complication of a significant function. Thus, a laryngeal obstruction of the upper airway responsible for death from respiratory causes would be coded 122210 (1 for death, 2 for Respiratory, 2 for Airway, 2 for Obstruction, 1 for xxx, 0 for not enough information on the precise location of obstruction). It would be 122100 if it was following a difficult intubation, or 211150 if a cement embolism was responsible for a cardiogenic shock not leading to death. The complete list of codes is presented in Annex 1. At the end of the coding process, concordance between the two experts was verified. In case of discordance, the three experts collegially coded the litigious cases.
Page 7 of 36
1.7.
Statistics
Statistical analysis was performed using Microsoft ® Excel ® Version 14.3.2. Data are
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expressed as numbers (%) or means (SD).
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2. Results
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A total of 870 statements were analysed after exclusion of 592 dental injuries and 164 statements related to regional anaesthesia. The events took place between 1986 and 2011.
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Circumstances of the events
The patients involved were predominantly women (sex-ratio 0.86), with a mean age of 56
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years (± 18). ASA status was poorly documented (175/870), as were treatments (158/870) and past medical history (470/870). The characteristics of the population involved in the
d
declarations are summarized in Table 2.
te
The most frequently reported specialties in the declarations were orthopaedic surgery and visceral surgery. However, this does not reflect a rate of sinistrality as we did not have access
Ac ce p
to the total number of procedures performed in each specialty by the practitioners. Table 3 presents the distribution of the declarations per specialty. The context of emergency was found in 90.5% (787/870) of cases. An emergency context was present in 159 cases (18.3%). Table 4 presents the number of events per year. The anaesthetic technique was known in 658 cases (75.6%), and was GA in 506 cases (58.2%), GA associated with RA in 54 cases (6.2%) and RA alone in 98 cases (11.3%). Most of the events were observed in the postoperative period (79.3%). It is important to note that nearly half of the events were declared after discharge from the post-anaesthetic care unit and remarkably 15% after hospital discharge. Table 5 summarizes the time of observation of the declared events.
Page 8 of 36
Description of the events The total number of events reported by the practitioners that finally led to a cardiac arrest was 315 (36.2%). The cause was absolutely undefined in 25 of these cases. A cardiovascular
ip t
origin was identified in the majority of the cases (216/315), representing nearly two-thirds of the total number of the events leading to a cardiac arrest. A relative or true hypovolaemia was
cr
at the root of the complication in 158 of these cases. A respiratory problem was the second type of complication leading to a cardiac arrest, but it was far behind cardiac events (44/315
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cardiac arrests), and neurological events accounted for 20 of the 315 cases. Figure 1 presents
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a tree diagram for the events that led to a cardiac arrest. The importance of each trajectory in terms of number of cases is represented by the thickness of the respective branch.
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The total number of severe systemic complications reported by the practitioners was 157 (18%). Cardiovascular events also represented a major pattern (70/157), but neurological
d
events were almost as frequent (64/157). Respiratory problems were much more rare
te
(18/157). A true or relative hypovolaemia was present in the vast majority of the severe cardiac complications, as in the cases of cardiac arrests. True or relative hypovolaemia
Ac ce p
appeared as a major perioperative concern. However, stroke was also a great concern and accounted for 75% of the neurological complications. Figure 2 is the tree diagram for the events that corresponded to a severe systemic complication. The others events declared by anaesthetists or intensivists that were not classified as severe accounted for 340 cases (39.1%). Almost one-third of these were surgical site infections (105/340), and the second major pattern represented was a peripheral neurological lesion (65/340), mostly related to malposition during surgery. Concerning surgical site infections, the experts could only evaluate the antibiotic management (therapeutic or prophylactic) in 39 of the 105 cases. The antibiotic management was considered inadequate in 15 of these cases. Figure 3 is the tree diagram for the other events.
Page 9 of 36
One hundred and six events (12.2%) were analysed as a conflict between the practitioner and the patient. The total number of events exceeded 870 because some of them were analysed twice in case of associations, such as a conflict associated with a surgical site infection. Most
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of the conflicts (35/106) involved a missed or delayed diagnosis. Consequences of the events
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The consequences were analysed according to the French nomenclature of corporal damage (permanent functional deficit, PFD). A total of 312 patients died (35.9%), including 13
us
newborns. Thirty patients (3.4%) had no consequences and 131 (15.1%) recovered without
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sequelae. Table 6 presents the functional consequences of the declared events. The evaluation of the need for additional care was difficult, but this data was present for 394 patients and the
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experts were able to exclude this requirement for 12 patients.
The experts were able to assess links with anaesthesia in 815 cases (93.7%). This relationship
d
was deemed excluded or doubtful in nearly two-thirds of cases (61%). Figure 4 represents the
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relationship between the reported events and anaesthesia. The notion of an error at the root of the event was evaluable in 594 cases (68.3%). The error
Ac ce p
was deemed probable or certain in a little over a quarter of the cases (27.5%). The type of error could be specified in 200 cases (23%), and routine errors were the most frequent (100/200). Figure 5 represents the evaluation of the notion of errors at the root of the event.
3. Discussion
Key findings Accessing the insurance data enables an innovative approach to analysing anaesthetic risk through a medical prism. The main result we wish to highlight is the growing burden of
Page 10 of 36
delayed complications following anaesthesia. Indeed, our results highlighted the fact that anaesthesiologists have to face situations that extend into the vast perioperative area, and they particularly stressed several insufficiencies in the postoperative period. The medical
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consequences and possible legal consequences are serious, as illustrated by the high rate of mortality (nearly one-third of the patients) involved in the statements analysed. This high rate
cr
of mortality is of course partly explained by the exclusion of the statements for dental lesions. Dental trauma linked to anaesthesia is the first cause of sinistrality in anaesthesiology and a
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well-known concern for insurance companies [6]. However, this phenomenon is well
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described, and French preventive guidelines have been established to diminish this burden [7]. Thus, we decided to exclude these specific injuries from our analysis in order to focus on the
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most serious, though less frequent, events.
The results concerning the statements that involved cardiac arrest signal the importance of
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haemodynamic management and notably of hypovolaemia. It is important to note that we did
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not study per-operative cardiac arrests, but rather statements including a cardiac arrest independent of the time spent since surgery. The French inquiry on anaesthesia-related
Ac ce p
mortality had already stressed the major importance of haemodynamic management and notably perioperative haemorrhage [2]. Nevertheless we would like to point out that the methods used in our study are different for several major reasons. First, we studied raw data regardless of the link to anaesthesia. Second, we studied cardiac arrests which occurred during the entire perioperative period. This can explain why relative hypovolaemia and notably sepsis are great concerns. Third, we studied cardiac arrests, recuperated or not. The same reasons can explain the relative low rate of respiratory problems linked to upper airway management. The aim of the study was not to perform a specific analysis of difficult airway management, but our results may be consistent with a decrease in death or brain damage as a consequence of the development of guidelines and new devices for managing the
Page 11 of 36
difficult airway [8]. A relative or true hypovolaemia was the main clinical pathway that led to a cardiac arrest or a serious systemic complication. This outcome should be carefully considered and should lead to a better evaluation of the haemodynamic status during the per-
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operative and postoperative periods. The second clinical pathway to which we should pay attention is the high rate of serious
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neurological complications, notably stroke, that appeared in the second tree. Stroke is a
recognized complication in cardiac surgery [9]. For several years, stroke has also appeared to
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be a great concern in non-cardiac surgery. The Poise Trial had unintentionally stressed the
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importance of perioperative stroke and its consequences in terms of health burden [10]. One year later, Bateman et al. [11], examining the epidemiology of acute ischaemic stroke in a
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cohort of 371,641 patients undergoing non-cardiac and non-vascular surgery, demonstrated that stroke was an important cause of morbidity and mortality associated with surgery.
d
Indeed, the rate of stroke ranged from 0.2% in patients undergoing total hip replacement to
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0.7% in patients undergoing hemicolectomy. The factors associated with acute ischaemic stroke were age and cardiovascular risk (atrial fibrillation, previous stroke, valvular disease
Ac ce p
and renal disease).
Our study pointed out that the complications following surgery and anaesthesia are often delayed and are difficult to link to the surgery or to the anaesthetic technique. In fact, the sum of the cases with a link to anaesthesia as doubtful, probable or unknown was 35.2%. It is now time to consider two objective points. First of all, patient safety will progress if the perioperative practitioners that anaesthesiologists are truly take into account the postoperative period and the delayed complications. Active postoperative policies have shown some evidence in improving acute and long-term cardiac outcome following major orthopaedic surgery, illustrating that delayed complications should not be considered as a fatality [12]. Second, it is questionable whether or not the attempts to link a delayed complication to a
Page 12 of 36
surgical or an anaesthetic act is of importance. Indeed, our results suggest that whatever this link, anaesthesiologists are directly involved in these delayed complications that sometimes occur long after the surgery, even outside the hospital. This plea for a more adequate
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perioperative management has already been made by some [13]. Our results are consistent with those of the EuSos study that focused on perioperative management after non-cardiac
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surgery in Europe. Revealing a global mortality rate of 4%, higher than expected, the authors advocated placing the notion of perioperative care at the core of care organization [14].
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This study highlights the importance of collaboration between insurance companies and
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medical societies. In the past decades, such an association has already been successfully practiced [15, 16]. Managing perioperative risk is a complex process that requires a
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multimodal approach. In the future, crisis resource management and team training are emerging concepts inherited from the aviation training system that may be of importance for
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patient safety in anaesthesia [17]. To illustrate that insurance companies are interested in
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patient safety, some insurance companies have already adopted dedicated policies for promoting educative programs in crisis resource management for insured practitioners [18].
Ac ce p
We expect that the future will offer many such collaboration opportunities between insurance companies and the medical world with the aim of patient safety. Analysing rare events such as anaesthesia complications is a difficult process and may require a large collection of prospective data over long periods. Different methods of analysis have been developed to overcome these difficulties. Prospective cohort studies have been conducted, despite the difficulties, on the basis of practitioner statements [19]. Another approach to such rare events is collecting and analysing patient plaints, such as performed by the "Closed Claims Project" in the US [20]. Certain countries benefit from national declarative registries that allow a specific focus on rare events related to care [21]. However, in France we do not maintain a national registry focused on liability associated with
Page 13 of 36
anaesthesia [4]. Collaborating with an insurance company is an example of a novel and successful approach for assessing risk and liability related to anaesthesia and intensive care practices. As compared with the “Closed Claims Project,” the method we propose has the
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advantage of including more events than simply the sole cases of claims. As compared with national registries, the data collection is not specifically structured for analysing specific
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events and cannot be used for performing a perfect root-cause analysis. However, this original method allowed us to perform a global assessment of risk and burden associated with
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anaesthesia and intensive care practices, and our results illustrate the efficiency of
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collaborative work between an insurance company and a medical society. Limitations
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The main limitation of our study is the fact that data collection was performed according to an insurer point of view, with a possible triple subjectivity from the declarant, the insurer and
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from the experts who analysed each story. To minimize this bias, we constructed an original
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method for data interpretation. The method was based on the a priori construction of trees describing the various possible mechanisms of occurrence of the events. Each branch of a tree
Ac ce p
was translated into a code whose number of digits matched the number of bifurcations of the branch. The code was designed to describe as accurately as possible the conduct, consequences and circumstances of the reported event. Nevertheless, we failed to identify certain undesirable events such as the implication of equipment problems. For instance, on the basis of the Closed Claim project, patient’s injuries from gas delivery equipment problems are declining over the last decades but remain at the root of serious harm for patients [22]. The database and the method used failed to identify this type of problem. However, we performed a secondary search by keyword and identified only one case of a gas delivery equipment problem, and that was detected and corrected preoperatively, without clinical consequences. Most of the events related to equipment involved burns from warming devices (n=2) or flame
Page 14 of 36
from the conjunction of alcohol and electric cautery (n=1). Usually, burns during anaesthesia are subsequent to the misuse of a device intended to warm the patient [23]. Our study could not confirm this point. Unfortunately, the data collected could not be used to perform a
ip t
systemic risk analysis because of the lack of information. Such an analysis would have been highly hazardous. For the same reasons, the conclusions regarding the notion of error and
cr
relationship with anaesthesia should be considered cautiously. One of the most important
conclusions of this study is the growing area of delayed complications following anaesthesia
us
and surgery. In addition, we showed that it is often difficult to conclude whether the
an
complication is related to anaesthesia, surgery or both. However, as expressed above, patient safety will certainly increase independently of that link, perhaps due to a greater involvement
te
Conclusion
d
M
of anaesthesiologists in the postoperative period.
Ac ce p
Collaborations between insurance companies and medical societies are possible and offer an original point of view from which to assess perioperative risk. This study highlights the importance of delayed complications. The two burdens of particular interest are cardiovascular disease (notably hypovolaemia) and central neurological complications, (notably stroke) that are responsible for a large part of postoperative mortality and morbidity. These complications occur in the vast postoperative period, often late after surgery, sometimes outside the hospital. During this period, the link with surgery or anaesthesia is difficult to establish and probably of low interest, considering that anaesthesiologists are involved in these complications regardless of the link with the anaesthetic act itself. This study is a supplemental argument to plea for a more intense implication of anaesthesia in
Page 15 of 36
postoperative care with the aim of improving patient safety. This is one of the relevant
Ac ce p
te
d
M
an
us
cr
ip t
challenges for our specialty.
Page 16 of 36
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te
d
M
an
us
cr
ip t
[1] Gaba DM. Anaesthesiology as a model for patient safety in health care. Bmj 2000; 320: 785-8. [2] Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, et al. Survey of anesthesia-related mortality in France. Anesthesiology 2006; 105: 1087-97. [3] Wacker J, Staender S. The role of the anesthesiologist in perioperative patient safety. Curr Opin Anaesthesiol 2014; 27: 649-56. [4] Trouiller P, Lopard E, Mantz J, Farman T. De la compliance médicale à l'indemnisation du préjudice. Ann Fr Anesth Reanim 2012; 31: 626-31. [5] INSEE. Médecins suivant le statut et la spécialité en 2014. http://www.insee.fr/fr/themes/tableau.asp?reg_id=0&ref_id=NATTEF06102 (accessed 11/06/2015) [6] Laidoowoo E, Baert O, Besnier E, Dureuil B. Lésions dentaires et anesthésie: épidémiologie et impact assurantiel sur quatre années au CHU de Rouen. Ann Fr Anesth Reanim 2012; 31: 23-8. [7] Nouette-Gaulain K, Lenfant F, Jacquet-Francillon D, Belbachir A, BournigaultNuquet A, Choquet O, et al.Bris dentaitres périanesthésiques : texte court. Ann Fr Anesth Reanim 2012; 31: 213-23. [8] Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology 2005; 103: 339. [9] Pawlaczyk R, Swietlik D, Lango R, Rogowski J. Off-pump coronary surgery may reduce stroke, respiratory failure, and mortality in octogenarians. Ann Thorac Surg 2012; 94: 29-37. [10] Group PS, Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet 2008; 371: 1839-47. [11] Bateman BT, Schumacher HC, Wang S, Shaefi S, Berman MF. Perioperative acute ischemic stroke in noncardiac and nonvascular surgery: incidence, risk factors, and outcomes. Anesthesiology 2009; 110: 231-8. [12] Ausset S, Auroy Y, Verret C, Benhamou D, Vest P, Cirodde A, et al. Quality of postoperative care after major orthopedic surgery is correlated with both long-term cardiovascular outcome and troponin Ic elevation. Anesthesiology 2010; 113: 529-40. [13] Auroy Y, Benhamou D, Amalberti R. Time to widen our horizons in perioperative medicine: a plea in favor of using patient-centered outcomes. Anesthesiology 2009; 110: 20911. [14] Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, et al. Mortality after surgery in Europe: a 7 day cohort study. Lancet 2012; 380: 1059-65. [15] Gerson C, Sicot C. [Dental accidents in relation to general anesthesia. Experience of mutual medical insurance group]. Ann Fr Anesth Reanim 1997; 16: 918-21. [16] Morisot P. [Complications of local and regional anesthesia. An analysis of closed files of insurance companies]. Cah Anesthesiol 1991; 39: 239-42. [17] Gaba DM. Crisis resource management and teamwork training in anaesthesia. Br J Anaesth 2010; 105: 3-6. [18] Arriaga AF, Gawande AA, Raemer DB, Jones DB, Smink DS, Weinstock P, et al. Pilot testing of a model for insurer-driven, large-scale multicenter simulation training for operating room teams. Ann Surg 2014; 259: 403-10. [19] Auroy Y, Benhamou D, Bargues L, Ecoffey C, Falissard B, Mercier FJ, et al. Major complications of regional anesthesia in France: The SOS Regional Anesthesia Hotline
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te
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Service. Anesthesiology 2002; 97: 1274-80. [20] Metzner J, Posner KL, Lam MS, Domino KB. Closed claims' analysis. Best Pract Res Clin Anaesthesiol 2011; 25: 263-76. [21] Mander R, Smith GD. Saving Mothers' Lives (formerly Why Mothers die): reviewing maternal deaths to make motherhood safer 2003-2005. Midwifery 2008; 24: 8-12. [22] Mehta SP, Eisenkraft JB, Posner KL, Domino KB. Patient injuries from anesthesia gas delivery equipment: a closed claims update. Anesthesiology 2013; 119: 788-95. [23] Cheney FW, Posner KL, Caplan RA, Gild WM. Burns from warming devices in anesthesia. A closed claims analysis. Anesthesiology 1994; 80: 806-10.
Page 18 of 36
Figure 1
Figure 1. Schematic arborescent representation of the reported events that led to a cardiac
Ac ce pt e
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an
us
cr
ip t
arrest.
The relative importance of each trajectory is represented by the thickness of the respective branch (n=315).
Page 19 of 36
Figure 2
Ac ce pt e
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Figure 2. Schematic arborescent representation of the severe systemic complications.
The relative importance of each trajectory is represented by the thickness of the respective branch (n=157).
Page 20 of 36
Figure 3
d
M
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cr
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Figure 3. Schematic arborescent representation of the other events.
Ac ce pt e
The relative importance of each trajectory is represented by the thickness of the respective branch (n=340).
Page 21 of 36
Graph 1
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Graphic 1. Evaluation of the relation to anesthesia.
Page 22 of 36
Graph 2
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Graphic 2. Notion of error at the root of the event.
Page 23 of 36
Annex 1
Annex 1. List of the collected items and codes.
Cardiac arrest 100000
Severe Systemic Complication
200000
ip t
Cardiovascular 110000 Cardiac 111000
cr
Cardiogenic shock 111100
us
Myocardial infarction 111110 Metabolic 111111
an
Rythm 111112 Hypoxia 111113
Metabolic 111121
Ac ce pt e
Rhythm 111122
d
Rhythm disorders 111120
M
Anemia 111114
Hypoxia 111123 Anemia 111124
Pulmonar embolism 111130 Gas 111140
Cement 111150
Amniotic111160
Hypovolemia 112000 True 112100 Hemorrhage112110 Relative 112200
Page 24 of 36
Sepsis 112210 3sector 112220 Allergy112230 Sympathetic block 112240
ip t
GA 112241 RA 112242
cr
Vascular 113000
us
Arterial113100 Venous thrombosis113200
an
Pulmonary embolism 113300 Respiratory 120000
Metabolic 121200
Ac ce pt e
Vascular 121300
d
Drug 121100
M
Central 121000
Cancer121400
Infection 121500 Airway 122000
Difficult intubation 122100 Obstruction 122200 laryngeal 122210 tracheal 122220 broncheal 122230 Muscular 123000 Neuromuscular 123100
Page 25 of 36
Myorelaxant 123200 Extended axial anesthesia 123300 Pulmonar 124000 pneumoniae 124100
ip t
inhalation 124200 Pleural 125000
cr
Pneumothorax 125100
us
Hemothorax 125200 Central Nervous System 130000
an
Drug 131000 Convulsions 131100
Vascular 133000
Ac ce pt e
Ischemic 133100
d
Metabolic132000
M
Depression 131200
Haemorrhagic 133200 Infection 134000
Gas embolism135000 Renal 140000
functional 141000 renal 142000
obstructive 143000 Digestive 150000 Liver failure 151000 Blunt ischemia152000
Page 26 of 36
Others events 3000 Ophtalmic 3100
ip t
Patient motion 3110 Chemical 3120
cr
Compression 3130
us
Occlusion 3140 Traumatic 3150
an
Unlinked to RA 3151 Linked to RA 3152
M
ORL / VA 3200
Mucosal lesion 3211
Ac ce pt e
Neurological 3212
d
Dysphonia 3210
Temporo-Mandibular joint 3220 Pharynx 3230 Trachea 3240
Foreign body inhaled or ingested 3250 Neurological peripheral 3300 Position 3310
Compression 3311 Stretching 3312 Ponction 3320 Peripheral catheter / Arterial catheter 3321
Page 27 of 36
Central Catheter 3322 Skin / Soft tissue 3400 Burn 3410 Heater device 3411
ip t
Bistoury 3412 Extravasation 3420
cr
Peripheral catheter 3421
us
Central catheter 3422 Material Section / migration 3430
an
Needle Section / migration 3431 KT RA 3432
Head injury 3510
Ac ce pt e
Facial injury 3520
d
Musculoskeletal 3500
M
KT / Vascular leader 3433
Torso injury 3530
Upper limb injury 3540
Lower limb injury 3550 Impact 35X1
Fall of patient 35X2 Fall object 35X3 Drug3600 Allergy 3610
Known + error 3611 Unknown 3612
Page 28 of 36
Side effects 3620 Error 3630 Dose 3631 Syringe 3632
ip t
Wrong site injection 3633 Surgical site infection 3700
cr
ATBprophylaxy / therapy OK 3710
us
ATBprophylaxy / therapy inadequate 3720 Failure of anesthesia / analgesia 3800
an
Awareness 3810 Myorelaxant 3811
M
Without myorelaxant 3812
Other technic needed 3821
Ac ce pt e
Surgical difficulties 3822
d
Technical failure 3820
Postoperative pain 3823
Surgical site error 3900 Other intervention 3910 Side error 3920
General anesthesia and side error 3921 Wrong initial regional anesthesia 3922
Page 29 of 36
Table 1
Table 1. Collected items presented by sources. Sources
Insurance raw data
Experts interpretations
Age Sex Clinical and ASA class
ip t
demographic Mallampati score characteristics
cr
Previous Treatment
us
Past medical history Surgical specialty
Context specialty
Emergency
an
Number of event per
Time of revelation*
Ac ce pt e
d
M
Anesthetic technique
Type (cardiac arrest, severe complication, other complication, conflict between patient and doctor) Main pathophysiological mechanism
Complication
involved Relation to anesthesia Notion of an error at the root of the event Assessment of severity of disability according to the French
Consequences nomenclature of corporal damage (PFD) (PFD, permanent functional deficit)
Page 30 of 36
* The term "revelation" is not the time of occurrence of the event, but refers to the moment when the practitioner is aware of the
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symptoms reported by the patient or observed by the health care team.
Page 31 of 36
Table 2
Table 2. Characteristics of the population. Data are expressed in n (%) or mean (SD). Characteristics of the population (n=870) Age (years)
56 (± 18)
466 (53.6%)
Male
401 (46.1%)
Unknown
3 (0.3%)
1
66 (7.6%)
2
64 (7.4%)
an
us
ASA status
Medical history
Ac ce pt e
None
3 (0.3%)
695 (79.9%)
d
Unknown
42 (4.8%)
M
3 4
cr
Female
ip t
Gender
20 (2.3%)
Unrelated to the event
185 (21.3%)
Worsening or causing the event
265 (30.5%)
Unknown
400 (46%)
None
3 (0.3%)
Unrelated to the event
73 (8.4%)
Aggravating or causing the event
82 (9.4%)
Unknown
712 (81.8%)
Previous treatment
Data are presented in n (%)
Page 32 of 36
Table 3
Table 3. Total number of events per surgical specialty.
Visceral surgery
171 (19.7%)
Urologic surgery
72 (8.3%)
Endoscopy
48 (5.5%)
Gynecologic surgery
46 (5.3%)
Obstetric surgery
45 (5.2%)
Otolaryngology
39 (4.5%) 35 (4%)
an
Vascular surgery
Ac ce pt e
Neurosurgery
d
Cardiac surgery
35 (4%)
M
Plastic surgery Ophtalmologic surgery
Stomatology
Thoracic surgery
30 (3.4%) 25 (2.9%) 22 (2.5%) 10 (1.1%) 9 (1%)
Interventional radiology
8 (0.9%)
Psychiatry
1 (0.1%)
Unknown
38 (4.4%)
Total
cr
236 (27.1%)
us
Orthopedic surgery
ip t
Specialties (n=870)
870
Data are presented in n (%)
Page 33 of 36
Table 4
cr
Ac ce pt e
Data are presented in n (%)
us
870
an
Total
M
N (%) 1 (0.1%) 1 (0.1%) 1 (0.1%) 3 (0.3%) 3 (0.3%) 5 (0.6%) 6 (0.7%) 8 (0.9%) 10 (1.1%) 20 (2.3%) 44 (5.1%) 59 (6.8%) 75 (8.6%) 55 (6.3%) 91 (10.5%) 109 (12.5%) 126 (14.5%) 112 (12.9%) 121 (13.9%) 20 (2.3%)
d
Year 1986 1989 1992 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
ip t
Table 4. Number of events per year in the active file.
Page 34 of 36
Table 5
Table 5. Revelation of the reported events. N (%)
Preoperative
46 (5.3%)
Peroperative
89 (10.2%)
Postoperative
689 (79.2%) 68 (7.8%)
Intensive care
37 (4.3%)
Intermediate care Unit
12 (1.4%)
Ward
232 (26.7%)
Home
132 (15.2%)
an
us
cr
Postanesthetic care unit
46 (5.3%) 870
Ac ce pt e
d
Total
208 (23.9%)
M
Unspecified Unknown
ip t
Revelation
Data are presented in n (%)
Page 35 of 36
Table 6
Table 6. Functional consequences of the reported events. Consequence
PFD 1 - 25
173 (19.9%)
PFD 26 - 50
35 (4%)
PFD 51 - 75
18 (2.1%)
PFD > 76
29 (3.3%)
Death
312 (35.9%)
Unknown
142 (16.3%) 870
Ac ce pt e
d
Data are presented in n (%)
M
Total
cr
131 (15.1%)
us
Recovery without sequelae
ip t
30 (3.4%)
an
None
N (%)
Page 36 of 36