Surgery In France Research Articles

Detecting Hospital Outliers in Post-Pancreatectomy Care Using Funnel Plots from 2009\u20132018 Based on Nationwide Medico-Administrative Data

ObjectivesOur objective was to identify hospitals with unusual mortality rates for major pancreatectomies over a period of ten years using 30-day mortality data from the French national database.MethodsData for all patients who underwent pancreatectomy were extracted from the national medico-economic database (Programme de Médicalisation des Systèmes d'Information). To identify quality outliers for each hospital, the observed-to-expected 30-day mortality rates were used as a quality indicator.ResultsA total of 19 494 patients underwent a major pancreatectomy in France between January 2009 and December 2018. The overall 30-day mortality rate was 4.8% (n = 944). For the 2009–2014 period, the funnel plot showed that 10 of the 176 hospitals lie outside the central 95% region and 7 lie outside the central 99.8% region. For the 2015–2018 period, out of 176 hospitals, 6 lie outside the central 95% region and 2 lie outside the central 99.8% region. The change in standardized mortality ratios between 2009–2014 and 2015–2018 testing for differences from the overall change, they were there 4 hospitals lie outside the central 95% region and 0 lie outside the central 99.8% region.ConclusionOver time, the improvement in hospital quality was weak. This study suggests that there is a pressing need to reorganize the supply of care for pancreatic surgery in France.

Outpatient shoulder prostheses: Feasibility, acceptance and safety

IntroductionOutpatient surgery in France is defined by the national authority for health (HAS) as a scheduled surgery enabling same-day discharge without any increased risk to the patient. With the advent of enhanced recovery after surgery, outpatient lower limb arthroplasty has become a common procedure. However, only 1.1% of knee arthroplasties in France were performed on an outpatient basis in 2017. Objectives1) assess early morbidity and mortality after outpatient shoulder arthroplasties to validate eligibility and safety criteria; and 2) assess patient acceptance of outpatient surgery. MethodsA single-center study with the following inclusion criteria: primary shoulder arthroplasty, American Society of Anesthesiology (ASA) score I or II, no cognitive impairment, and no coronary artery or thromboembolic diseases. Analgesia was provided by bupivacaine via a peripheral nerve catheter in the first 72 hours followed by oral analgesics. Patients were discharged if the post-anesthetic discharge scoring system (PADSS) was>9/10 and the visual analog scale (VAS) was<5/10. Postoperative telephone interviews were carried out on D1, D2 and D3 to assess pain with the numerical rating scale and to collect data on their analgesic consumption. All patients were seen by an independent observer at one and six months for a clinical and radiologic follow-up and at 90 days during a consultation with the senior surgeon. The primary endpoint was the 90-day morbidity and mortality rate (readmissions, rehospitalizations, and minor and major complications). A satisfaction questionnaire was collected at one and six months. ResultsThirty-six patients were offered an outpatient shoulder arthroplasty between February 2016 and February 2018: 12 (33%) refused with no valid reasons and 24 patients agreed to the procedure (seven hemiarthroplasties, nine anatomic shoulder arthroplasties and eight reverse shoulder arthroplasties). The mean age at surgery was 70 years (55–82), mean body mass index (BMI) was 26 (21–32) and 14 patients were ASA II (66%). Three patients (12%) refused same-day discharge despite a PADSS score>9/10 and adequate pain management. Two patients (8%) were not discharged home on the same day as the surgery for medical reasons (one for pain and one for high blood pressure). No readmissions or complications were reported for the 19 outpatient arthroplasties. None of the outpatients used opioids. All patients were satisfied with their functional outcome, 84% were satisfied with the outpatient management and 17% felt they were insufficiently monitored and regretted that they were not hospitalized. Conclusions1) outpatient shoulder arthroplasty can be safely proposed to selected patients with low comorbidities, regardless of their age and type of implant; 2) the acceptance rate for outpatient shoulder arthroplasty remained low among our patient population. These results should incite us to better educate patients about outpatient surgery. Level of evidenceIV; retrospective study.

Surgical management of endometriotic women with pregnancy intention in France: A national snapshot of centers performing a high volume of endometriosis procedures.

ObjectiveTo provide a snapshot of the surgical management of endometriosis in French high-volume activity centers. MethodsAnalysis of prospectively collected data between November 2015 and May 2017 in 21 centers with a high volume of endometriosis surgery in France. Each facility could include up to 40 patients undergoing laparoscopy for endometriosis. Data were collected before and two months after surgery. Results361 patients were enrolled in the study. Twenty-seven patients (7.48%) were lost to follow-up at the month 2 visit. Endometriosis stage was I-II in 33.70% of patients and III-IV in 66.30%. Uterosacral ligament resection was the most frequently performed procedure (50.97%) followed by rectal surgery (31.58%), ovarian procedures for endometrioma, procedures for ureters (21.33%) and the bladder (11.91%). Antiadhesion agents were employed in 215/361 (59.56%) patients. The median length of hospital stay after surgery was 2 (IQR 1 – 4) days. Post-operative complications were recorded in 9.34% of patients. Rectovaginal fistulae occurred in 8 patients (2.41%), pelvic abscess in 4 (1.20%) and bladder atony in 3 (0.90%). 17 patients (5.14%) required a second surgical procedure after a median time of 31 days (IQR 9 – 81). Two months after surgery, 95.09% of patients reported being satisfied or very satisfied with the surgery. ConclusionOur study shows that surgical management of endometriosis in centers with a high volume of endometriosis surgery, mainly concerns women presenting with severe disease and deep localizations, with an overall risk of major complications inferior to 10% and a high rate of patient satisfaction.

The Dark Age of medieval surgery in France in the first part of Middle Age (500-1000): royal touch, wound suckers, bizarre medieval surgery, monk surgeons, Saint Healers, but foundation of the oldest worldwide still-operating hospital.

During the Middle Ages, the Christian church established itself as the dominant force over all aspects of medieval life, including the practice of medicine. As the Church's influence expanded across Europe, the role of lay practitioners in medicine declined, and clerics gradually assumed the role of healers in surgical practice as the cure of the soul was felt to take precedence over cure of bodily ills. A retrospective analysis of hospital foundation, old-school surgical techniques still used today was performed during the first part of the Middle Age. The Hospital Hotel Dieu in Paris was founded and remains the oldest worldwide still-operating hospital. The monastery became a resting place for travelers, as well as a place of refuge for the sick. As this role expanded, monks often developed considerable surgical expertise. This led to fierce competition for saintly relics and pilgrims. Among the myriad of saints to whom powers of healing were ascribed, the names of Damian and Cosmas figure prominently in medical history. Old-school medieval surgery was also performed with some bizarre techniques such as lip service by wound suckers, cautery, blood-letting, leech therapy, and maggot therapy. This account of surgery before it became scientific is based on a chronology that runs from the Clovis baptism to the reign of Charlemagne; much of the medicine in this period was based on ancient doctrines; indeed, much of the development of medicine in the period called as "Dark Age" was due to the slow and difficult business of recovering and trying to understand ancient medicine.

PSU2 Perioperative Complications of Scoliosis Surgery : Management Strategies and Associated Costs in France

Scoliosis is a spinal deformity that can be treated by complex spine surgery. The objective of this systematic literature review was to assess the perioperative complications associated with scoliosis surgery, their associated costs, and their management in France. A search was performed in Embase and Medline from 2014 to 2018. Adult and pediatric patients with a scoliosis pathology and/or a Scheuermann’s kyphosis that were undergoing ≥4 level spine surgery in France were included. Variables extracted from the studies and analyzed included: age, underlying indication for surgery, number of spine levels operated, operative time and length of stay, peri-operative blood loss and transfusions, complications, costs and management strategies. Out of 733 articles identified, 8 full-text articles were included for evaluation: 2 prospective studies and 6 retrospective studies. The number of patients included was comprised between 40 and 524. Seven studies included pediatric patients. Five studies included patients suffering from adolescent idiopathic scoliosis. The number of spine levels operated was between 4.3 and 13. The follow-up period was between 1 month and 7 years. The complications reported were postoperative infections (N=7), complications associated with spinal implants (N=3), proximal junction kyphosis (N=2), adding-on (N=1), blood transfusions (N=1), neurological complications (N=1), reoperation (N=1). The length of stay was reported in one study (3.5 days) and the operative time was reported in three studies (mean: 212 minutes). Postoperative pain was assessed in three studies using a visual analogical scale (VAS) or the Scoliosis Research Society SRS-22 questionnaires. Quality of life and functional outcomes were reported in two studies using the SRS-22. Management strategies and associated costs of complications associated with scoliosis surgery were not or little reported in the selected studies. A board of experts should be conducted to identify the management strategies and their costs in France.

Impact of Competition Versus Centralisation of Hospital Care on Process Quality: A Multilevel Analysis of Breast Cancer Surgery in France.

Background: The implications of competition among hospitals on care quality have been the subject of considerable debate. On one hand, economic theory suggests that when prices are regulated, quality will be increased in competitive markets. On the other hand, hospital mergers have been justified by the need to exploit cost advantages, and by evidence that hospital volume and care quality are related. Methods: Based on patient-level data from two years (2005 and 2012) we track changes in market competition and treatment patterns in breast cancer surgery. We focus on technology adoption as a proxy of process quality and examine the likelihood of offering two innovative surgical procedures: immediate breast reconstruction (IBR), after mastectomy and sentinel lymph node biopsy (SLNB). We use an index of competition based on a multinomial logit model of hospital choice which is not subject to endogeneity bias, and estimate its impact on the propensity to receive IBR and SLNB by means of multilevel models taking into account both observable patient and hospital characteristics. Results: The likelihood of receiving these procedures is significantly higher in hospitals located in more competitive markets. Yet, hospital volume remains a significant indicator of quality, therefore benefits of competition appear to be sensitive to the estimates of the impact of volume on care process. In France, the centralisation policy, with minimum activity thresholds, have contributed to improving breast cancer treatment between 2005 and 2012. Conclusion: Finding the right balance between costs and benefits of market competition versus concentration of hospital care supply is complex. We find that close to monopolistic markets do not encourage innovation and quality in cancer treatment, but highly competitive markets where many hospitals have very low activity volumes are also problematic because hospital quality is positively linked to patient volume.

Progression and projection for shoulder surgery in France, 2012–2070: Epidemiologic study with trend and projection analysis

IntroductionShoulder surgery has been rapidly expanding over the past 20 years and now makes up a large share of orthopedic surgery practice. Data on how this activity has changed is not available in France due to a lack of registries. The study objectives were to: (1) quantify the number of shoulder surgeries in France, (2) predict how this activity will change over the next 50 years based on extreme scenarios. MethodsThis study involved an analysis of shoulder surgery data taken from the French hospital discharge database (PMSI). Two mathematical scenarios were applied to define the change over time: the first only considered the evolution in the population and changes in the age brackets over time; the second extrapolated the trends observed over the past few years (2012 to 2018). ResultsIn 2018, there were 234,612 procedures coded as primary shoulder surgery procedures in France. This activity increased 24.5% between 2012 and 2018 and is projected to increase 18% to 161% from now to 2050, depending on the scenario (p<0.0001). Rotator cuff surgery procedures were done 173,799 times – of which 61,055 were tendon repair – representing 74% of all shoulder procedures. The scenarios point to an increase of 13.6% to more than 300% (p<0.0001). Primary shoulder arthroplasty corresponded to 17,043 procedures in 2018 (7.3% of all procedures), with a 47% increase between 2012 and 2018. Between 2018 and 2050, the number of total shoulder arthroplasty procedures is expected to increase 31% to 322% (p<0.0001). The total number of revision arthroplasty procedures was 1508, increasing by 39% from 2012 to 2018. There were 14,229 procedures done for anterior or posterior instability in 2018 (6% of total). Bone block procedures made up 53% of these cases. This increased 17% between 2012 and 2018, with a projected increase of 5% to 82% up to 2050 (p<0.01). DiscussionShoulder surgery is the third largest activity in the orthopedic realm after hip and knee surgery, although it has seen the largest increases in recent years. This growth in shoulder procedures should continue over the next decades. Level of evidenceIV, descriptive epidemiology study.

Presentation and outcomes of mitral valve surgery in France in the recent era: a nationwide perspective

ObjectivesUnbiased information regarding the surgical management of patients with mitral regurgitation (MR) at the nationwide level are scarce and mainly US-based. The Programme de Médicalisation des Systèmes d’Information, a mandatory...

Litigation in arthroscopic surgery: a 20-year analysis of legal actions in France

The main objective of this study was to identify the epidemiological characteristics of litigation following arthroscopic procedures, performed in private practice and public hospitals in France. The secondary objective was to establish a risk profile for medical malpractice lawsuits after arthroscopic surgery. All court decisions related to arthroscopic surgery between 1994 and 2020 were collected and reviewed cases from the two main French legal databases (Legifrance and Doctrine). Data were retrospectively collected and included: gender, joint and defendant's specialty involved, reason behind the lawsuit, initial indication and the type of arthroscopic procedure performed. The final verdicts as well as the indemnity awarded to the plaintiff (if any) were recorded. One-hundred eighty cases met the inclusion criteria of the study and were analyzed: 58 cases were before administrative courts and 122 were before civil courts. An orthopaedic surgeon was involved alone or in solidum in 45.6% of cases (82/180), followed by anesthesiologists in 5.6% (10/180). The private surgery center or public hospital were implicated in 63.9% (115/180) of cases. The 2 most common joints involved in litigation following arthroscopic surgery were the knee (82.2%, n = 148) and the shoulder (11.1%, n = 20). The main reasons behind the lawsuit were related to postoperative infection in 78/180 cases and to a musculoskeletal complication in 45/180 cases (25%). A failure to inform was also reported in 34/180 cases (18.9%). Of the 180 cases, 122 cases (67.8%) resulted in a verdict for the plaintiff. The average indemnity award for the plaintiff was 77.984 euros [2.282-1.117.667]. A verdict for the plaintiff was significantly associated with postoperative infection or a wrong-side surgery, while technical error and musculoskeletal complications were more significantly likely to result in a verdict in favor of the defendant (p = 0.003). This study evaluated and mapped lawsuits following after arthroscopic surgery in France over a period of more than 20years. The main joint involved in lawsuits was knee. The main causes of lawsuits following arthroscopic surgery were related to postoperative infection, musculoskeletal complications and failure to inform. Level IV.

Study on a New Energy Device in Bariatric Surgery in France, the Sound Reach™ System

Current laparoscopic bariatric operations (e.g. gastric bypass and sleeve gastrectomies) require systematically the use of an energy device, meant for dissection and coagulation. Several companies make them, the US Medtronic and Ethicon being dominant, with published favorable results. A trial has been conducted with devices created by the company REACH Surgical Inc (Beijin, China): Sound Reach device in two centers in France (Lyon, Saint-Etienne) and three different surgeons. Thirty interventions have been carried out (21 sleeve gastrectomies, 1 bypass, and 8 gastric band removals), 27 F and 3 H, mean age 40, mean weight 99 kg, and mean BMI 40,4. From 0 to 5, the average note for ergonomics has been 3.5, and 4.5 for safety. There was no intra-operative incidents, but a post-operative hematoma treated by surveillance only at D2. The overall impression has been that this device was safe and effective.

A series of severe neurologic complications after bariatric surgery in France: the NEUROBAR Study.

Neurologic complications after bariatric surgery are rare, but can have dramatic consequences. Little data are available on this topic. The aim of the Neurologic complications after BARiatric surgery (NEUROBAR) study was to define, which factors (anthropometric, nutritional, surgical, etc.) were frequently associated with neurologic complications after bariatric surgery. Data were collected by the French Centers of Obesity Care Management hosted in University Hospitals. An online standardized questionnaire was designed and submitted to the 37 French Centers of Obesity Management. This questionnaire included items about patient characteristics, bariatric surgery, neurologic complications, nutritional status, and management. Patients were retrospectively included from January 2010 to November2018. Thirteen centers included 38 patients (34 females and 4 males) with neurologic complications after bariatric surgery. The 2 main bariatric procedures were gastric bypass and sleeve gastrectomy. More than half of the patients with neurologic complications had a surgical complication after bariatric surgery (53%) and gastrointestinal symptoms, including vomiting (53%). Vitamin B deficiencies were frequent (74%) including at least 47% of cases with deficiency in Vitamin B1. Early identification of patients with surgical complications and gastrointestinal symptoms after bariatric surgery could help prevent neurologic complications related to nutritional deficiencies.

A decade in the battlefield (2004–2014): A French military perspective on the high mortality associated with non-exclusively orthopedic or brain combat injuries

BackgroundDuring the last few decades, French armed forces have regularly deployed in asymmetric conflicts. Surgical support for casualties of these conflicts occurs in NATO role 2 and 3 medical treatment facilities (MTF); definitive surgical care occurs in France following a strategic medical evacuation. The aim of this study was to describe the combat injury profile of these soldiers who presented with either non-exclusively orthopedic and/or brain injuries. MethodsThis descriptive study is a retrospective analysis of the surgical management of French casualties performed in role 2 or 3 MTF in Afghanistan, Mali, Niger, Djibouti and the Central African Republic between January 2004 and December 2014. ResultsOne hundred patients were included. Forty had fragment wounds. The most severe lesions were of the head, neck or thorax. The average injury severity score (ISS) was 34.9 (IC 95% 29.8–40). 17 damage control procedures were performed. Thirty patients died with a mean ISS of 61 (IC 95% 56-67); 5 deaths were considered as preventable. The most frequent surgical procedures in the MTF were digestive (n=31) and thoracic surgery (n=19). Thirty patients needed second-look surgery in France; eleven had severe complications. No patient died following medical evacuation to France. ConclusionsResults from this study indicated that the mortality following non-exclusively brain or orthopedic injuries remains high in modern asymmetric conflicts.Level of Evidence IV

A French National Study on Gastropleural and Gastrobronchial Fistulas After Bariatric Surgery: the Impact of Therapeutic Strategy on Healing.

Gastropleural and gastrobronchial fistulas (GPF/GBFs) are serious but rare complications after bariatric surgery whose management is not consensual. The aim was to establish a cohort and evaluate different clinical presentations and therapeutic options. A multicenter and retrospective study analyzing GPF/GBFs after bariatric surgery in France between 2007 and 2018, via a questionnaire sent to digestive and thoracic surgery departments. The study included 24 patients from 9 surgical departments after initial bariatric surgery (21 sleeve gastrectomies; 3 gastric bypass) for morbid obesity (mean BMI = 42 ± 8kg/m2). The GPF/GBFs occurred, on average, 124days after bariatric surgery, complicating an initial post-operative gastric fistula (POGF) in 66% of cases. Endoscopic digestive treatment was performed in 79% of cases (n= 19) associated in 25% of cases (n= 6) with thoracic endoscopy. Surgical treatment was performed in 83% of cases (n= 20): thoracic surgery (n= 5), digestive surgery (n= 8), and combined surgery (n= 7). No patient died. Overall morbidity was 42%. The overall success rate of the initial and secondary strategies was 58.5% and 90%, respectively. The average healing time was approximately 7months. Patients who had undergone thoracic surgery (n= 12) had more initial management failures (n= 9/12) than patients who had not (n= 3/12), p= 0.001. Complex and life-threatening fistulas that are revealed late require a multidisciplinary strategy. Thoracic surgery should be reserved once the abdominal leak heals; otherwise, it is associated with a higher risk of failure.

Bariatric Surgery in France from 1997 to 2018.

Bariatric surgery is 1 of the major treatments of obesity. This study describes the development of the bariatric surgery in France and look at some factors of this evolution. It concerns the activity of all the French hospitals over a 22-year period. Hospitalization databases from 1997 to 2018 have been used to study the evolution of the number of bariatric operations, their types, the characteristics of both patients and hospitals performing this surgery. The number of operations grew from 2800 in 1997 to 52,500 in 2018, with 2 interruptions in this growth, in 2002 and from 2017 to date. The rate of operations is 4 times higher for women than for men, with a peak in the 35-44 age group. The adjustable gastric banding was the most popular operation until 2010, then replaced by sleeve gastrectomy since 2010. Private for-profit hospitals carried out the majority of these operations, even if the public hospitals activity progressed regularly during the past 2 decades. Compared to other countries, the rate of bariatric operations in France is rather high whereas the obesity rate is medium to low. Easy accessibility to bariatric surgery should play a role in the high rate, but specific studies are necessary to evaluate if the operations are delivered adequately to the obese population.

Strong Opioids Rare After Spine Surgery in France

The Back Letter: March 2020 - Volume 35 - Issue 3 - p 28 doi: 10.1097/01.BACK.0000656752.14338.aa

Incidence of acute postoperative endophthalmitis following macular surgery in France between 2006 and 2016.

To report the incidence of acute postoperative endophthalmitis (POE) after macular surgery in France between 2006 and 2016 and to identify associated factors. This retrospective database study included all hospital discharge records involving a surgical procedure for an epiretinal membrane or a macular hole in France from January 2006 to October 2016. Acute POE was identified by two codes in the tenth edition of the International Classification of Diseases within 42days of a macular surgical procedure in the French national administrative database. In France, 152034 macular surgical procedures for epiretinal membranes or macular holes were recorded from 1 January 2006 to 31 October 2016. Suspected acute POE was reported in 381 cases. The incidence of POE was 0.25% overall, 0.30% for epiretinal membrane surgery and 0.14% for macular hole surgery. In multivariable Poisson regression analysis, epiretinal membrane surgery was associated with POE [incidence rate ratio (IRR), 2.24; 95% CI, 1.62-3.11; p<0.001]. For epiretinal membrane surgery, the 2010-2011 period was significantly associated with a higher risk of POE (IRR, 1.66; 95% CI, 1.13-2.42; p=0.03). The incidence of POE after macular surgery was 0.25% overall in France between 2006 and 2016 and twice higher for epiretinal membrane surgery than for macular hole surgery. For epiretinal surgery only, the incidence of POE was higher in 2010-2011 (period of the switch to transconjunctival vitrectomy) than in the rest of the study period.

Progression and projection for hip surgery in France, 2008-2070: Epidemiologic study with trend and projection analysis

IntroductionHip replacement was declared “operation of the century” in tribute to the functional improvement it provides. Frequency is increasing, but it is difficult to estimate the actual number of procedures performed and the expected progression, because of changes in indications and lengthening life-expectancy, and also, in France, because there is no registry. As data are lacking in France, we conducted an investigation 1) to update the number of hip surgeries in France, and 2) to forecast progression over the coming decades, considering extreme scenarios. HypothesisThe number of hip procedures can be expected to increase considerably over the coming 50 years. Material and methodA study was conducted to analyze national coding data for the number of hip surgeries performed in France. Two scenarios were defined: one taking account of population progression and age structure, the other also extrapolating trends observed over recent years. Current hip surgery activity in France was measured, and progression estimated according to population changes. ResultsIn 2018 in France, 183,139 procedures were coded as principally concerning the hip. There was a clear predominance of reconstruction procedures, with 148,965 primary hip replacements, 124,251 of which were total. There were 19,304 hip replacement revision procedures. There were strong regional differences in revision according to the type of center performing surgery (p<0.0001). Between 2018 and 2050, primary hip replacement could be expected to increase by 41.9% or 114.3% and hip surgery overall by 42.0% or 98.3%, depending on the scenario. DiscussionThe present results are subject to future technological breakthroughs and medical discoveries, but forecast a major increase in hip surgery requirements. These results extend the present state of medical knowledge. Level of evidenceIV, descriptive epidemiological study.

P922Presentation and outcomes of mitral valve surgery in France in the recent era

Abstract Background Contemporary and unbiased information regarding the surgical management of patients with mitral regurgitation (MR) at the Nationwide level are scarce. The PMSI, a mandatory administrative database, offers the unique opportunity to assess the presentation and outcomes of all consecutive mitral valve (MV) surgeries performed in France in the contemporary era. Methods We collected all (isolated or combined) MV surgeries performed for MR in France both in public and private hospitals between 2014 and 2016. Based on an algorithm we developed, MR etiology was classified as degenerative (DMR), secondary (SMR) or OTHER (rheumatic, congenital, infective endocarditis or unknown). Results Between January 2014 and December 2016, 18,167 mitral valve surgeries were performed in France (55% repair and 45% replacement; 52% isolated MV surgery). Mean age was 66±12 years and 59% were male. Etiology was DMR in 42%, SMR in 16% and OTHER in 42%. Among DMR, repair rate was 68% overall and 72% in the subset who underwent an isolated MV surgery (70% of all DMR). Repair rates decreased with age, Charlson index and sex (female) (all P&lt;0.0001). Among SMR, a repair was performed in 39% and a combined surgery in 51%. In-hospital mortality and rate of death / readmission for CHF at one year were 3.4% and 13% respectively for DMR (2.4% and 5.5% respectively for isolated DMR) and 7.8% and 17.8% respectively for SMR (5.5% and 12.4% respectively for isolated SMR). Center volume was associated with a lower in-hospital mortality (p=0.002) but not with higher DMR repair rate (P=0.85). Conclusion In this large administrative contemporary nationwide database, 1) DMR surgery was twice as frequent as SMR and more frequently performed isolated; 2) Repair rates in DMR were suboptimal overall but more critically in the elderly and women subsets. 3) Operative mortality and one-year rate of death and readmission were approximately twice as high in SMR than in DMR and overall considerable even for isolated DMR surgery; and 4) In DMR, center volume had no impact on repair rate but an independent impact on outcome. These results underline the need to develop strategies to improve management and outcomes of patients with both degenerative and secondary MR.

Medico-legal claims in bariatric surgery in France between 2010 and 2015.

The practice of bariatric surgery has multiplied 3.5 times in France in the last ten years. The purpose of the study is to analyze medico-legal claims in this area in order to identify lessons to improve patient care. Two visceral surgeons analyzed 358 independent claim files. Age, gender, socio-economic origin, body mass index, surgical history, depression, smoking, anticoagulants, and pre-operative assessment of patients were recorded. The operative indication, the type and date of occurrence of the event, the existence and causes of intra-operative incidents, re-interventions, inter-hospital transfers and deaths were noted. Any anomaly of care, whether noted by the expert or the court, was considered a fault. The types of bariatric procedures included sleeve gastrectomy in 52.1% of cases and gastric bypass in 33.2% of cases. A third of patients (31.2%) had a history of previous abdominal surgery. The main complications were anastomotic leak (48.6%), followed by vomiting, wounds of neighboring organs, and infections. Fault was found in 30.4% of cases: for delay of care (36.8%), surgical clumsiness or ineptitude (15.5%), incorrect indications, lack of patient information. In 6.4% of cases, metabolic deficiencies with encephalopathy developed. The indications of the French High Authority of Health [Haute autorité de santé (HAS)] must be respected and intra-operative difficulties should not be underestimated in patients who have undergone previous surgery. Post-operatively, clinical signs of severity take precedence over complementary examinations, even when negative. Close monitoring is necessary to quickly detect complications that occur outside the facility, whether it is a surgical complication or vitamin deficiency.

RhBMP-2 (Recombinant Human Bone Morphogenetic Protein-2) in real world spine surgery. A phase IV, National, multicentre, retrospective study collecting data from patient medical files in French spinal centres

BackgroundThis is a Phase IV, national, multicentre, retrospective study to observe the real-world use of rhBMP-2 in France. HypothesisThere was no statistical hypothesis, the statistical analyses were descriptive in nature. Patients and methodsData was collected from patient medical files in 10 French spinal centres. Primary objectives were to understand which patients were treated with rhBMP-2, commercialised in Europe as InductOs™ and how rhBMP-2 was used during spinal fusion surgery in France between 2011 and 2012. ResultsFour hundred patients (634 levels) treated with rhBMP-2 were included in the analysis. The most frequent primary diagnostic indication for rhBMP-2 use was degenerative disc disease (DDD; 129/400; 32.3% of patients) followed by spondylolisthesis (119/400; 29.8%), deformity (59/400; 14.8%) and pseudoarthrosis (29/400; 7.3%). The most frequently treated level was L4–L5 (33.8% of levels in 53.5% of patients); followed by L5–S1 (29.8%, 47.3%), L3–L4 (16.7%, 26.5%), and L2–L3 (7.3%, 11.5%), all other levels (less than 5% of patients). No interbody fusion device was used in 42.7% of levels. Wetted matrix of rhBMP-2 was placed in the interbody space in 58.4% of levels (370/634). The most common procedure for rhBMP-2 treatment was posterior lumbar fusion (PLF) (221/634; 34.9% of levels), followed by anterior lumbar interbody fusion (ALIF) (188/634; 29.7%), posterior lumbar interbody fusion (PLIF) (111/634; 17.5%), lateral lumbar interbody fusion (LLIF) (106/634; 16.7%), transforaminal lumbar interbody fusion (TLIF) (4/634; 0.6%) and ‘other’ (4/634; 0.6%). Thirty-one adverse events of Interest (AEI) were recorded in 27 patients. One AEI was considered related to rhBMP-2. Unplanned secondary spine interventions at index level treated with rhBMP-2 were required in 4 patients. DiscussionIn years 2011 and 2012 when the surgeries captured in this retrospective study were done, rhBMP-2 was indicated for single level (L4–S1) anterior lumbar spine fusion as a substitute for autogenous bone graft in adults with DDD. The most common procedure for the treatment with rhBMP-2 was PLF (off-label use), followed by ALIF (on-label use). The safety findings confirm a predictable and manageable safety profile. Level of evidenceIV.