Prevention of post-operative delirium using an overnight infusion of dexmedetomidine in patients undergoing cardiac surgery: a pragmatic, randomized, double-blind, placebo-controlled trial.

BACKGROUND: After cardiac surgery, post-operative delirium (PoD) is acknowledged to have a significant negative impact on patient outcome. To date, there is no valuable and specific treatment for PoD. Critically ill patients often suffer from poor sleep condition. There is an association between delirium and sleep quality after cardiac surgery. This study aimed to establish whether promoting sleep using an overnight infusion of dexmedetomidine reduces the incidence of delirium after cardiac surgery. METHODS: Randomized, pragmatic, multicentre, double-blind, placebo controlled trial from January 2019 to July 2021. All adult patients aged 65 years or older requiring elective cardiac surgery were randomly assigned 1:1 either to the dexmedetomidine group or the placebo group on the day of surgery. Dexmedetomidine or matched placebo infusion was started the night after surgery from 8 pm to 8 am and administered every night while the patient remained in ICU, or for a maximum of 7 days. Primary outcome was the occurrence of postoperative delirium (PoD) within the 7 days after surgery. RESULTS: A total of 348 patients provided informed consent, of whom 333 were randomized: 331 patients underwent surgery and were analysed (165 assigned to dexmedetomidine and 166 assigned to placebo). The incidence of PoD was not significantly different between the two groups (12.6% vs. 12.4%, p = 0.97). Patients treated with dexmedetomidine had significantly more hypotensive events (7.3% vs 0.6%; p < 0.01). At 3 months, functional outcomes (Short-form 36, Cognitive failure questionnaire, PCL-5) were comparable between the two groups. CONCLUSION: In patients recovering from an elective cardiac surgery, an overnight infusion of dexmedetomidine did not decrease postoperative delirium. Trial registration This trial was registered on ClinicalTrials.gov (number: NCT03477344; date: 26th March 2018).

Transfemoral versus trans-subclavian access in transcatheter aortic valve implantation using self-expandable valve: A propensity-matched comparison.

BACKGROUND: Transcatheter aortic valve implantation is unfeasible for 10-15% of patients using the conventional transfemoral approach. Other alternative approaches, such as the subclavian approach, have emerged, with no clear recommendation indicating the superiority of one technique over another. AIM: To compare the 1-month mortality and postprocedural outcomes of patients undergoing transcatheter aortic valve implantation using a self-expandable valve via transfemoral and subclavian access. METHODS: This was a retrospective single-centre study including 1496 patients who underwent transcatheter aortic valve implantation between January 2016 and December 2020 at Clermont-Ferrand University Hospital, France. Propensity score matching was used to compare transfemoral and subclavian access. RESULTS: After building two propensity score-matched groups of 221 patients each with either access route (total n=442), baseline characteristics were similar. The procedure duration was significantly longer in the subclavian access group (53 [45-64] versus 60 [51-72] minutes; P<0.001), but with a lower amount of contrast agent (138 [118-165] versus 123 [105-150] mL; P<0.001), fluoroscopy time (11.2 [9-14] versus 9.9 [7-12] minutes; P<0.001) and radiation dose (397 [264-620] versus 321 [217-485] mGy; P<0.001). No significant difference was observed concerning 1-month mortality (odds ratio 1.62, 95% confidence interval 0.52-5.03; P=0.39) or periprocedural complications. Follow-up at 1 year confirmed no difference in longer-term mortality (hazard ratio 0.78, 95% confidence interval 0.52-5.03; P=0.43). CONCLUSIONS: The subclavian approach provides similar results to the transfemoral approach in terms of mortality, efficacy and safety; it is a reasonable and effective alternative when the reference transfemoral approach is impossible or seems complex.

Inhaled nitric oxide before induction of anesthesia in patients with pulmonary hypertension.

Background: The aim of this study was to examine the action of inhaled nitric oxide in the patients with pulmonary hypertension administered with a face mask before anesthesia induction. Methods: Ten adult patients scheduled for heart surgery with sternotomy were included in this prospective, interventional, single centre study. The inclusion criteria were patients scheduled for heart surgery with sternotomy with cardiopulmonary bypass (CPB), aged >18 years which presents a pulmonary hypertension (PH) (class 2 or 3 according to the Dana Point classification) with systolic pulmonary arterial pressure (PAPS) >40 mmHg diagnosed by preoperative right cardiac catheterization or by transthoracic echocardiography. The exclusion criteria were: heart transplant, PH of type 1, 4, 5, according to the Dana Point classification, methemoglobin reductase deficit, incapacity to understand the protocol and sign the consent. Results: The administration of iNO decrease pulmonary hypertension (P < 0,001 compared to room air; P = 0,01 compared to pure oxygen administration). The iNO administration did not improve arterial blood oxygenation. The hyperoxia, decrease the cardiac index even with right ventricular post charge decrease. The increased blood oxygenation content cause systemic vascular vasoconstriction and decrease the peripheral oxygen extraction showed with VO2 linear increase (P < 0,001). Conclusions: The administration of inhaled nitric oxide with a face mask before anaesthesia induction is safe and effective method to reduce pulmonary hypertension. The oxygen and hyperoxia influences the systemic vascular resistance and peripheral oxygen consumption.

Multicentre, open-label, randomised, controlled clinical trial comparing 2% chlorhexidine-70% isopropanol and 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery: the CLEAN 2 study protocol.

INTRODUCTION: Surgical-site infection (SSI) is the second most frequent cause of healthcare-associated infection worldwide and is associated with increased morbidity, mortality and healthcare costs. Cardiac surgery is clean surgery with low incidence of SSI, ranging from 2% to 5%, but with potentially severe consequences.Perioperative skin antisepsis with an alcohol-based antiseptic solution is recommended to prevent SSI, but the superiority of chlorhexidine (CHG)-alcohol over povidone iodine (PVI)-alcohol, the two most common alcohol-based antiseptic solutions used worldwide, is controversial. We aim to evaluate whether 2% CHG-70% isopropanol is more effective than 5% PVI-69% ethanol in reducing the incidence of reoperation after cardiac surgery. METHODS AND ANALYSIS: The CLEAN 2 study is a multicentre, open-label, randomised, controlled clinical trial of 4100 patients undergoing cardiac surgery. Patients will be randomised in 1:1 ratio to receive either 2% CHG-70% isopropanol or 5% PVI-69% ethanol for perioperative skin preparation. The primary endpoint is the proportion of patients undergoing any re-sternotomy between day 0 and day 90 after initial surgery and/or any reoperation on saphenous vein/radial artery surgical site between day 0 and day 30 after initial surgery. Data will be analysed on the intention-to-treat principle. ETHICS AND DISSEMINATION: This protocol has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: EudraCT 2017-005169-33 and NCT03560193.

Transcultural adaptation and French validation of the Pain Sensitivity Questionnaire.

PURPOSE: To validate a French translation of the Pain Sensitivity Questionnaire (PSQ), which is a valuable tool to predict an individual's natural disposition to feel pain that could be used after surgery. METHODS: We studied content validity, internal consistency, convergent validity (anxiety, depression and catastrophism) and test-retest reliability of the French version of the PSQ (PSQ-F) in 146 patients either before scheduled surgery or during pregnancy; then, convergent and concurrent validity in 85 healthy volunteers submitted to nociceptive tests. RESULTS: Internal consistency of the PSQ-F was found to be excellent, with Cronbach's α at 0.866, 0.886, and 0.927, respectively for its "minor", "moderate" and "total" scores. Test-retest reliability was significant, with intraclass correlation coefficients at 0.629, 0.629, and 0.635, respectively for the above- mentioned scores. These three scores correlated with anxiety, depression and catastrophizing scores in patients, but not in healthy volunteers, possibly because of low and few variant psychometric scores in this group. They were inversely correlated to the temperature needed to evoke heat pain rated 6 out of 10, but not to the mechanical pain threshold (electronic von Frey), nor to the heat pain threshold. Finally, they directly correlated to the pain induced by the cold pressor test (minor and total scores only). DISCUSSION: This validated version can now be used by French-speaking researchers and physicians. TRIAL REGISTRATION: www.ClinicalTrials.gov (NCT03113903); 14 April, 2017.

RéSUMé: OBJECTIF: Valider une version en langue française du Pain Sensitivity Questionnaire (PSQ), qui permet d'identifier la sensibilité naturelle d'un individu à la douleur, ce qui pourrait être applicable après une chirurgie. MéTHODE: Nous avons étudié la validité de structure interne, la validité convergente (anxiété, dépression et catastrophisme) et la reproductibilité par test-retest de la version française du PSQ (PSQ-F) chez 146 patients en situation préopératoire ou en cours de grossesse, puis la validité convergente et de structure contre critère externe chez 85 sujets volontaires sains soumis à des tests nociceptifs. RéSULTATS: La consistance interne du PSQ-F était excellente avec des α de Cronbach égaux à 0,866, 0,886 et 0,927, respectivement pour ses scores « mineur ¼, « modéré ¼ et « total ¼. La reproductibilité était satisfaisante, avec des coefficients de corrélation intra-classe, respectivement à 0,629, 0,629 et 0,635. Ces trois scores étaient corrélés à l'anxiété, la dépression et le catastrophisme, mais pas chez les volontaires sains qui avaient des scores psychométriques bas et peu variables. Ils étaient anti-corrélés au seuil de nociception thermique chaud en épreuve supra-liminale, mais pas au seuil de nociception mécanique ponctuelle, ni au seuil de nociception thermique chaud en épreuve liminale. Enfin, les scores « mineur ¼ et « total ¼ étaient corrélés à la douleur moyenne ressentie à l'immersion du pied en eau froide. CONCLUSION: Cette version validée peut être utilisée par les chercheurs et cliniciens francophones. ENREGISTREMENT DE L'éTUDE: www.ClinicalTrials.gov (NCT03113903); le 14 avril 2017.

Transaortic Left Ventricular Unloading in VA-ECMO: The Transsubclavian Route.

Left ventricular unloading during extracorporeal life support aims to minimize potential side effects of increased left ventricular afterload. A transaortic catheter vent implanted through a subclavian approach was used in 2 patients. Patient 1 was a 48-year-old man with a recent history of ST-elevation myocardial infarction who developed refractory cardiogenic shock due to severe biventricular dysfunction. Patient 2 was a 56-year-old man admitted for severe flu. The unloading procedure was successful in both patients, with bridge to heart transplantation in the first case and bridge to recovery in the other.

Indications and perioperative outcomes of extracorporeal life support in clermont-ferrand.

OBJECTIVES: To report the epidemiological profile of the patients who underwent extracorporeal life support (ECLS) and then analyze the indications and outcomes of this procedure. METHODS: It consisted of a retrospective and descriptive study based on the database from the department of cardiovascular surgery. SETTING: University hospital clinic. PATIENTS: One hundred and sixty-one patients have participated in the study. Included were all patients who presented with left-sided heart or biventricular failure. Those who were suffering from either isolate respiratory failure or isolate right ventricle failure were excluded. INTERVENTIONS: Participants underwent ECLS: central ECLS or peripheral ECLS. RESULTS: : The mean age of the patients was 54 years; there were 73% of male patients and the mean duration of ECLS was 5.3 days. There were two types of ECLS: central (71%) and peripheral (29%). Indications for support were dominated by cardiogenic shock in 69%. Bleeding was the most frequent complication (23.5%). The overall in-hospital mortality of patients who underwent ECLS was 60%. CONCLUSION: The number of ECLS performed increases in proportion to mastery of surgical technique. There is a high rate of mortality and morbidity with ECLS. However, it remains a lifesaving therapy for many clinically urgent situations.

Clinical outcomes of tricuspid valve repair accompanying left-sided heart disease.

AIM: To determine whether the need for additional tricuspid valve repair is an independent risk factor when surgery is required for a left-sided heart disease. METHODS: One hundred and eighty patients (68 ± 12 years, 79 males) underwent tricuspid annuoplasty. Cox proportional-hazards regression model for multivariate analysis was performed for variables found significant in univariate analyses. RESULTS: Tricuspid regurgitation etiology was functional in 154 cases (86%), organic in 16 cases (9%), and mixed in 10 cases (6%), respectively. Postoperative mortality at 30 days was 11.7%. Mean follow-up was 51.7 mo with survival at 5 years of 73.5%. Risk factors for mortality were acute endocarditis [hazard ratio (HR) = 9.22 (95%CI: 2.87-29.62), P < 0.001], ischemic heart disease requiring myocardial revascularization [HR = 2.79 (1.26-6.20), P = 0.012], and aortic valve stenosis [HR = 2.6 (1.15-5.85), P = 0.021]. Significant predictive factors from univariate analyses were double-valve replacement combined with tricuspid annuloplasty [HR = 2.21 (1.11-4.39), P = 0.003] and preoperatively impaired ejection fraction [HR = 1.98 (1.04-3.92), P = 0.044]. However, successful mitral valve repair showed a protective effect [HR = 0.32 (0.10-0.98), P = 0.046]. Additionally, in instances where tricuspid regurgitation required the need for concomitant tricuspid valve repair, mortality predictor scores such as Euroscore 2 could be shortened to a simple Euroscore-tricuspid comprised of only 7 inputs. The explanation may lie in the fact that significant tricuspid regurgitation following left-sided heart disease represents an independent risk factor encompassing several other factors such as pulmonary arterial hypertension and dyspnea. CONCLUSION: Tricuspid annuloplasty should be used more often as a concomitant procedure in the presence of relevant tricuspid regurgitation, although it usually reveals an overly delayed correction of a left-sided heart disease.

The Dose-Dependent Effects of Ketoprofen on Dynamic Pain after Open Heart Surgery.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) can reduce postoperative pain, in both static (i.e., at rest) and dynamic contexts (e.g., during coughing or mobilization), and reduced doses could improve their efficacy/tolerance balance. OBJECTIVES: To test this hypothesis of efficacy after open heart surgery, in which NSAIDs are poorly used, particularly for safety concerns. STUDY DESIGN: Randomized, double-blind trial. SETTING: Single-center, French university hospital. METHODS: Patients. One hundred patients at low risk of postoperative complications undergoing scheduled open heart surgery (97 analyzed). We tested intravenous ketoprofen, at a dose of 0.5 mg/kg-1 every 6 hours during the 48 hours following the end of sedation, after surgery. This standard protocol was compared to a similar one in which half doses were administered, to one with quarter doses, as well as to a placebo group. Analgesia was supplemented by acetaminophen plus self- and nurse-administered intravenous morphine. The primary outcome was the intensity of dynamic pain, assessed over 48 hours on an 11-point numerical rating scale (NRS). RESULTS: Only the full-dose ketoprofen group showed reduced dynamic and static postoperative pain vs. placebo (P < 0.00001 for both). The evolution of dynamic pain suggested a delayed and therefore non-significant effect with the low doses. Ketoprofen did not affect either the postoperative morphine consumption or the tolerance outcomes, such as the volumes of chest tube drainage and the renal function. LIMITATIONS: This pilot trial was undersized to test major tolerance outcomes. CONCLUSIONS: Although we failed to demonstrate any analgesic effects with low doses of ketoprofen, we confirmed the good efficacy/tolerance balance with this propionic NSAID of intermediate COX2-selectivity. Lower doses of NSAIDs, potentiated by a loading dose, should be tested in the future.IRB approval: CPP Sud-Est VI (Clermont-Ferrand, France), on 12/23/2013.Clinical trial registry: EudraCT (2013-003878-27); ClinicalTrials.gov (NCT02180087).Key words: Non-steroidal anti-inflammatory drugs, ketoprofen, cyclooxygenase, pain, postoperative, sternotomy, postoperative rehabilitation, analgesia, side effects.

Valve-sparing aortic root replacement-midterm outcomes and quality of life.

BACKGROUND: This study evaluated the midterm outcomes, the valve related events and quality of life of patients treated by valve-sparing aortic root replacement (VSRR). METHODS: From January 2003 to December 2014, 88 consecutive patients diagnosed with an aortic root aneurysm or ascending aortic aneurysms underwent VSRR surgery. The mean age was 55±14 (range 19-77) years. A total of 84% of the patients were male; 89% were in New York Heart Association functional class I or II, 55% had aortic regurgitation (AR) grade III or IV. Twenty-four patients (27.3%) had bicuspid aortic valve. The mean left ventricular ejection fraction (LVEF) was 61%±9% (range 29-78%). Patients were yearly followed by family doctors and referent cardiologists. Doppler echocardiographic examinations were obtained annually in all patients. The midterm clinical, echocardiographic results and quality of life were analyzed. The mean follow-up was 5.3±3 (range 1-12) years. RESULTS: Hospital mortality was 1%. There were 10 late deaths (11%) including 5 cardiac cases. Two patients (2%) required an aortic valve or graft prosthesis reoperation. Aortic valve endocarditis occurred in two patients. Thromboembolic events were reported in three patients. None of the following morbidity has been observed: structural valve deterioration, nonstructural dysfunction, valve thrombosis, bleeding event. The 5- and 8-year survival were 92% and 88%, respectively. The 8-year survival free from cardiac death was 88%. The mean of EuroQoL visual analogue scale (EQ VAS) and EQ index were respectively 83±15 (range 30-100) and 0.94±0.12 (range 0.5-1). CONCLUSIONS: Eight-year clinical improvement, function of the spared aortic valve and quality of life after valve sparing aortic root surgery appear excellent.

Bilateral sternal infusion of ropivacaine and length of stay in ICU after cardiac surgery with increased respiratory risk: A randomised controlled trial.

BACKGROUND: The continuous bilateral infusion of a local anaesthetic solution around the sternotomy wound (bilateral sternal) is an innovative technique for reducing pain after sternotomy. OBJECTIVE: To assess the effects of the technique on the need for intensive care in cardiac patients at increased risk of respiratory complications. DESIGN: Randomised, observer-blind controlled trial. SETTING: Single centre, French University Hospital. PATIENTS: In total, 120 adults scheduled for open-heart surgery, with one of the following conditions: age more than 75 years, BMI >30 kg m, chronic obstructive pulmonary disease, active smoking habit. INTERVENTION: Either a bilateral sternal infusion of 0.2% ropivacaine (3 ml h through each catheter; 'intervention' group), or standardised care only ('control' group). Analgesia was provided with paracetamol and self-administered intravenous morphine. MAIN OUTCOME MEASURES: The length of time to readiness for discharge from ICU, blindly assessed by a committee of experts. RESULTS: No effect was found between groups for the primary outcome (P = 0.680, intention to treat); the median values were 42.4 and 37.7 h, respectively for the control and intervention groups (P = 0.873). Similar nonsignificant trends were noted for other postoperative delays. Significant effects favouring the intervention were noted for dynamic pain, patient satisfaction, occurrence of nausea and vomiting, occurrence of delirium or mental confusion and occurrence of pulmonary complications. In 12 patients, although no symptoms actually occurred, the total ropivacaine plasma level exceeded the lowest value for which neurological symptoms have been observed in healthy volunteers. CONCLUSION: Because of a small size effect, and despite significant analgesic effects, this strategy failed to reduce the time spent in ICU. TRIAL REGISTRATION: EudraCT (N°: 2012-005225-69); ClinicalTrials.gov (NCT01828788).

The analgesic effects of a bilateral sternal infusion of ropivacaine after cardiac surgery.

BACKGROUND AND OBJECTIVES: The aim of this study was to assess the effects of a continuous postoperative administration of local anesthetic through 2 catheters placed deeply under fascia at the lateral edges of the sternum, close to the emergence of the intercostal nerves. We focused on pain during mobilization, as this aspect is likely to interact with postoperative morbidity. METHODS: Forty adult patients scheduled for open heart surgery with sternotomy were included in this randomized, placebo-controlled, double-blind study. A continuous fixed-rate infusion of 4 mL/hr of 0.2% ropivacaine or normal saline was administered during the first 48 postoperative hrs. All patients received acetaminophen and self-administered morphine. The efficacy outcomes were as follows: pain score during standardized mobilization and at rest; morphine consumption; spirometry and arterial blood gases; postoperative rehabilitation criteria, and patient satisfaction. Total ropivacaine plasma level was monitored throughout the study. RESULTS: Pain scores were lower in the ropivacaine group during mobilization (P = 0.0004) and at rest (P = 0.0006), but the analgesic effects were mostly apparent during the second day after surgery, with a 41% overall reduction in movement-evoked pain levels. The bilateral sternal block also reduced morphine consumption. It improved the patients' satisfaction and rehabilitation, but no effects were noted on respiratory outcomes. No major adverse effect due to the treatment occurred, but the ropivacaine plasma level was greater than 4 mg/L in 1 patient. CONCLUSIONS: This technique may find a role within the framework of multimodal analgesia after sternotomy, although further confirmatory studies are needed.