Early hyperoxia and 28-day mortality in patients on venoarterial ECMO support for refractory cardiogenic shock: a bicenter retrospective propensity score-weighted analysis.

BACKGROUND: The mortality rate for a patient with a refractory cardiogenic shock on venoarterial (VA) extracorporeal membrane oxygenation (ECMO) remains high, and hyperoxia might worsen this prognosis. The objective of the present study was to evaluate the association between hyperoxia and 28-day mortality in this setting. METHODS: We conducted a retrospective bicenter study in two French academic centers. The study population comprised adult patients admitted for refractory cardiogenic shock. The following arterial partial pressure of oxygen (PaO2) variables were recorded for 48 h following admission: the absolute peak PaO2 (the single highest value measured during the 48 h), the mean daily peak PaO2 (the mean of each day's peak values), the overall mean PaO2 (the mean of all values over 48 h), and the severity of hyperoxia (mild: PaO2 < 200 mmHg, moderate: PaO2 = 200-299 mmHg, severe: PaO2 ≥ 300 mmHg). The main outcome was the 28-day all-cause mortality. Inverse probability weighting (IPW) derived from propensity scores was used to reduce imbalances in baseline characteristics. RESULTS: From January 2013 to January 2020, 430 patients were included and assessed. The 28-day mortality rate was 43%. The mean daily peak, absolute peak, and overall mean PaO2 values were significantly higher in non-survivors than in survivors. In a multivariate logistic regression analysis, the mean daily peak PaO2, absolute peak PaO2, and overall mean PaO2 were independent predictors of 28-day mortality (adjusted odds ratio [95% confidence interval per 10 mmHg increment: 2.65 [1.79-6.07], 2.36 [1.67-4.82], and 2.85 [1.12-7.37], respectively). After IPW, high level of oxygen remained significantly associated with 28-day mortality (OR = 1.41 [1.01-2.08]; P = 0.041). CONCLUSIONS: High oxygen levels were associated with 28-day mortality in patients on VA-ECMO support for refractory cardiogenic shock. Our results confirm the need for large randomized controlled trials on this topic.

Central venous-to-arterial PCO2 difference, arteriovenous oxygen content and outcome after adult cardiac surgery with cardiopulmonary bypass: A prospective observational study.

BACKGROUND: Rapid identification and treatment of tissue hypoxia reaching anaerobiosis (dysoxia) may reduce organ failure and the occurrence of major postoperative complications (MPC) after cardiac surgery. The predictive ability of PCO2-based dysoxia biomarkers, central venous-to-arterial PCO2 difference (ΔPCO2) and ΔPCO2 to arteriovenous oxygen content difference ratio, is poorly studied in this setting. OBJECTIVES: We evaluated the ability of PCO2-based tissue dysoxia biomarkers, blood lactate concentration and central venous oxygen saturation measured 2 h after admission to the ICU as predictors of MPC. DESIGN: A prospective, observational cohort study. SETTING: Single-centre, academic hospital cardiovascular ICU. PATIENTS: We included adult patients undergoing cardiac surgery with cardiopulmonary bypass and measured dysoxia biomarkers at ICU admission, and after 2, 6 and 24 h. MAIN OUTCOME MEASURES: The primary endpoint was MPC, a composite of cardiac and noncardiac MPC evaluated in the 48 h following surgery. After univariate analysis of MPC covariates including dysoxia biomarkers measured at 2 h, multivariate logistic regression analyses were performed to identify the association of these biomarkers with MPC for confounders. Areas under the receiver operating characteristic curves were determined for biomarkers which remained independently associated with MPC. RESULTS: MPC occurred in 56.5% of the 308 patients analysed. ΔPCO2, blood lactate concentration and central venous oxygen saturation measured at 2 h, but not ΔPCO2 to arteriovenous oxygen content difference ratio, were significantly associated with MPC. However, only ΔPCO2 was independently associated with MPC after multivariate analysis. The areas under the receiver operating characteristic curves of ΔPCO2 measured at 2 h for MPC prediction was 0.64 (95% CI 0.57 to 0.70, P < 0.001). CONCLUSION: After cardiac surgery with cardiopulmonary bypass, ΔPCO2 measured 2 h after ICU admission was the only dysoxia biomarker independently associated with MPC, but with limited performance. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03107572.

[Balancing drug regulation and health democracy: The role of patient and healthcare professional advisors at the ANSM]. / Concilier régulation du médicament et démocratie sanitaire : rôle des conseillers patient ou professionnel de santé à l'ANSM.

The French National Agency for Health Products (ANSM) is a regulatory and public health agency. Its regulatory, health policing and public health protection activities require a perfect fit with the field and the various people involved in the use of health products. Since 2019, the ANSM has adapted its organisation, procedures and processes to encourage and improve interaction with its stakeholders, as part of its policy of openness towards civil society. To accompany this ambitious change and to support its staff, the Agency has recruited advisors corresponding to the main users of health products: prescribers (doctor's hospital and outpatient), pharmacists and patients. Working as a group or individually, they provide a "lived" user perspective on health products at each stage of the evaluation process. They may be involved in the assessment of dossiers, signals or applications received by the Agency, in the internal validation of reports or in discussions with stakeholders. They are particularly involved when the analysis requires expertise that goes beyond the technical, scientific or regulatory aspects. They may also work with ANSM staff to explain certain processes and difficulties in the field. Advisors help to ensure that regulatory and/or scientific expertise is clear and consistent with user experience. In addition to their scientific and therapeutic aspects, medicines are also economic, social and political issues. Their regulation is therefore particularly affected by the need for health democracy. This requires the active participation of health professionals, patients and, more broadly, civil society in the decision-making process. Civil society is a space occupied by a wide range of actors who exert pressure from different ideological positions to influence the regulation of health products. In this context, taking into account a plurality of viewpoints in the regulation of health products is necessary and complex, but its operation can be facilitated by the collective efforts of the actors and the adaptation of organisations, such as the integration of advisors.

Neopulmonary Venous Confluence for Heart Transplantation With Giant Left Atrium.

Heart transplantation in a recipient with giant left atrium is rare. To correct the mismatch between recipient and donor at the level of the left atrium, plication of the left atrium has been proposed. We report a case in which plication was not feasible owing to significant calcification of the left atrial wall and tight pericardial adhesions resulting from two previous sternotomies. Creating a pulmonary venous confluence allows orthotopic heart transplantation with any size of left atrium and conformation of pulmonary veins in cases of significant calcification or redo sternotomy.

First case of postaneurysmal prosthetic vascular infection due to a nonsuperantigenic Yersinia pseudotuberculosis strain.

Among Yersinia spp., Y. enterocolitica is the species most frequently isolated from infected aneurysms. This report describes the first case of postaneurysmal prosthetic vascular infection due to a superantigen-negative Yersinia pseudotuberculosis strain, showing a potential affinity of this species for endovascular tissue.

TEVAR in patients with late complications of aortic coarctation repair.

PURPOSE: To review the use of thoracic endovascular aortic repair (TEVAR) for late pseudoaneurysm formation after surgical repair of aortic coarctation. METHODS: From May 2001 to May 2005, 8 patients (5 men; mean age 47.6 years, range 18-73) with a history of aortic coarctation repairs 17 to 40 years prior were referred to our institution for an anastomotic thoracic pseudoaneurysm. TEVAR was performed successfully in 7 patients; 1 died of suspected aneurysm rupture before the scheduled procedure. A carotid-subclavian bypass was performed in 3 patients. RESULTS: All the procedures were immediately successful. No type I endoleaks were seen on the final control angiogram, but 2 of the patients with carotid-subclavian bypasses required additional left subclavian artery embolization due to type II endoleak. One of these patients died before embolotherapy on the 5th postoperative day from presumed aneurysm rupture (14% 30-day mortality rate). Over a follow-up period ranging from 15 to 72 months (mean 37), all the false aneurysms have remained thrombosed and the mean diameter has decreased from 44 to 23 mm. No endograft-related complications have occurred, and no further interventions have so far been necessary. CONCLUSION: TEVAR is a feasible alternative treatment for patients who have already undergone surgical repair of aortic coarctation. Technical issues regarding the endovascular strategy should be discussed with a multidisciplinary team to define the correct interventional plan.

Conservative surgical treatment for active infective tricuspid valve endocarditis according to the "clover technique".

AIMS: This prospective study was undertaken to analyze the outcomes of conservative surgery with the "clover technique" for active infective tricuspid valve endocarditis. METHODS: Five consecutive patients underwent surgery for active infective tricuspid valve endocarditis. The mean age was 36.6 years. Four of the patients were men. In all patients, the tricuspid valve had become mutilated and infected. One patient had associated mitral endocarditis, and one had aortic endocarditis. Staphylococcus aureus was the most common bacterial species. Conservative surgery was indicated in all patients with infection limited to the leaflets and/or subvalvular apparatus of the tricuspid valve. Total resection of infected tissues was achieved in all cases. The tricuspid valve was then reconstructed according to the clover technique. A tricuspid annular ring was used in 2 patients. RESULTS: All 5 patients survived surgery. Intraoperative transesophageal and predischarge transthoracic echocardiographic evaluations showed good results in all patients. The mean follow-up time was 26.4 +/- 12.5 months. No recurrent bacterial tricuspid endocarditis occurred during follow-up. All patients were in New York Heart Association functional class I. A transthoracic echocardiography evaluation at the latest control examination showed trivial leakage (3 patients) or no residual regurgitation (2 patients); no transvalvular gradient was found in any of the patients. No tricuspid valve calcification has been detected to date. Cardiac magnetic resonance imaging analyses showed no postoperative void flow and confirmed the preservation of right ventricular function and thus the reliability of this technique. CONCLUSIONS: This novel technique is indicated for tricuspid valve endocarditis and should be considered as an adequate approach in cases of uncontrollable infection involving the tricuspid valve that is responsible for extended valve destruction.

Acquired von Willebrand syndrome in aortic stenosis.

BACKGROUND: Aortic-valve stenosis can be complicated by bleeding that is associated with acquired type 2A von Willebrand syndrome. However, the prevalence and cause of the hemostatic abnormality in aortic stenosis are unknown. METHODS: We enrolled 50 consecutive patients with aortic stenosis, who completed a standardized screening questionnaire to detect a history of bleeding. Forty-two patients with severe aortic stenosis underwent valve replacement. Platelet function under conditions of high shear stress, von Willebrand factor collagen-binding activity and antigen levels, and the multimeric structure of von Willebrand factor were assessed at base line and one day, seven days, and six months postoperatively. RESULTS: Skin or mucosal bleeding occurred in 21 percent of the patients with severe aortic stenosis. Platelet-function abnormalities under conditions of high shear stress, decreased von Willebrand factor collagen-binding activity and the loss of the largest multimers, or a combination of these was present in 67 to 92 percent of patients with severe aortic stenosis and correlated significantly with the severity of valve stenosis. Primary hemostatic abnormalities were completely corrected on the first day after surgery but tended to recur at six months, especially when there was a mismatch between patient and prosthesis (with an effective orifice area of less than 0.8 cm2 per square meter of body-surface area). CONCLUSIONS: Type 2A von Willebrand syndrome is common in patients with severe aortic stenosis. Von Willebrand factor abnormalities are directly related to the severity of aortic stenosis and are improved by valve replacement in the absence of mismatch between patient and prosthesis.

A case of mitral endocarditis due to Campylobacter fetus subsp. fetus.

This report describes a patient presenting mitral native endocarditis due to Campylobacter fetus subsp. fetus, which was revealed by syncope and identified using 16S ribosomal RNA gene sequencing. This gene sequencing method has become the preferred approach to identifying the new emerging pathogens when discrepancies exist between phenotypical tests.

Extracorporeal membrane oxygenation in severe acute respiratory failure in postpartum woman with rheumatic mitral valve disease: benefit, factors furthering the success of this procedure, and review of the literature.

Pregnancy is a common decompensation factor for women with post-rheumatic mitral disease. However, valvular heart diseases causing severe acute respiratory distress are rare. Use of extracorporeal membrane oxygenation (ECMO) early in the event of cardiorespiratory failure after cardiac surgery may be of benefit. Indeed, ECMO cardiopulmonary bypass (CPB) support could help pulmonary recovery if the mitral pathology is involved. A 31-year-old female patient at 30 weeks of amenorrhea was admitted to the obstetrics department with 40 degrees C hyperthermia and New York Heart Association (NYHA) class 4 dyspnea. The patient's medical history included a post-rheumatic mitral stenosis. Blood gases showed severe hypoxemia associated with hypocapnia. The patient needed to be rapidly intubated and was placed on ventilatory support because of acute respiratory failure. Transesophageal echocardiography showed a severe mitral stenosis, mild mitral insufficiency, and diminished left ventricular function, hypokinetic, dilated right ventricle, and a severe tricuspid regurgitation. An urgent cesarean section was performed. Because of the persistent hemodynamic instability, a mitral valvular replacement and tricuspid valve annuloplasty were performed. In view of the preoperative acute respiratory distress, we decided, at the beginning of the operation, to carry on circulatory support with oxygenation through an ECMO-type CPB at the end of the operation. This decision was totally justified by the unfeasible CPB weaning off. ECMO use led to an efficient hemodynamic state without inotropic drug support. The surgical post-operative course was uneventful. Early use of cardiorespiratory support with veno-arterial ECMO allows pulmonary and right heart recovery after cardiac surgery, thus avoiding the use of inotropic drugs and complex ventilatory support.