A new compression system for treatment of venous leg ulcers: a prospective, single-arm, clinical trial (FREEDOM).

OBJECTIVE: To evaluate the efficacy, tolerability and acceptability of a new multicomponent compression system in one bandage for the local treatment of patients with venous leg ulcers (VLUs). METHOD: This was an international, prospective, non-comparative, clinical trial, conducted in France and Germany. Eligible participants had a VLU with a wound area of 2-20cm2, lasting for a maximum of 24 months. For a period of 6 weeks, patients were treated with a new multicomponent compression system in one bandage which was worn day and night, providing high working pressure and moderate resting pressure (UrgoK1). Clinical assessments, wound measurement and photographs were planned at weeks 1, 2, 4 and 6. The primary endpoint was the relative wound area reduction (RWAR) after 6 weeks of treatment. Secondary endpoints included wound closure rate, oedema resolution, change in patient's health-related quality of life (HRQoL), acceptability, adherence to the compression therapy, local tolerance, and physician's overall satisfaction with the evaluated compression system. RESULTS: A cohort of 52 patients (52% female, mean age 75.4±13.0 years) with VLUs, including oedema in 58% of cases, were recruited from 22 centres. At baseline, 42 patients had already been treated with a different compression system. VLUs had been present for 5.6±4.9 months and had a mean area of 5.7±4.3cm2. After 6 weeks of treatment, a median RWAR of 91% (interquartile range: 39.4; 100.0) was achieved. Wound closure was reported in 35% of patients. A RWAR ≥40% at week 4, predictive of wound healing at 12 weeks, was achieved in 62% of patients. At the final visit, oedema present at baseline was resolved in 57% of patients. Substantial improvements in the HRQoL of the patients were reported with a decrease of the pain/discomfort and anxiety/depression dimensions. Comfort in wearing the evaluated system was reported as 'very good' or 'good' by 79% of patients, resulting in a high patient adherence to compression therapy. Compared to previous compression systems, half of the patients reported more ease in wearing shoes, and greater satisfaction and comfort with this new system. Nine non-serious adverse events related to the device or its procedure occurred in seven patients. At the final visit, the majority of the physicians were 'very satisfied' or 'satisfied' with the new compression system overall. CONCLUSION: The new multicomponent compression system in one bandage has been shown to promote rapid healing of VLUs, reduce oedema, improve HRQoL and to be well tolerated and accepted. It appears to be a viable alternative to existing compression systems.

Moving Toward Empirically Based Standardization in the Diagnosis of Delayed Ejaculation.

BACKGROUND: Criteria for delayed ejaculation (DE) rely on a long ejaculation latency (EL) time, lack of control/advancement regarding ejaculation, and associated bother/distress; yet, few studies have investigated these criteria in men who indicate the desire to ejaculate sooner during partnered sex. AIM: To help standardize criteria for DE by better understanding characteristics of men who desire to ejaculate sooner during partnered sex in terms of their EL, reported ejaculatory control, and level of bother/distress, as well as their perceptions of typical and ideal ELs for men in general and of ELs for men with premature ejaculation (PE). METHODS: A total of 572 men recruited through social media responded to an online survey regarding their EL, as well as typical, ideal, and PE ELs of men in general. They also rated (i) their ability to control and/or advance ejaculation and (ii) their level of associated bother/distress. 4 comparison groups were then established: men with probable DE (with [DE1] and without [DE2] ejaculatory control issues), a reference group with no ejaculatory disorders, and men who identified as having PE. OUTCOMES: To demonstrate differences in EL, ejaculatory control, and bother/distress between men with delayed ejaculation and the control and PE reference groups. RESULTS: ELs for men with probable DE were twice as long as those with no ejaculatory disorders. When probable DE men were further subdivided into DE2 and DE1, differences were greater for the DE2 group. DE2 men also differed significantly from the reference group on ejaculatory control/advancement but not on bother/distress. Both DE and reference groups differed from the PE group. CLINICAL IMPLICATIONS: Using both EL and ejaculatory control are useful in distinguishing men with delayed ejaculation from men without delayed ejaculation. STRENGTHS & LIMITATIONS: A sizable sample drawn from a multinational population powered the study, whereas the use of social media for recruitment limited the generalizability of findings. CONCLUSION: Both EL and ejaculatory control differentiate men with probable DE from a control reference group having no ejaculatory disorders. Differences in bother/distress did not emerge as significant. Implications for diagnosing men with DE are presented. Rowland DL, Cote-Leger P. Moving Toward Empirically Based Standardization in the Diagnosis of Delayed Ejaculation. J Sex Med 2020;17:1896-1902.

Estimations of Typical, Ideal, Premature Ejaculation, and Actual Latencies by Men and Female Sexual Partners of Men During Partnered Sex.

BACKGROUND: The ejaculation latency (ELT) criterion for men with premature ejaculation (PE), including its 2 major subtypes of lifelong and acquired, relies heavily on expert opinion, yet such information represents only one source of data for this determination; furthermore, information regarding ELTs for PE within specific subgroups of men (eg, gay, bisexual) has been lacking. AIM: To obtain data regarding men's lived experiences and expectations regarding typical ejaculation, ideal ejaculation, and PE and (for men) self-reported ejaculatory latencies during partnered sex across a variety a groups, including men vs women (ie, sexual partners of men), men with and without PE, and straight vs gay/bisexual men. METHODS: We recruited 1,065 men and sexual partners of men, asking them to estimate typical ejaculation, ideal ejaculation, and PE and (for men) self-latencies through an online survey posted on social media. Demographics, sexual identity, and sexual response data were also collected. RESULTS: Typical and self-reported ELTs were closely aligned with those reported in the literature, with ideal ELTs generally longer than typical ELTs. Median PE ELTs were consistently estimated around 1.5 min, with nearly all subgroups-men vs women; straight vs gay; PE and non-PE men-showing alignment on this criterion. Men with lifelong PE did not differ from men with acquired PE in either their PE ELT estimation or their self-reported ELT. CLINICAL IMPLICATIONS: The data support the idea of extending the latency cutoff for establishing a PE diagnosis beyond the current 1-minute threshold. STRENGTHS & LIMITATIONS: A large sample size drawn from a multinational population powered the study, whereas the use of social media for recruitment and lack of inclusion of lesbian and asexual individuals may have missed relevant data from some who have had sexual experience with men. CONCLUSION: Straight and nonstraight men do not differ in their ELT estimations. In addition, the use of different ELT criteria for lifelong vs acquired PE may be unnecessary. Côté-Léger P, Rowland DL. Estimations of Typical, Ideal,Premature Ejaculation,and Actual Latencies by Men and Female Sexual Partners of Men During Partnered Sex. J Sex Med 2020;17:1448-1456.

Global perspectives on the three criteria for premature ejaculation: An observational study of ejaculatory latency, ejaculatory control and bother/distress.

Criteria for premature ejaculation (PE) were established using Western-based samples, yet these criteria are applied worldwide for its diagnosis. This study (a) determined whether men from various world regions differ/agree on their views of ejaculation latency (ELT) and their perceptions of ejaculatory control and bother/distress, the three criteria for PE, and (b) compared PE and non-PE men across worldwide regions on these measures. 1,065 participants were recruited via social media to respond to a survey about men's typical, ideal and PE ELTs, about their own ELT, and about perceptions of ejaculatory control and bother/distress related to PE. Responses from men from four worldwide regions were compared to a reference group of North American/European men, and PE men were compared with non-PE men across three world regions. Results showed that most world region groups showed similarity in ELT estimations. The Sub-Saharan group focused more heavily on the importance of ejaculatory control. Both ELT and ejaculatory control differed between PE and non-PE groups in all regions assessed. In conclusion, perceived ELTs and ejaculatory control show substantial consistency across world regions despite geo-cultural variations and traditions. Such findings argue for the universality of the concepts of ELT, control and bother/distress related to PE.

Impact of a prophylactic combination of dexamethasone-ondansetron on postoperative nausea and vomiting in obese adult patients undergoing laparoscopic sleeve gastrectomy during closed-loop propofol-remifentanil anaesthesia: A randomised double-blind placebo-controlled study.

BACKGROUND: In obese patients, the incidence of postoperative nausea and vomiting (PONV) following sleeve gastrectomy under titration of total intravenous anaesthesia (TIVA) and the relevance of risk factors to indicate prophylaxis is unknown. OBJECTIVES: The hypothesis was that after automated TIVA, prophylaxis reduces PONV following laparoscopic sleeve gastrectomy. Our objective was to determine the incidence of PONV and evaluate the efficacy of dexamethasone and ondansetron as prophylaxis when automated intravenous anaesthesia is employed. DESIGN: A randomised, placebo-controlled, single-centre, double-blinded study. SETTING: Secondary care centre in New Caledonia from June 2013 to January 2014. PATIENTS: A total of 122 patients were randomised and 117 (92 women) were included in the analysis (58 in the prophylaxis group and 59 in the placebo group). Eligibility criteria included at least two of the known risk factors for PONV: female sex, nonsmoking status, prior history of PONV or motion sickness and expected postoperative opioid analgesia. Exclusion criteria included disorders limiting the use of the bispectral index. INTERVENTIONS: All patients received propofol and remifentanil controlled by the same automated system during induction and maintenance of general anaesthesia. The controller modifies the calculated effect-site concentrations according to bispectral index values. Patients received either intravenous dexamethasone 4 mg after tracheal intubation and ondansetron 4 mg during skin closure, or placebo. MAIN OUTCOME MEASURES: The primary endpoint was the cumulative incidences of 24-h PONV and severe PONV (vomiting or nausea with a score of ≥4 on an 11-point verbal rating scale). Data are presented as percentage (95% confidence interval). RESULTS: PONV in the first 24 h occurred in 45 (34 to 60)% of patients who received prophylaxis and 54 (41 to 67)% in the placebo group (P = 0.35). The numbers of patients who suffered severe PONV [19 (10 to 32)% in the prophylaxis group vs. 20 (11 to 33)%, P = 1, in the placebo group] and who required rescue antiemetic drugs [55 (41 to 68) vs. 63 (49 to 75)%, P = 0.46] were similar between the groups. CONCLUSION: The combination of dexamethasone and ondansetron was not effective in preventing PONV or severe PONV in obese patients undergoing laparoscopic sleeve gastrectomy after TIVA. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01876290.

Burden of diabetic foot disorders, guidelines for management and disparities in implementation in Europe: a systematic literature review.

The study aimed to assess the economic and quality of life burden of diabetic foot disorders and to identify disparities in the recommendations from guidelines and the current clinical practice across the EU5 (Spain, Italy, France, UK and Germany) countries. Literature search of electronic databases (MEDLINE®, Embase® and Cochrane Database of Systematic Reviews) was undertaken. English language studies investigating economic and resource burden, quality of life and management of diabetic foot disease in the EU5 countries were included. Additionally, websites were screened for guidelines and current management practices in diabetic foot complication in EU5. Diabetic foot complications accounted for a total annual cost of €509m in the UK and €430 per diabetic patient in Germany, during 2001. The cost of diabetic foot complications increased with disease severity, with hospitalizations (41%) and amputation (9%) incurring 50% of the cost. Medical devices (orthopaedic shoes, shoe lifts and walking aids) were the most frequently utilized resources. Patients with diabetic foot complications experienced worsened quality of life, especially in those undergoing amputations and with non-healed ulcers or recurrent ulcers. Although guidelines advocate the use of multidisciplinary foot care teams, the utilization of multidisciplinary foot care teams was suboptimal. We conclude that diabetic foot disorders demonstrated substantial economic burden and have detrimental effect on quality of life, with more impairment in physical domain. Implementation of the guidelines and set-up of multidisciplinary clinics for holistic management of the diabetic foot disorders varies across Europe and remains suboptimal. Hence, guidelines need to be reinforced to prevent diabetic foot complications and to achieve limb salvage if complications are unpreventable.

Emergency circulatory support in refractory cardiogenic shock patients in remote institutions: a pilot study (the cardiac-RESCUE program).

AIMS: Temporary circulatory support with extracorporeal membrane oxygenation (ECMO) is often the only alternative for supporting patients with refractory cardiogenic shock (RCS). In practice, this strategy is limited to a small minority of patients hospitalized in tertiary-care centres with ECMO programs. The cardiac-RESCUE program was designed to test the feasibility of providing circulatory support distant from specialized ECMO centres, for RCS patients in remote locations. METHODS AND RESULTS: From January 2005 to December 2009, hospitals without ECMO facilities throughout the Greater Paris area were invited to participate. One hundred and four RCS cases were assessed and 87 consecutively eligible patients (mean age 46 ± 15 years, 41% following cardiac arrest) had ECMO support instituted locally and were enrolled into the program. Local initiation of ECMO support allowed successful transfer to the tertiary-care centre in 75 patients. Of these, 32 patients survived to hospital discharge [overall survival rate 36.8%, 95% confidence interval (CI) 27.4-46.2]. Independent predictors for in-hospital mortality included initiation of ECMO during cardiopulmonary resuscitation [hazard ratio (HR) = 4.81, 95% CI 2.25-10.30, P < 0.001] and oligo-anuria (HR = 2.48, 95% CI 1.29-4.76, P = 0.006). After adjusting for other confounding factors, in-hospital mortality was not statistically different from that of 123 consecutive patients who received ECMO at our institution during the same period (odds ratio 1.48, 95% CI 0.72-3.00, P = 0.29). CONCLUSION: Offering local ECMO support appears feasible in a majority of RCS patients hospitalized in remote hospitals. In this otherwise lethal situation, our pilot experience suggests that over one-third of such patients can survive to hospital discharge.

[Not Available]. / Indications des assistances circulatoires dans le traitement de l'insuffisance cardiaque chronique.

Indications of assist devices concern (a) patients with severe/endstage heart failure on waiting list for heart transplantation a bridge to transplant"; (b) " Bridge to recovery" for patients at imminent risk of death due to acute cardiac failure; (c) "Destination therapy" with chronic implantation due to the imbalance between needs and scarcity of cardiac donors. Classical criteria of implantation correspond to severe heart failure resistant to available therapies. In order to avoid too advanced situations, many investigators recommend to discuss assist devices in patients who are dependent on inotropic support or in whom a progressive increase in inotrope doses is needed to maintain an adequate hemodynamic status. Choice of devices includes pneumatic paracorporeal/intracorporeal machines or electromechanical devices. In case of right and left cardiac failure, biventricular assist devices are needed. A significant reduction in death while on waiting list for heart transplant has resulted from technological progresses in assist devices. However; the benefit/risk must be evaluated individually, taking into consideration contraindications and complications such as thrombosis, bleeding, stroke or infection.

Venoarterial extracorporeal membrane oxygenation support for refractory cardiovascular dysfunction during severe bacterial septic shock.

OBJECTIVES: Profound myocardial depression can occur during severe septic shock. Although good outcomes of venoarterial extracorporeal membrane oxygenation-treated children with refractory septic shock have been reported, little is known about adults' outcomes. This study was designed to assess the outcomes and long-term health-related quality-of-life of patients supported by venoarterial extracorporeal membrane oxygenation for refractory cardiac and hemodynamic failure during severe septic shock. DESIGN: A retrospective, single-center, observational study and a cross-sectional survey to assess health-related quality of life by the Short Form-36 questionnaire and frequencies of anxiety, depression and posttraumatic stress disorder symptoms by the Hospital Anxiety and Depression Scale and the Impact of Event Scale, respectively. SETTING: A 26-bed tertiary intensive care unit in a university hospital. PATIENTS: We evaluated the outcomes of patients who received venoarterial extracorporeal membrane oxygenation rescue therapy for refractory cardiovascular failure during bacterial septic shock. Results are expressed as medians (range). MEASUREMENTS AND MAIN RESULTS: From January 2008 to September 2011, 14 patients, 45 years old (28-66), seven males, none with a history of left ventricular dysfunction, received venoarterial extracorporeal membrane oxygenation for septic shock refractory to conventional treatment, 24 hours (3-108) after shock onset. All exhibited severe myocardial dysfunction at extracorporeal membrane oxygenation implantation. Left ventricular ejection fraction was 16% (10% to 30%), cardiac index was 1.3 L/min/m (0.7-2.2 ) and systemic resistance vascular index was 3162 (2047-7685). All were receiving high-dose catecholamines and had signs of multiple organ failure: pH 7.16 (6.68-7.39), blood lactate 9 (2-17) mmol/L, PaO2/FIO2 87 (28-364), Simplified Acute Physiology Score III 84 (75-106) and Sepsis-Related Organ Failure Assessment score 18 (8-21). Twelve patients (86%) could be weaned off venoarterial extracorporeal membrane oxygenation after 5.5 days (2-12) days of support and 10 patients (71%) were discharged to home and were alive after a median follow-up of 13 months (3-43). All 10 survivors had normal left ventricular ejection fraction and reported good health-related quality of life at long-term follow-up. CONCLUSIONS: Venoarterial extracorporeal membrane oxygenation rescued more than 70% of the patients who developed refractory cardiovascular dysfunction during severe bacterial septic shock. Survivors reported good long-term quality of life. Venoarterial extracorporeal membrane oxygenation might represent a valuable therapeutic option for adults in severe septic shock with refractory cardiac and hemodynamic failure.

[Circulatory support in cardiology]. / Assistance circulatoire en cardiologie.

Mechanical cardiac assist had progressively changed. Emergency depends of INTERMACS classification. The clinical evolution of patients under cardiac assist determines patient follow up: long duration mechanical support (and not "destination therapy"), recovery and weaning or planned heart transplantation. In case of emergency, extracorporeal membrane oxygenation allowed to stabilize patients and oriented them to one of these options.

[Analysis of 2000 heart transplant, procedures at la Pitié Hospital]. / Réflexions sur 2 000 transplantations cardiaques, expérience de La Pitié.

Since the first procedure carried out at La Pitié Hospital, on 27 April 1968, we have performed 1918 heart transplants. We analyzed outcomes in four successive periods: initial experience from 1968 to 1981 (53 patients), using early immunosuppressive regimens; an expansion phase (839 patients) from 1982 to 1992, with the introduction of cyclosporine; a stabilisation phase (522 patients) from 1993 to 2003; and the most recent phase (504 patients) from 2004 to 2010. We focused particularly on the most recent period. National super-emergency "rules were created, and grafts from older," "borderline" donors were used. Hyperimmune recipients started to be grafted, and ECMO was frequently used during the preoperative and postoperative periods. Due to limited organ availability, we have gradually placed more and more patients on mechanical cardiac support as a bridge to transplantation. Their quality of life is improved.

Outcomes, long-term quality of life, and psychologic assessment of fulminant myocarditis patients rescued by mechanical circulatory support.

OBJECTIVE: Myocarditis is a rare disease that may progress rapidly to refractory cardiogenic shock and death. In such situations, emergent initiation of mechanical circulatory assistance is the only therapeutic option to rescue these dying patients. This study was designed to evaluate the outcomes, health-related quality of life and frequencies of anxiety, depression and posttraumatic stress disorder symptoms in fulminant myocarditis patients rescued by mechanical circulatory assistance, since these major components of outcome evaluation after serious illnesses have not yet been assessed in this setting. DESIGN: A retrospective, single-center, observational study and a cross-sectional survey to assess health-related quality of life by the Short Form-36 questionnaire and frequencies of anxiety, depression and posttraumatic stress disorder symptoms by the Hospital Anxiety and Depression Scale and the Impact of Event Scale, respectively. SETTING: An 18-bed tertiary intensive care unit in a university hospital. PATIENTS: We analyzed the short- and long-term outcomes of 41 patients hospitalized at our institution between 2003 and 2009 and who received either a Thoratec BiVAD (Thoratec, Pleasanton, CA) (n = 6) or extracorporeal membrane oxygenation (n = 35) to combat refractory cardiogenic shock due to fulminant myocarditis. MEASUREMENTS AND MAIN RESULTS: Intensive care unit survival was 68%, and four (10%) patients underwent heart transplantation. Independent predictors of in-intensive care unit death were Simplified Acute Physiology Score II ≥56 (odds ratio = 10.23) and troponin Ic ≥12 µg/L (odds ratio = 7.49) at admission. Complete follow-up (median, 525 days) was available for 26 of 28 survivors. Compared to age- and sex-matched controls, Short Form-36 evaluation of health-related quality of life revealed satisfactory mental health and vitality but persistent physical and psychosocial-related difficulties. Lastly, anxiety, depression, and/or posttraumatic stress disorder symptoms were reported by 38%, 27% and 27% of the patients, respectively. CONCLUSIONS: Mechanical circulatory assistance rescued 68% of patients with refractory circulatory failure due to fulminant myocarditis. Greater disease severity and higher troponin Ic levels at extracorporeal membrane oxygenation initiation predicted poorer prognosis. Because up to one-third of the patients reported anxiety, depression, and/or posttraumatic stress disorder symptoms, strategies aimed at attenuating their emotional and psychologic distress might significantly improve their long-lasting well-being.

Outcomes and long-term quality-of-life of patients supported by extracorporeal membrane oxygenation for refractory cardiogenic shock.

OBJECTIVE: To assess the outcomes and long-term quality-of-life of patients supported by extracorporeal membrane oxygenation (ECMO) for refractory cardiogenic shock. DESIGN, SETTING, AND PATIENTS: Refractory cardiogenic shock is almost always lethal without emergency circulatory support, e.g., ECMO. ECMO-associated morbidity and mortality plead for identification of early predictors of its failure, and detailed analyses of short- and long-term outcomes to refine patient selection and improve results. Outcomes of 81 patients given ECMO support for medical (n = 55), postcardiotomy (n = 16), or posttransplantation (n = 10) cardiogenic shock were evaluated. MEASUREMENTS AND MAIN RESULTS: Thirty-four (42%) patients survived to hospital discharge; 57% suffered > or = 1 major ECMO-related complications. Independent predictors of intensive care unit death were: device insertion under cardiac massage (odds ratio [OR] = 20.68), 24 hr urine output < 500 mL (OR = 6.52), prothrombin activity < 50% (OR = 3.93), and female sex (OR = 3.89); myocarditides were associated with better outcomes (OR = .13). Sequelae and health-related quality-of-life were evaluated for 28 long-term survivors (median follow-up, 11 months), whose mean Short-Form 36 scores were significantly lower than matched healthy controls for physical role, general health, and social functioning, but higher than those reported for patients on chronic hemodialysis, with advanced heart failure, or after recovery from acute respiratory distress syndrome. CONCLUSIONS: ECMO support can rescue 40% of otherwise fatal cardiogenic shock patients but its initiation under cardiac massage or after renal or hepatic failure carried higher risks of intensive care unit death, while fulminant myocarditis had a better prognosis. Despite satisfactory mental health and vitality, long-term survivors' persistent physical and social problems might benefit from tailored medical or psychosocial interventions.

Predictive value of liver damage for severe early complications and survival after heart transplantation: A retrospective analysis.

BACKGROUND: Hepatic dysfunction is often associated with advanced heart failure. Its impact on complications following heart transplantation is not well known. We studied the influence of preoperative hepatic dysfunction on the results of heart transplantation with a specific priority access for critical patients. METHODS: Consecutive heart transplantation patients were retrospectively analyzed at listing to detect predictive factors for early complications and survival following heart transplantation. RESULTS: Among heart transplant candidates (n=384), median age was 52 years, dilated and ischemic cardiopathies were present in 44% and 32%, respectively. Clinical ascites was present in 15.6% and median MELD score was 13. A temporary circulatory support and a national priority access were necessary in 14.8% and 35% respectively. Whereas 12% of the global cohort died on the waiting list, 321 patients were transplanted, 34.2% suffered from severe early complications, 26.3% needed extracorporeal membrane oxygenation in postoperative period, 27.7% died before 3 months with a 5-year survival rate of 56%. At listing, clinical ascites, and creatinine were independently associated with specific early complications i.e. primary graft dysfunction and septic shock respectively. Bilirubin level was also an independent marker of other early complications. Finally, need for postoperative circulatory support and postoperative 90-day mortality were strongly and exclusively associated with clinical ascites and creatinine at listing. In a subgroup analysis, we predicted more accurately the postoperative survival at 3 months by combining MELD score and ascites. CONCLUSION: At listing, hepatic and renal dysfunctions are independent risk factors that could predict severe early complications and mortality following heart transplantation in the most severe patients.

Survey: retrospective survey of monitoring/safety devices and incidents of cardiopulmonary bypass for cardiac surgery in France.

Several surveys showed that cardiopulmonary bypass (CPB) is associated with incidents that negatively affect outcome and suggested that improved monitoring and safety could be associated with a decreased rate of incidents. In 2004, the French "Haute Autorité de Santé" (an independent French government advisory agency) and the French College of Perfusion issued recommendations concerning safety and monitoring devices for CPB. The aims of this study were to investigate the difference between the recommendations and the clinical practice of CPB shortly after publication of the recommendations and compare the 2005 situation with the results of a previous survey performed in France and to investigate the rate of perfusion incidents and their outcome. A 62-item questionnaire was sent in January 2006 to all 66 centers performing cardiac surgery and CPB in France. The survey investigated the use of safety and monitoring devices as well as perfusion incidents for 2005. Fifty-seven centers (response rate, 86%) returned the questionnaire, totaling 34,496 CPB procedures. There was a wide difference between the recommendations and the reported use of safety and monitoring devices with no clinically relevant change from the previous French survey concerning 2001. An incident was reported for every 198 CPB procedures with death at a frequency of 1:4864 and permanent sequelae of 1:11,349, respectively (a permanent injury or death in 1:3220 procedures). The three most frequent perfusion incidents were adverse effects to protamine (1:1702), dissection at the arterial cannulation site (1:1792), and coagulation of the circuit (1:4864). In conclusion, this survey showed that an important effort must be made in France to implement into clinical practice the recommendations concerning CPB monitoring and safety devices. The analysis of CPB-related incidents suggest that, with the exception of protamine adverse effects, the majority of deaths and severe permanent injuries in this survey could probably be avoided by improved use of the monitoring and safety devices.

Laparoscopic sleeve gastrectomy in the South Pacific. Retrospective evaluation of 510 patients in a single institution.

INTRODUCTION: The South Pacific has a high prevalence of obesity and super-obesity. We reviewed our experience with laparoscopic sleeve gastrectomy (LSG) to evaluate its efficacy and safety. METHODS: A retrospective review of a prospectively collected database of LSGs carried out by one surgeon in one center. The percentage of excess weight loss and the rate of resolution or improvement of comorbidities reflected efficacy, and major complications or mortalities reflected safety. RESULTS: From January 2008 to February 2013, we performed 510 surgeries and included 494 consecutive patients (367 females) (45.5 ± 11.2 years) in our study. LSG was the primary procedure in 384 patients, 6 patients had redo bariatric surgery after failure of initial LSG, 57 patients had a history of gastric banding with insufficient weight loss or band-related complications, and 46 super-obese patients had an intragastric balloon placed before LSG. Average starting body mass index was 47.8 kg m(-2). Mean percent excess weight loss was 64.3% at 1 year; 67.3% at 2 years and 66.4% at 3 years. The percentages of resolved comorbidities were as follows: hypertension: 48.3%, type 2 diabetes mellitus: 72.5%, dyslipidemia: 61.0%, and obstructive sleep apnea: 77.8%. The mortality rate was 1/494. The postoperative morbidity included gastric fistula in 3.0%, hemorrhaging in 2.4%, and postoperative gastroesophageal reflux in 9.4%. CONCLUSIONS: In the South Pacific, LSG is a safe and effective means of treating morbid obesity with sustained weight loss and resolution of comorbid medical conditions.

Extracorporeal life support as a bridge to bridge: a strategy to optimize ventricular assist device results.

OBJECTIVES: Extracorporeal life support (ECLS) devices provide temporary mechanical circulatory assistance and are usually implanted under emergency conditions in critical patients. If weaning off ECLS is not possible, heart transplantation or implantation of long-term mechanical circulatory support (LTMCS) is required. The purpose of our study was to evaluate the bridge-to-bridge (BTB) concept. METHODS: Between 1 January 2004 and 1 August 2010, 97 patients were assisted by LTMCS. The implantation was the first-line intervention in 48 patients (the bridge group), and was performed after a period of ECLS support in 49 others (the BTB group). RESULTS: The long-term survival rate was 51.6%, with a mean follow-up of 30.7 months, and there were no differences for biological parameters between the two groups. Patients in the BTB group whose condition was initially more severe, improved under ECLS support, and those in whom biological parameters did not revert to normal died after LTMCS. Risk factors for mortality in the BTB group were total bilirubin and lactate before LTMCS, and alkaline phosphatase before ECLS support. CONCLUSIONS: The BTB concept allows the implementation of LTMCS in severe patients, for whom it was not originally envisaged, with the same long-term survival as in first-line settings. ECLS in the evolution of patients is predictive of survival after LTMCS.

Utilisation and safety of low molecular weight heparins: prospective observational study in medical inpatients.

AIMS: Low molecular weight heparins (LMWHs) are widely used as curative or preventive treatments of thromboembolic diseases. The aim of our study was to: investigate the pattern of prescription of LMWHs in different departments of French teaching hospitals; andestimate the incidence of adverse drug reactions (ADRs) induced by LMWHs and associated risk factors for the occurrence of bleeding events. METHODS: This prospective study was performed in two teaching hospitals in Toulouse (south-western France) in March 1999 in different medical wards. All patients receiving a prescription for a LMWH were included in the survey. All data were prospectively recorded in each ward. RESULTS: A total of 334 patients were included. Sex ratio (male/female) was 1.25 and mean age was 72.5 +/- 16.3 years (extremes:18-101). 450 prescriptions for LMWHs were collected (1.34 prescription per patient) and involved mainly enoxaparin (61%), which was more frequently used than tinzaparin in patients over 75 years old (71.7 vs 28.3%; p < 0.0001). Ninety-nine patients received a LMWH for curative treatment (corresponding to 127 prescriptions of which 99 were for enoxaparin and 28 were for tinzaparin [p < 0.0001]). Indications included therapy for deep venous thrombosis, pulmonary embolism, acute coronary syndrome, unstable angina pectoris, non-Q-wave myocardial infarction. Serious renal insufficiency was significantly more frequent in patients from the geriatrics department (p < 0.00001). Enoxaparin was prescribed more frequently in patients with serious or moderate renal insufficiency than tinzaparin (72 vs 61%, p < 0.05). The incidence of LMWHs-induced ADRs was 10.5% occurring in 22 cases during preventive treatment of deep venous thrombosis and in 13 cases during curative therapy. ADRs were classified as 'serious' in 11 cases (31.4%). Reported ADRs were bleeding events (n = 15), thrombocytosis (n = 13), thrombopenia (n = 4) and hepatic cytolysis (n = 1). The mean delay for the occurrence of bleeding effects was 8.0 +/- 9.1 days (range 1-40). Multivariate analysis of the influence of several criteria on the occurrence of haemorrhagic effects showed that the decrease of creatinine clearance (10 ml/min) was associated with an increased haemorrhagic risk (relative risk [RR] = 1.34, 95% CI 1.12-1.65; p < 0.05). Moreover, the risk of adverse bleeding effects increased for patients with a creatinine clearance <20 ml/min (RR = 2.8; 95% CI 1.00-7.8). CONCLUSION: Our data firstly show a different pattern of LMWHs prescription in different clinical wards. Secondly, the risk of bleeding ADRs in patients treated by LMWHs increases significantly with renal function impairment for the two LMWH preparations studied. More pharmacoepidemiological studies are necessary in patients with several risk factors, particularly in elderly people who often have renal impairment, in order to determine the optimal pattern use of each LMWH.

Circulatory support for fulminant myocarditis: consideration for implantation, weaning and explantation.

OBJECTIVE: Fulminant myocarditis (FM) is an uncommon but life-threatening condition for which a mechanical circulatory support (MCS) device can be life-saving. However, device selection, weaning and explantation procedures remain poorly defined. METHODS: Four patients were bridged to recovery using the Thoratec biventricular support device. All four were in a state of cardiogenic shock with rapid deterioration of their clinical status despite increasing doses of inotropes. Three patients required mechanical respiratory support, three were anuric and one was dialyzed. Echocardiography showed a mean ejection fraction of 12+/-8%. RESULTS: Each Thoratec implantation was performed on cardiopulmonary bypass with a beating heart. Three patients underwent biventricular cannulation. The fourth patient underwent left ventricular and right atrial cannulation. All patients manifested evidence of moderate to severe end organ dysfunction after device implantation. However, by explantation, end organ function had recovered in all patients. After a mean duration of 17+/-10 days, all the patients showed evidence of myocardial recovery. Recovery was confirmed on echocardiography which showed opening of the aortic valve and contraction of both ventricles. The weaning process was performed in 2-5 days by setting the device in a fixed mode and increasing the rate. Device explantation was uneventful in the four patients. At the 6 months echocardiography follow-up, all had normal systolic function. CONCLUSION: In patients with FM, biventricular support allows full circulatory support and unloads both ventricles until recovery occurs. In this set of patients, weaning and removal procedures are straight-forward. These results suggest an aggressive stance toward implantation of MCS in patients with FM.