Does Biolox Delta ceramic reduce the rate of component fractures in total hip replacement?

UNLABELLED: Biolox Delta ceramic has been optimized with nano-sized, yttria-stabilized tetragonal zirconium and strontium oxide to help limit cracking propagation. Although its mechanical properties are better than those of earlier generation ceramics, existing data on this material are limited, thus the goals of this study were to determine: 1) the remaining rate of implant fracture; 2) the ideal combination of head diameter and component position. Hypothesis. We hypothesized that the use of the ceramic composite Biolox Delta had reduced the risk of implant fracture. Materials and methods. The bibliographic search (in Pubmed database with the key words «ceramic fracture¼ and «total hip prosthesis ¼) identified 46 articles on fractures in third or fourth generation ceramic components, including 5 involving Biolox Delta. Manufacturer's data and ANSM (Agence nationale de sécurité du médicament et des produits de santé) (National Agency for Safety of Drugs and Medical Products) reports were compared with the few clinical cases published in the literature. Results. According to the manufacturer (CeramTec GmbH, Plochingen, Germany), the use of Biolox Delta ceramic has reduced the rate of femoral head fractures to 0.003% compared to 0.021% with alumina ceramic. The fracture rate of liners has remained stable, at approximately 0.03%. The number of ANSM reports confirmed these tendencies. The rate of head component fractures decreases as the head diameter increases. The quality of impaction on the morse taper (cleanliness of the taper, insertion along the axis) plays an important role. Although it is generally only available for cup sizes above 50mm, a 36-mm head diameter seems to be optimal because it prevents impingement between the cup rim and the neck of the stem, without increasing micro-separation with larger diameters. Conclusion. Although Biolox Delta ceramic is more resistant to fractures than alumina ceramic, it can be fractured under suboptimal implantation conditions including edge loading. Its use requires the same precautions as other hard-on-hard bearings and requires special attention to cup position, insertion on or in morse tapers and adjustment of leg length. LEVEL OF EVIDENCE: V expert's opinion.

Comparison of esCCO and transthoracic echocardiography for non-invasive measurement of cardiac output intensive care.

BACKGROUND: The esCCO monitor (ECG- estimated Continuous Cardiac Output, Nihon Kohden(®)) is a new non-invasive tool for estimating cardiac output (CO). It derives CO from the pulse wave transit time (PWTT) estimated by the ECG and the plethysmographic wave. An initial calibration is needed to refine the relation linking pulse pressure (measured by arterial pressure cuff) to PWTT. To assess the accuracy and reliability of the esCCO system, we performed an analysis of agreement of CO values obtained by transthoracic echocardiography (TTE). METHODS: Thirty-eight intensive care unit patients were prospectively included. CO was determined simultaneously using esCCO (CO(esCCO)) and TTE (CO(TTE)) as our reference method. RESULTS: A total of 103 paired readings from 38 patients were collected. The correlation coefficient between CO(esCCO) and CO(TTE) was 0.61 (P<0.001). The Bland and Altman analysis corrected for repeated measures showed a bias of -1.6 litre min(-1) and limits of agreement from -4.7 to +1.5 litre min(-1), with a percentage error (2 sd/mean CO) of 49%. The correlation for CO changes was significant (R=0.63, P<0.001), but the concordance rate was poor (73%). Polar plot analysis showed an angular bias of -9° with radial limits of agreement from -54° to +36°. The bias appeared to correlate with systemic vascular resistance (R=-0.45, P<0.001). CONCLUSIONS: In critically ill patients, the performance of the esCCO monitor was not clinically acceptable, and this monitor cannot be recommended in this setting. Moreover, the esCCO failed to trend CO data reliably.

Laparoscopic enucleation of pancreatic neoplasm.

BACKGROUND: Enucleation is an alternative procedure for treating benign and borderline neoplasms of the pancreas, which preserves healthy parenchyma and pancreatic function. This study aimed to evaluate the postoperative and long-term results after laparoscopic enucleation. METHODS: Data collected prospectively from 23 consecutive patients who underwent laparoscopic pancreatic enucleation were analyzed. RESULTS: Laparoscopic enucleation was achieved successfully for 21 patients (91.3%). One death (4%) occurred. A postoperative pancreatic fistula was observed in three cases (13%), and was clinically significant in one case (4%). Enucleation was performed for endocrine neoplasm in 15 patients (65%) and for cystic neoplasm in eight patients (35%). All the patients had benign tumors at the final histopathologic diagnosis. During a median follow-up period of 53 months, no patient experienced tumor recurrence or new-onset exocrine or endocrine insufficiency. CONCLUSION: Laparoscopic enucleation is a safe and effective procedure for the radical treatment of benign and borderline pancreatic tumors. The laparoscopic approach seems to be associated with a decrease in operative time, hospital stay, and pancreatic fistula after enucleation. Laparoscopy should become the standard approach in the future for enucleation of presumed benign lesions.

Reduction of the severe sepsis or septic shock associated mortality by reinforcement of the recommendations bundle: a multicenter study.

INTRODUCTION: We determined whether the implementation of a bundle of 10 recommendations leads to the reduction of mortality in ICU patients with severe sepsis or septic shock. METHODS: All patients with severe sepsis or septic shock during two consecutive phases: a 6-month quality control period (observational) and secondly a 6-month intervention period based on the implementation of a bundle of 10 recommendations adapted from the Surviving Sepsis Campaign guidelines (initial bacteriological samples and initiating antibiotics, measurement of arterial lactate, volume expansion > or =20 ml/kg, targeted mean arterial pressure > or =65 mmHg and the assessments of central venous pressure and Scv(O2); glucose control, low doses of corticosteroids, a tidal volume < or =8 ml/kg in mechanically ventilated patients with ALI; adequate use of recombinant human activated protein C) were evaluated in 15 ICUs. The primary endpoint was the 28-day mortality rate and the secondary endpoint was the compliance with the recommendations of the care bundle. MEASUREMENT AND RESULTS: Four hundred and forty-five patients (230 and 215 in the observational and intervention periods, respectively) were included. In the two periods, the patients had similar characteristics. The 28-day mortality rate significantly decreased from 40% in the observational period to 27% in the intervention period (P=0.02). According to each recommendation, compliance with the care bundle was achieved in 9 to 100% of patients. CONCLUSION: The implementation of a care bundle adapted from the Surviving Sepsis Campaign guidelines decreases the 28-day mortality rate in patients with severe sepsis and/or septic shock.

Emergence of the alumina matrix composite in total hip arthroplasty.

Pure alumina ceramic has been in clinical use in orthopaedics since 1971 and, currently, up to 5 million components have been implanted. Alumina offers advantages like stability, biocompatibility and low wear; however, it has limited strength. Applications are limited by design considerations. Engineers in biomaterials have worked on improving the performance of the material by optimising the manufacturing process. To fulfil surgeons' and patients' increasingly exacting requirements, ceramists have also developed a new ceramic composite, the alumina matrix composite (AMC). This material combines the great principles of the reinforcement of ceramics with its tribological qualities and presents a better mechanical resistance than alumina. The examination of the tribological situation of AMC, especially under the challenging conditions of hydrothermal ageing, shows the aptitude of this material in wear applications. The US Food and Drug Administration (FDA) has approved ceramic ball heads articulating against polyethylene inserts. Since its introduction, more than 65,000 ball heads and 40,000 inserts of AMC have been implanted. With a 6-year follow up, no complication has been reported to the manufacturer. Improved toughness and the excellent wear of AMC makes it a potentially more flexible alternative to the more traditional alumina for hip prostheses.

[Laparoscopic treatment of para-esophageal hernias]. / Traitement laparoscopique des hernies hiatales par roulement.

AIM: This retrospective study aims at analyzing the functional results obtained in patients operated by laparoscopy for a para-esophageal hernia. PATIENTS AND METHODS: From 1994 to 2004, 38 patients underwent a laparoscopic procedure for a symptomatic para-esophageal hiatal hernia of at least 3/4 of the proximal stomach: 27 females and 11 males, mean age 65 years (extreme: 22-84). There was no case on emergency, 4 patients had have at least one episode of intrathoracic volvulus. The operation consisted in gastric reduction into the abdominal cavity, excision of the sac, suture of the crura reinforced with a mesh in 6 patients and the construction of a gastric wrap. A postoperative barium swallow was performed on POD 3 in order to confirm the anatomical result. RESULTS: Mean operating time was 157 minutes (75-480), no case was converted into laparotomy. Four postoperative complications were observed (morbidity 10.8%): one gastric perforation diagnosed on POD 1, 2 severe dysphagias linked to the wrap, and one atelectasia. There was no death in this series. Functional results were evaluated by the mean of a questionnaire in 33 patients who had a follow up more than 6 months. Thirty-three questionnaires have been sent, 3 patients were lost and one was dead. Among the 29 patients analyzed, 14 were very satisfied, 11 were satisfied and 3 were deceived by the operation. Best results are obtained in patients with GERD, dysphagia or postprandial cardiothoracic symptoms. CONCLUSION: These results compared to the published data allow us to discuss about indications of surgery, the necessity to removal the hernia sac, and the advantages to reinforce the crura by the mean of a non absorbable mesh.

Laparoscopic adjustable gastric banding results after 2 years with two different band types.

BACKGROUND: Laparoscopic gastric banding is the most common operation in Europe for morbid obesity. Many devices from different companies are now available. The aim of this study was to compare the results over a 2-year period of 2 types of band: the Lap-Band and the Minimizer band. METHODS: In a non-randomized study, 2 consecutive groups were prospectively analyzed. Group A consisted of 120 patients who received the Lap-Band, and group B consisted of 68 patients who received the Minimizer band which contains eyelets. All the bands were placed above the lesser sac by the perigastric approach. RESULTS: 4 early complications were observed in group A (1 phlebitis, 1 pneumopathy and 2 early displacements of the band); and 1 in group B (1 retention of urine). After a follow-up of 2 years, the displacement rate of the band was 10.8% in group A and 0% in group B. One gastric erosion was observed in group B, but not in group A. After 2 years, the average loss of excess weight was 50% in both groups. CONCLUSION: With the Minimizer band, we did not observe any slipping, and the efficacy with respect to weight loss was equivalent to the Lap-Band.

[Surgical management of obstructed colonic cancer]. / Prise en charge du cancer colique en occlusion.

INTRODUCTION: Management of obstructed colonic carcinomas is a surgical challenge because it happens more often in elderly patients. The aim of our study is to assess mortality and morbidity rates of procedures performed in emergency for this pathology. PATIENTS AND METHOD: Between January 1st, 1998 and December 31st 2003, 22 patients underwent an emergency procedure for obstructive colonic obstruction due to an adenocarcinoma. Obstruction was defined as an emesis, distension on examination, no gas or stool since 24 hours and confirmatory plain radiograph film. RESULTS: Twenty patients (91%) underwent surgical procedure and two others received a colonic stent. Eleven patients (50%) underwent left colonic resection and intraoperative colonic cleansing was undertaken in 3 of these patients. One patient underwent a lateral colostomy, three patients (14%) underwent a right colectomy. A Hartmann's procedure was performed in six cases (27%). Morbidity occurred in 23% (50% were from anastomotic complication). Mortality rate was 27% (44% if aged more than 75 years old) (one superior mesenteric ischemia, and five heart and respiratory failures). Two-year survival rate was 61% and five year survival rate was 47%. Median survival was 24 months. CONCLUSION: Our study confirms that obstructed colonic cancer has a bad prognosis because it happens in elderly and not healthy patients. Priority must be given to the restoration of colonic permeability.

[Value of surgical ampullectomy in the management of benign ampullary tumors]. / Intérêt de l'ampullectomie chirurgicale dans la prise en charge des lésions bénignes de l'ampoule de Vater.

AIM OF THE STUDY: To report the results of transduodenal excision (TDE) for tumors of the ampulla of Vater. PATIENTS AND METHODS: From 1998 to 2003, 10 patients underwent a transduodenal excision for presumed benign tumors of the ampulla of Vater. After resection, frozen sections were performed to ensure negative margins. RESULTS: There was no operative mortality. A postoperative pancreatitis occurred in one patient. For nine patients the postoperative course was uneventful. The mean duration of hospital stay was 18 +/-11 days. The final pathology showed adenoma in 8 patients, an adenocarcinoma in one patient and inflammatory lesions in other one. With a mean follow-up of 20 months, endoscopy did not show any recurrence in patients with benign lesion. Patient with an invasive cancer developed recurrence. CONCLUSION: Transduodenal excision is safe and effective treatment for benign ampullary tumors. TDE should be the operation of choice for patients with histologically-proven benign ampulloma, staged as uT1 by endoscopic ultrasound. This approach could reduce the rate of pancreaticaduodenoctomy performed for benign ampullomas.

[Clinical practice guidelines: 2004 Standards, Options and Recommendations for the management of patient with adenocarcinoma of the stomach--radiotherapy]. / Recommandations pour la pratique clinique : standards, options et recommandations 2004 pour la prise en charge par radiothérapie des patients atteints d'adénocarcinomes de l'estomac (cancers du cardia, autres types histologiques exclus).

CONTEXT: "The Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of French Cancer Centers (FNCLCC), the 20 French regional cancer centers, and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. OBJECTIVES: To elaborate clinical practice guidelines for patients with stomach adenocarcinoma. These recommendations cover the diagnosis, treatment and follow-up of these tumors. METHODS: The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. The Standards, Options and Recommendations are thus based on the best available evidence and expert agreement. RESULTS: Adjuvant radiation therapy alone is not a standard treatment for patients with stomach adenocarcinoma. Adjuvant concomitant chemoradiotherapy is not a standard treatment for patients with stage II or III stomach adenocarcinoma R0, with Dl or D2 lymphadenectomy who have undergone surgery. Following surgical resection, adjuvant concomitant chemoradiotherapy should be proposed to patients without denutrition with a lymphadenectomy < Dl (fewer than 15 lymph nodes examined) and those with T3 and/or N+ tumours following the protocol used in the MacDonald trials (SWOG-9008) (Level of evidence B1). Adjuvant concomitant chemoradiotherapy can be administered to patients without denutrition with DI or D2 lymphadenectomy and with involvement of regional lymph nodes (N2 or N3).

[Laparoscopic pancreatectomy: report of 22 cases]. / Les pancréatectomies laparoscopiques. A propos d'une expérience de 22 cas.

OBJECTIVE: To evaluate results of laparoscopic pancreatectomy for benign lesions of the pancreas. Peri-operative data, surgical outcomes and techniques are presented. PATIENTS AND METHODS: Eighteen women and four men underwent laparoscopic pancreatectomy and were collected retrospectively from 1999 to 2003. RESULTS: Laparoscopic pancreatectomy was attempted in 22 patients and completed successfully in 18: 10 enucleations, three distal pancreatectomies, four left pancreatectomies and one total pancreatectomy for endocrine and cystic tumors. Left and distal pancreatectomies were performed with preservation of the spleen. Four patients were converted (one enucleation, one whipple procedure and two left pancreatectomy). There was no mortality; the post-operative morbidity included two pancreatic leaks and one case of half splenic infarction. The median length of hospital stay was 12 days. CONCLUSION: Patients appear to benefit from laparoscopic pancreatectomy for pancreatic benign tumors.

[Semi-automatic measurements of hepatic lobes. Application to study of liver volumes. Analysis of 50 computed tomography of normal liver]. / Mesure semi-automatique des différents lobes hépatiques. Application à la recherche d'une corrélation entre volumes des lobes du foie. Une étude sur 50 angioscanners de foies sains.

OBJECTIVE: Healthy and pathological hepatic volumetry can be of great interest in Liver pathology and treatment. We studied the hepatic segmentation in order to verify if it is possible to estimate the volume of one lobe, when the volume of the other lobe or the total liver is known. PATIENTS AND METHODS: We studied 50 normal hepatic angiotomographies. For each exam and using the Couinaud classification, we measured the total hepatic volume, the right lobe, the left lobe and the caudate lobe volumes. We used a software called "Hepato" developed in order to quantify automatically CTScan images of the liver. We performed a linear regression analysis (least squares method) and calculated the determination coefficient to study the correlation between the different volumes. RESULTS: The mean total hepatic volume was 1497 cm3. We obtained for the right lobe 1231 cm3, 226 cm3 for left lobe, and 39 cm3 for the caudate lobe. Moreover there was a weak correlation between these volumes. CONCLUSION: Exact volume estimation of an hepatic lobe in one patient can not be obtained from the total hepatic volume. However, theses volumes can only be measured from three-dimensional images. Since classical image editing tools are time request, it becomes impossible to utilize them in a clinical routine to get the different volumes of the Liver. Thus, a software dedicated for liver parenchyma recognition is necessary.

[Contribution of endorectal ultrasonography in preoperative evaluation for very low rectal cancer]. / Apport de l'échographie endorectale dans le bilan préopératoire des cancers du très bas rectum.

UNLABELLED: Abdominoperineal resection is the standard treatment of very low rectal carcinoma. Pretherapeutic evaluation of locoregional extension relies mainly on digital rectal examination. The interest of endorectal ultrasonography to assess lateral and inferior margins is still to be determined. AIM OF THE STUDY: To assess the ability of endorectal ultrasonography to evaluate the possibility of conservative anal sphincter surgery. PATIENTS AND METHODS: Between April 1996 and June 1998, 34 patients (20 men, 14 women, mean age: 61 years, range: 43-80) have been treated for rectal adenocarcinoma. Endorectal ultrasonography was made with a linear probe (EUP-U33). Before treatment, the mean distance between the lower pole of the tumor and the anal verge was 3.9 cm (range: 2-5), and between the lower pole and the puborectalis sling 2.3 mm (range: 0-7). A uTN classification was made. Preoperative treatment was radiotherapy (40 Gy in 4 patients, 60 Gy in 24 patients), or radiochemotherapy (6 patients). Pre- and post-radiotherapy endorectal ultrasonography results were compared to the patholocical analysis of operative specimen. RESULTS: Wall infiltration was correctly evaluated in 57% of patients after radiotherapy. In 26/34 cases, a safe plane existed before and after radiotherapy, and correlation of endorectal ultrasonography with histology was 96%. For patients without safe plane, correlation with histology was 75%. CONCLUSION: For very low rectal tumors, with an aggressive sphincter conservation approach, endorectal ultrasonography allows to assess sphincter invasion with 96% fiability when safe plane exists.

Resection of noncolorectal and nonneuroendocrine liver metastases: late metastases are the only chance of cure.

Resection of liver colorectal metastases allows a 5-year survival in 25% to 35% of patients. The outcome of patients with noncolorectal metastases is unknown because of the heterogeneity of this group. The aim of this retrospective study was to evaluate predictive factors of survival in patients who underwent resection of noncolorectal and nonneuroendocrine (NCRNE) liver metastases. From 1980 to 1997, 284 patients underwent hepatectomy for liver metastases of whom 39 (25 men and 14 women, mean age 55 years) had curative resection for NCRNE liver metastases. No patients had extrahepatic disease. The primary tumors were gastrointestinal (n = 15), genitourinary (n = 12) and miscellaneous (n = 12). The mean number of metastases was 1.8, and the mean size of the lesions was 51 mm. The median disease-free interval was 27 months. Twenty patients had a major hepatectomy and 19 a minor resection, with simultaneous resection of the primary in 6 cases. Overall survival was evaluated using the Kaplan-Meier method. There was no operative mortality, and 8% morbidity. The survival at 1, 3, and 5 years was 81, 40, and 35%, respectively. Patients with a disease-free interval higher than 24 months had a greater survival rate than those with a disease-free interval of less than 24 months (100% vs. 10%; p = 0.0004). Survival was not significantly influenced by age, sex, type of primary tumor, number, size and localization of metastases, type of hepatectomy, or blood transfusion. Resection of NCRNE liver metastases should be justified for patients without extrahepatic disease and resectable metastases, especially for those who have a disease-free interval of more than 24 months.