Are Thoracotomy and/or Intrathoracic Anastomosis Still Predictors of Postoperative Mortality After Esophageal Cancer Surgery?: A Nationwide Study.

BACKGROUND: Intrathoracic (vs cervical) anastomosis and a thoracotomy (vs absence) have previously been associated with increasing postoperative mortality (POM). Recent improvements in surgical practices and perioperative management may have changed these dogmas. OBJECTIVES: The aim of this study was to evaluate the impact of performing intrathoracic anastomosis and/or thoracotomy on POM after esophageal cancer surgery in recent years. METHODS: All consecutive patients who underwent esophageal cancer surgery with reconstruction between 2010 and 2012 in France were included (n = 3286). Patients with a thoracoscopic approach were excluded (n = 4). We compared 30-day POM between patients having received intrathoracic (vs cervical) anastomosis and between those having received a thoracotomy or not. Multivariate analyses and propensity score matching were used to adjust for confounding factors. RESULTS: Patients had either cervical (n = 548) or intrathoracic (n = 2738) anastomosis. Thirty-day POM was higher after cervical anastomosis (8.8% vs 4.9%, P < 0.001). Having received a thoracotomy (n = 3061) was associated with a decreased risk of 30-day POM (5.3% vs 9.3%, P = 0.011). After adjustment for confounding factors, cervical anastomosis was associated with 30-day POM [odds ratio (OR) 1.71; 95% confidence interval (CI) 1.05-2.77); P = 0.032], whereas performing a thoracotomy was not associated with 30-day POM (OR 0.97; 95% CI 0.51-1.84; P = 0.926). CONCLUSIONS: Nowadays, intrathoracic anastomosis provides a lower 30-day POM rate compared to cervical anastomosis, and performing a thoracotomy is not associated with POM. Systematic anastomosis neck placement or thoracotomy avoidance is not a relevant argument anymore to decrease POM.

Is Centralization Needed for Esophageal and Gastric Cancer Patients With Low Operative Risk?: A Nationwide Study.

OBJECTIVE: To investigate the impact of center volume on postoperative mortality (POM) according to patient condition. BACKGROUND: Centralization has been shown to improve POM in esophageal and, to a lesser extent, gastric cancer surgery; however, the benefit of centralization for patients with low operative risk is questionable. METHODS: All consecutive patients who underwent esophageal or gastric cancer surgery between 2010 and 2012 in France were included (N = 11,196). The 30-day POM was compared in terms of the center volume (low: <20 cases per year, intermediate: 20-39, high: 40-59, and very high: ≥60) and stratified according to the Charlson score (0, 1-2, ≥3). The consistency across the esophageal (n = 3286) and gastric (n = 7910) subgroups, and variations between 30-day and 90-day POM were analyzed. RESULTS: Low-volume centers treated 64.2% of patients. A linear decrease in 30-day and 90-day POM was observed with increasing center volume, with rates of 5.7% and 10.2%, 4.3% and 7.9%, 3.3% and 6.7%, and 1.7% and 3.6% in low, intermediate, high, and very high-volume centers, respectively (P < 0.001). Comparing low and very high-volume centers, 30-day POM was 4.0% versus 1.1% for Charlson 0 (P = 0.001), 7.5% versus 3.4% for Charlson 1 to 2 (P < 0.001), and 14.7% versus 3.7% for Charlson ≥3 (P = 0.003) patients. A similar linear decrease was observed in the esophageal and gastric cancer subgroups. Between the low and very high-volume centers, an almost 70% reduction in the relative risk of POM was systematically observed, independent of Charlson score or tumor location. CONCLUSIONS: To improve POM, esophageal and gastric cancer surgery should be centralized, irrespective of the patient's comorbidity or tumor location.

Laparoscopic Gastric Mobilization Reduces Postoperative Mortality After Esophageal Cancer Surgery: A French Nationwide Study.

OBJECTIVE: This study was designed to investigate the impact of laparoscopic gastric mobilization (LGM) on 30-day postoperative mortality (POM) after surgery for esophageal cancer (EC). BACKGROUND: Meta-analyses of nonrandomized studies have failed to demonstrate any significant benefit of hybrid minimally invasive esophagectomy on POM, potentially due to small population samples. Moreover, none of the published randomized trials have been designed to answer this question. METHODS: All consecutive patients who underwent EC resection between 2010 and 2012 in France were included in this nationwide study (n = 3009). Data were extracted from the French National Health Service Database with internal and external quality controls. Patients treated with LGM (LGM group, n = 663) were compared with those treated with open approach (open group, n = 2346). Propensity score matching and multivariable analyses were used to compensate for the differences in baseline characteristics. RESULTS: The 30-day POM rate was 5.2%, significantly lower after LGM, compared with open surgery (3.3% vs 5.7%, P = 0.005), as well as in-hospital (5.6% vs 8.1%, P = 0.028), and 90-day POM (6.9% vs 10.0%, P = 0.016). After propensity score matching, 30-day POM rates were 3.3% versus 5.9%, respectively (P = 0.029). By multivariable analysis, age ≥60 years, malnutrition and cardiovascular comorbidity were independently associated with higher POM, whereas LGM was associated with a decrease in POM (OR 0.60, 95% CI 0.37-0.98, P = 0.041). CONCLUSIONS: This all-inclusive nationwide study strongly suggests that POM is significantly reduced after LGM for EC. This is high valuable evidence that helps decision making regarding the optimal approach for EC surgery.

Mortality after colorectal cancer surgery: a French survey of more than 84,000 patients.

OBJECTIVES: This study aimed to identify risk factors of postoperative 30-day mortality (POM) after colorectal cancer resection. SUMMARY: Meta-analyses have failed to demonstrate any significant benefit of laparoscopy in terms of postoperative mortality. This could be explained by the lack of a large sample size. METHODS: All patients who underwent colorectal resection for cancer between 2006 and 2008 in France were included. Data were extracted from the French National Health Service Database. A multivariate analysis evaluating risk factors for POM was performed including the following factors: age, gender, tumor location, associated comorbidities, emergency surgery, synchronous liver metastasis, malnutrition, and surgical approach. RESULTS: During the 3-year period, a total of 84,524 colorectal resections for colorectal cancer were performed: 22,359 through laparoscopy (26%) and 62,165 through laparotomy (74%). From 2006 to 2008, laparoscopic approach rate increased from 23% to 29% (P < 0.001). POM was 5.0%: 2% after laparoscopy and 6% after laparotomy (P < 0.001). In multivariate analysis, 7 independent factors were significantly associated with a higher POM: age 70 years or more [P < 0.001, odds ratio (OR): 3.28; (3.00-3.59)], respiratory comorbidity [P < 0.001, OR: 3.16; (2.91-3.37)], vascular comorbidity [P < 0.001, OR: 2.66; (2.48-2.85)], neurologic comorbidity [P < 0.001, OR: 1.78; (1.51-2.09)], emergency surgery [P < 0.001, OR: 2.68; (2.48-2.90)], synchronous liver metastasis [P < 0.001, OR: 2.63; (2.41-2.86)], and preoperative malnutrition [OR: 1.33; (1.19-1.50)]. Laparoscopic surgery [P < 0.001, OR: 0.59; (0.54-0.65)] was independently associated with a significant decreased POM. CONCLUSIONS: This all-inclusive national study showed that POM after colorectal cancer surgery is significantly reduced in case of age less than 70 years, elective surgery, and absence of synchronous liver metastasis, malnutrition, respiratory, neurologic, or vascular comorbidity. Furthermore, it is suggested that a laparoscopic surgery is independently associated with a decreased POM. This result, observed at a national level, must be considered when choosing the best surgical approach for colorectal cancer treatment.

Budget impact of intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency in France.

AIMS: This analysis aims to evaluate the budget impact of intravenous iron therapy with ferric carboxymaltose for patients with systolic chronic heart failure and iron deficiency, from the perspective of the French public health insurance. METHODS AND RESULTS: A budget impact model was adapted to forecast the budget impact over 5 years, according to two scenarios: one where patients receive ferric carboxymaltose according to market share forecast and another where patients are not treated for iron deficiency. Clinical data were extrapolated from pooled data from four randomized controlled trials. The time horizon was extended to 5 years by applying transition probabilities estimated from the CONFIRM-HF trial. Epidemiological parameters for France were derived from the literature. Cost parameters were derived from national available databases. In the base case analysis, the modelled 5 year cost difference between the scenarios with ferric carboxymaltose vs. no iron deficiency treatment in a population of 189 334 prevalent and incident patients led to €0.8m savings. The cumulative savings resulted from a reduction in the hospitalization costs associated with worsening heart failure (€-35.8m) as well as a reduction in the follow-up costs (€-2.9m). These cost savings outweighed the costs of ferric carboxymaltose treatment (€37.7m). Sensitivity analyses showed that the budget impact varied from €-34m to €+146m. Parameters with the most impact on the budget were the hospitalization rate for patients not treated for iron deficiency, the number of ambulatory sessions needed, the absence of hospitalization cost differentiation between New York Heart Association classes, and administration settings costs. CONCLUSIONS: Iron deficiency treatment with ferric carboxymaltose in systolic chronic heart failure patients results in an improvement of New York Heart Association class and thereby increases the well-being of the patients, while providing an overall cost saving for the French national health insurance.

Timing of Referral of Patients With Severe Isolated Tricuspid Valve Regurgitation to Surgeons (from a French Nationwide Database).

Series evaluating the results of isolated tricuspid valve surgery (ITVS) are rare and often limited by small sample size, selection bias, and/or long period of enrollment. Based on a mandatory administrative national database, we collected all consecutive ITVS performed in France during a 2-year period (2013 and 2014), the type of intervention, clinical profile, and in-hospital mortality and complications. During the 2-year period, 241 patients underwent an ITVS in France (84 repairs and 157 replacements). In-hospital mortality was high (10%), and most patients experienced at least 1 complication (65%) with a 19% rate of major complications (death, need for dialysis, or need for mechanical support using extracorporeal membrane oxygenation). Consequently, hospital duration was remarkably long (26 ± 40 days). Congestive heart failure at presentation was associated with mortality and major complications rates (both p = 0.01). In conclusion, in a contemporary and consecutive series, ITVS was associated with a high mortality and morbidity predicted by clinical presentation at baseline. Our results suggest that patients are often referred too late and that an earlier intervention may improve immediate and possibly midterm outcomes. With the availability of transcatheter therapies in a near future, optimal timing of intervention in this population will be of utmost importance.

Outcomes of Hospitalised Muscular Dystrophy Patients.

BACKGROUND: In France, referral centres in teaching hospitals were created 10 years ago to provide MD patients with treatments and follow-up designed to prevent complications and improve outcomes. Respiratory failure is a major cause of death among subjects with MD, and its prevention and treatment can serve as a touchstone for assessing the effectiveness of MD care pathways. OBJECTIVE: We report data from a preliminary study of admissions of MD patients in France and of factors associated with mortality, with special emphasis on respiratory failure [RF]. METHODS: Retrospective analysis of the data from the French nationwide hospital database [Programme de M é dicalisation des syst é mes d'information, PMSI] for 2009 and 2010. RESULTS: 7187 admissions of patients with MD were included in the study. Most admissions were to teaching hospitals [5913/7187, 82.3%]. 302 [4.2%] patients were admitted for RF requiring invasive ventilation, 924 [12.9%] for RF requiring only NIV or high-flow oxygen therapy, and 5961 [82.9%] required no respiratory assistance. 494 [6.9%] admissions occurred on an emergency basis. 77/7187 [1.1%] patients died while hospitalised. Teaching-hospital admission was associated with lower frequencies of emergency admission [3.08% vs. 24.5%, p < 0.01] and in-hospital death [0.71% vs. 2.75%, p < 0.01]. CONCLUSIONS: Our data suggest that there is room for improvement in care pathways for MD patients requiring admission. Admission to referral centres may provide the best outcomes.Further studies are needed to assess associations between healthcare pathways and outcomes of MD subjects.

Gender as a Modifying Factor Influencing Myotonic Dystrophy Type 1 Phenotype Severity and Mortality: A Nationwide Multiple Databases Cross-Sectional Observational Study.

BACKGROUND: Myotonic Dystrophy type 1 (DM1) is one of the most heterogeneous hereditary disease in terms of age of onset, clinical manifestations, and severity, challenging both medical management and clinical trials. The CTG expansion size is the main factor determining the age of onset although no factor can finely predict phenotype and prognosis. Differences between males and females have not been specifically reported. Our aim is to study gender impact on DM1 phenotype and severity. METHODS: We first performed cross-sectional analysis of main multiorgan clinical parameters in 1409 adult DM1 patients (>18 y) from the DM-Scope nationwide registry and observed different patterns in males and females. Then, we assessed gender impact on social and economic domains using the AFM-Téléthon DM1 survey (n = 970), and morbidity and mortality using the French National Health Service Database (n = 3301). RESULTS: Men more frequently had (1) severe muscular disability with marked myotonia, muscle weakness, cardiac, and respiratory involvement; (2) developmental abnormalities with facial dysmorphism and cognitive impairment inferred from low educational levels and work in specialized environments; and (3) lonely life. Alternatively, women more frequently had cataracts, dysphagia, digestive tract dysfunction, incontinence, thyroid disorder and obesity. Most differences were out of proportion to those observed in the general population. Compared to women, males were more affected in their social and economic life. In addition, they were more frequently hospitalized for cardiac problems, and had a higher mortality rate. CONCLUSION: Gender is a previously unrecognized factor influencing DM1 clinical profile and severity of the disease, with worse socio-economic consequences of the disease and higher morbidity and mortality in males. Gender should be considered in the design of both stratified medical management and clinical trials.

Economic burden of functional and organic mitral valve regurgitation.

BACKGROUND: Very little is known about the costs of mitral regurgitation (MR) in Europe. AIM: To evaluate the cost of MR from a French National Payer perspective, based on annual costs of surgical and non-surgical patients. METHODS: A 12-month retrospective population-based analysis of patient demographics, outcomes and acute hospital and post-discharge resource utilizations, extracted from the 2009 French Medical Information System. RESULTS: A total of 19,868 patients with MR were identified. Surgical group (n=4099): index hospitalization length of stay (LOS), 17±14.7 days; patients discharged to rehabilitation, 72% (LOS 23±16 days); 12-month rehospitalization rate, 25%; total cost per surgical patient, €24,871±13,940 (ranging from €21,970±11,787 for mitral valve repair [n=2567, 62.6%] to €29,732±15,796 for mitral valve replacement). Non-surgical group (n=15,769): number of hospitalizations over 12 months, 3.1±1.5 (LOS 23.5±20.4 days); admitted to rehabilitation, 24% (LOS 38.8±37.6 days); total cost per patient, €12,177±10,913 (varying between €9957±9080 and €13,538±11,692 for those without and with heart failure [HF], respectively). The total observed cost for 19,868 MR patients over 12 months was €292.8 million: surgical group, €100.8 million; medical group €192.0 million. Patients with MR and HF who were managed medically consumed 45% (€132.3 million) of the overall annual cost of MR. CONCLUSION: The costs of care associated with MR are highly heterogeneous. There are significant differences in costs and resources used between the surgical and medical MR subgroups, with further differences depending on type of surgery and presence of HF.