Effects of an open lung extubation strategy compared with a conventional extubation strategy on postoperative pulmonary complications after general anesthesia: a single-centre pilot randomized controlled trial.

PURPOSE: Postoperative pulmonary complications (PPCs) are a common cause of morbidity. Postoperative atelectasis is thought to be a significant risk factor in their development. Recent imaging studies suggest that patients' extubation may result in similar postoperative atelectasis regardless of the intraoperative mechanical ventilation strategy used. In this pilot trial, we hypothesized that a study investigating the effects of an open lung extubation strategy compared with a conventional one on PPCs would be feasible. METHODS: We conducted a pilot, single-centre, double-blinded randomized controlled trial. Adult patients at moderate to high risk of PPCs and scheduled for elective surgery were eligible. Patients were randomized to an open lung extubation strategy (semirecumbent position, fraction of inspired oxygen [FIO2] 50%, pressure support ventilation, unchanged positive end-expiratory pressure) or to a conventional extubation strategy (dorsal decubitus position, FIO2 100%, manual bag ventilation). The primary feasibility outcome was global protocol adherence while the primary exploratory efficacy outcome was PPCs. RESULTS: We randomized 35 patients to the conventional extubation group and 34 to the open lung extubation group. We observed a global protocol adherence of 96% (95% confidence interval, 88 to 99), which was not different between groups. Eight PPCs occurred (two in the conventional extubation group vs six in the open lung extubation group). Less postoperative supplemental oxygen and better lung aeration were observed in the open lung extubation group. CONCLUSIONS: In this single-centre pilot trial, we observed excellent feasibility. A multicentre pilot trial comparing the effect of an open lung extubation strategy with that of a conventional extubation strategy on the occurrence of PPCs is feasible. STUDY REGISTRATION DATE: ClinicalTrials.gov (NCT04993001); registered 6 August 2021.

RéSUMé: OBJECTIF: Les complications pulmonaires postopératoires (CPP) sont une cause fréquente de morbidité. L'atélectasie postopératoire est considérée comme un facteur de risque important de CPP. Des études d'imagerie récentes suggèrent que l'extubation des patient·es peut entraîner une atélectasie postopératoire semblable, quelle que soit la stratégie de ventilation mécanique peropératoire utilisée. Dans cet essai pilote, nous avons émis l'hypothèse qu'une étude examinant les effets sur les CPP d'une stratégie d'extubation à poumon ouvert par rapport à une stratégie d'extubation conventionnelle serait réalisable. MéTHODE: Nous avons mené une étude randomisée contrôlée pilote, monocentrique et à double insu. Les patient·es adultes présentant un risque modéré à élevé de CPP et devant bénéficier d'une chirurgie non urgente étaient éligibles. Les patient·es ont été randomisé·es à une prise en charge par une stratégie d'extubation à poumon ouvert (position semi-couchée, fraction d'oxygène inspiré [FIO2] 50 %, ventilation par aide inspiratoire, pression positive télé-expiratoire inchangée) ou à une stratégie d'extubation conventionnelle (décubitus dorsal, FIO2 100 %, ventilation manuelle par masque). Le principal critère de faisabilité était l'adhésion au protocole global, tandis que les CPP constituaient le principal critère d'efficacité exploratoire. RéSULTATS: Nous avons randomisé 35 patient·es dans le groupe d'extubation conventionnelle et 34 dans le groupe d'extubation à poumon ouvert. Nous avons observé une adhésion globale au protocole de 96 % (intervalle de confiance à 95 %, 88 à 99), qui n'était pas différente entre les groupes. Huit CPP sont survenues (deux dans le groupe d'extubation conventionnelle vs six dans le groupe d'extubation à poumon ouvert). Nous avons observé des besoins moins importants en oxygène supplémentaire postopératoire et une meilleure aération pulmonaire dans le groupe extubé à poumon ouvert. CONCLUSION: Dans cet essai pilote monocentrique, nous avons observé une excellente faisabilité. Une étude pilote multicentrique comparant l'effet d'une stratégie d'extubation à poumon ouvert à celui d'une stratégie d'extubation conventionnelle sur la survenue de CPP est réalisable. DATE D'ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT04993001); enregistrée le 6 août 2021.

A Medicoeconomic Evaluation of a Telehealth Platform for Elective Outpatient Surgeries: Protocol for a Randomized Controlled Trial.

BACKGROUND: The number of elective outpatient surgeries in Canada has increased markedly in the last 10 years. However, unanticipated cancellations on the day of surgery and adverse postoperative events are frequent. Modern technologies have been shown to be of great help in the medical field in improving patient care. Thus, it is likely that dedicated technologies could also significantly improve surgical outpatients' pathways. Therefore, the department of anesthesiology at the University of Montreal Medical Center, in collaboration with LeoMed, a telemedicine platform, has developed a telehealth solution to offer more efficient perioperative support and follow-up for patients undergoing ambulatory surgery. OBJECTIVE: The objective is to evaluate the medicoeconomic benefit of a dedicated perioperative telehealth platform for patients undergoing day surgery. Our hypothesis is that this dedicated telecare solution will allow more efficient patient care, which will reduce all types of medical costs related to day surgery pathways. METHODS: This study is a single-center, single-blinded, 2-group randomized controlled trial. One thousand patients aged over 18 years with internet access who are scheduled to undergo ambulatory surgery will be enrolled and randomized either to follow a perioperative path that includes a patient-tailored perioperative digital app via the LeoMed telecare platform for 1 month or to follow the standard of care, which does not offer personalized digital support. The primary outcome will be to evaluate the cost-effectiveness of the telecare platform, assessing direct costs from factors such as unanticipated cancellations on the day of surgery due to preoperative instructions not being followed, calls to the local health information line, calls to the provincial health information line, emergency department consultations, unplanned readmissions, or medical visits for problems related to the surgical procedure within the first 30 days after the intervention. The secondary outcome will be to evaluate cost utility using a questionnaire assessing quality-adjusted life years. A blinded independent research team will analyze outcomes. All data will be analyzed according to the intention-to-treat principle. A sample size of 500 subjects in each group was calculated to detect a 21% reduction in postoperative complications with a power of 90%. This study has been approved by the ethics board of Centre hospitalier de l'Université de Montréal (University of Montreal Health Centre). No employee of LeoMed was involved in the study conception, and none will be involved in either data collection or analysis. RESULTS: Results of this trial will be useful to determine the economic benefit of a telecare platform specifically developed for surgical outpatient pathways. CONCLUSIONS: We believe that the deployment of a dedicated perioperative telehealth app will lead to better patient care and fewer postoperative complications, which will lower all types of costs related to surgical outpatient care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04948632; https://ClinicalTrials.gov/ct2/show/NCT04948632. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44006.

Preoperative Fibrinogen Level and Bleeding in Liver Transplantation for End-stage Liver Disease: A Cohort Study.

BACKGROUND: Liver transplantation is a high-risk surgery associated with important perioperative bleeding and transfusion needs. Uncertainties remain on the association between preoperative fibrinogen level and bleeding in this population. METHODS: We conducted a cohort study that included all consecutive adult patients undergoing a liver transplantation for end-stage liver disease in 1 center. We analyzed the association between the preoperative fibrinogen level and bleeding-related outcomes. Our primary outcome was intraoperative blood loss, and our secondary outcomes were estimated perioperative blood loss, intraoperative and perioperative red blood cell transfusions, reinterventions for bleeding and 1-y graft and patient survival. We estimated linear regression models and marginal risk models adjusted for all important potential confounders. We used restricted cubic splines to explore potential nonlinear associations and reported dose-response curves. RESULTS: We included 613 patients. We observed that a lower fibrinogen level was associated with a higher intraoperative blood loss, a higher estimated perioperative blood loss and a higher risk of intraoperative and perioperative red blood cell transfusions (nonlinear effects). Based on an exploratory analysis of the dose-response curves, these effects were observed below a threshold value of 3 g/L for these outcomes. We did not observe any association between preoperative fibrinogen level and reinterventions, 1-y graft survival or 1-y patient survival. CONCLUSIONS: This study suggests that a lower fibrinogen level is associated with bleeding in liver transplantation. The present results may help improving the selection of patients for further studies on preoperative fibrinogen administration in liver transplant recipients with end-stage liver disease.

Association of Phlebotomy on Blood Product Transfusion Requirements During Liver Transplantation: An Observational Cohort Study on 1000 Cases.

Background: During the past 2 decades, transfusion requirements have decreased drastically during orthotopic liver transplantation (OLT), and transfusion-free transplantation is nowadays increasingly common. Understanding that liberal intravenous volume loading in cirrhotic patients may have detrimental consequences is key. In contrast, phlebotomy is a method to lower central venous pressure and portal venous pressure. The objective of this study was to determine the effectiveness and safety of phlebotomy in the early phase of blood transfusion, blood loss, renal function, and mortality. Methods: The present study evaluated the impact of phlebotomy on bleeding, transfusion rate, renal dysfunction, and mortality in 1000 consecutive OLTs. Two groups were defined and compared using phlebotomy. Multivariate logistic and linear regression models were used to determine predictors of bleeding, red blood cell (RBC) transfusion, renal dysfunction, and mortality. Results: A mean of 0.7 ± 1.5 RBC units was transfused per patient for 1000 OLTs, 75% did not receive any RBCs, and the median and interquartile range (25-75) were 0 for all blood products transfused. The phlebotomy was associated with decreased transfusion (RBCs, plasma, platelets, cryoprecipitate, albumin), with less bleeding, and with an increased survival rate, both 1 mo and 1 y. Phlebotomy was not associated with renal dysfunction. Conclusions: The practice of phlebotomy to lower portal venous pressure was associated with reduced blood product transfusions and blood loss during liver dissection without deleterious effect on renal function.

Elements not Graded in the Cardiac Enhanced Recovery After Surgery Guidelines Might Improve Postoperative Outcome: A Comprehensive Narrative Review.

Enhanced Recovery Programs (ERPs) are protocols involving the whole patient surgical journey. These protocols are based on multimodal, multidisciplinary, evidence-based, and patient-centered approaches aimed at improving patient recovery after a surgical intervention. Such programs have shown striking positive results in different surgical specialties. However, only a few research groups have incorporated preoperative, intraoperative, and postoperative evidence-based interventions in bundles used to standardize care and build cardiac surgery ERPs. The Enhanced Recovery After Surgery Society recently published evidence-based recommendations for perioperative care in cardiac surgery. Their recommendations included 22 perioperative interventions that may be part of any cardiac ERP. However, various components integrated in already-published cardiac ERPs were neither graded nor reported in these recommendations. The goals of the current review are to present published cardiac ERPs and their effects on patient outcomes and reported components incorporated into these ERPs and to discuss the objectives and scope of cardiac ERPs.

Feasibility and postoperative opioid sparing effect of an opioid-free anaesthesia in adult cardiac surgery: a retrospective study.

BACKGROUND: No previous study investigated the dexmedetomidine-based opioid-free anesthesia (OFA) protocol in cardiac surgery. The main objective of this study was to evaluate the feasibility and the postoperative opioid-sparing effect of dexmedetomidine-based OFA in adult cardiac surgery patients. METHODS: We conducted a single-centre and retrospective study including 80 patients above 18 years old who underwent on-pump cardiac surgery between November 2018 and February 2020. Patients were divided into two groups: OFA (lidocaine, ketamine, dexmedetomidine, MgSO4) or opioid-based anaesthesia (remifentanil and anti-hyperalgesic medications such as ketamine and/or MgSO4 and/or lidocaine at the discretion of the anesthesiologist). The primary endpoint was the total amount of opioid consumed in its equivalent of intravenous morphine during the first 48 postoperative hours. Secondary outcomes included perioperative hemodynamics, post-operative maximal pain at rest and during coughing and adverse outcomes. Data are expressed as median [interquartile range]. RESULTS: Patients in the OFA-group had a higher EuroSCORE II, with more diabetes, more dyslipidemia and more non-elective surgery but fewer smoking history. In the OFA group, the median loading dose of dexmedetomidine was 0.6 [0.4-0.6] µg.kg- 1 while the median maintenance dose was 0.11 µg.kg- 1.h- 1 [0.05-0.20]. In 10 (25%) patients, dexmedetomidine was discontinued for a drop of mean arterial pressure below 55 mmHg. The median total amount of opioid consumed in its equivalent of intravenous morphine during the first 48 postoperative hours was lower in the OFA group (15.0 mg [8.5-23.5] versus 30.0 mg [17.3-44.3], p < 0.001). While no differences were seen with rest pain (2.0 [0.0-3.0] versus 0.5 [0.0-5.0], p = 0.60), the maximal pain score during coughing was lower in OFA group (3.5 [2.0-5.0] versus 5.5 [3.0-7.0], p = 0.04). In OFA group the incidence of atrial fibrillation (18% versus 40%, p = 0.03) and non-invasive ventilation use (25% versus 48%, p = 0.04) were lower. The incidence of bradycardia and the intraoperative use of norepinephrine were similar between both groups. CONCLUSION: Dexmedetomidine-based OFA in cardiac surgery patients is feasible and could be associated with a lower postoperative morphine consumption and better postoperative outcomes. Further randomized studies are required to confirm these promising results and determine the optimal associations, dosages, and infusion protocols during cardiac surgery.

U-shaped relationship between pre-operative plasma fibrinogen levels and severe peri-operative bleeding in cardiac surgery.

BACKGROUND: An inverse linear relationship has been reported between pre-operative fibrinogen levels and postoperative blood loss in cardiac surgery. However, recently high pre-operative fibrinogen levels have also been reported to be associated with increased blood transfusion and re-operation. OBJECTIVE: We tested the hypothesis that the relationship between pre-operative fibrinogen levels and severe peri-operative bleeding is not linear. DESIGN: A large-scale (n = 3883) single-centre retrospective study. SETTING: A tertiary care teaching hospital. PATIENTS: We analysed data from our institutional database which includes all patients above 18 years who underwent on-pump cardiac surgery through a sternotomy between September 2010 and May 2014. MAIN OUTCOME MEASURES: Peri-operative severe bleeding adapted from the Universal Definition of Peri-operative Bleeding, class 3 or 4. The relationship between pre-operative fibrinogen levels and peri-operative severe bleeding was analysed by binary logistic regression. A cubic B-spline transformation was used to estimate the relationship between pre-operative fibrinogen level associated with excessive peri-operative bleeding. RESULTS: Severe peri-operative bleeding was observed in 957 (24.6%) patients. An L-shaped relationship was observed between pre-operative fibrinogen levels and 24-h postoperative blood loss. The relationship between pre-operative fibrinogen levels and severe peri-operative bleeding (i.e. Universal Definition of Peri-operative Bleeding class 3 or 4) was U-shaped: the risk of severe peri-operative bleeding bottomed at 3.3 g l when the upward sloping curve started at 5.8 g l with a steeper increase above 8.2 g l. CONCLUSION: We reported a U-shaped relationship between severe peri-operative bleeding and pre-operative fibrinogen levels. While a low-level of fibrinogen appears to be associated with a high risk of bleeding, a high level does not necessarily protect the patient against such a risk and could even be a risk factor for peri-operative bleeding.

Autonomous Systems in Anesthesia: Where Do We Stand in 2020? A Narrative Review.

As most of us are aware, almost every facet of our society is becoming, for better or worse, progressively more technology-dependent. Technological advancement has made autonomous systems, also known as robots, an integral part of our life in several fields, including medicine. The application of robots in anesthesia could be classified into 3 types of robots. The first ones are pharmacological robots. These robots are based on closed-loop systems that allow better-individualized anesthetic drug titration for optimal homeostasis during general anesthesia and sedation. Recent evidence also demonstrates that autonomous systems could control hemodynamic parameters proficiently outperforming manual control in the operating room. The second type of robot is mechanical. They enable automated motorized reproduction of tasks requiring high manual dexterity level. Such robots have been advocated to be more accurate than humans and, thus, could be safer for the patient. The third type is a cognitive robot also known as decision support system. This type of robot is able to recognize crucial clinical situation that requires human intervention. When these events occur, the system notifies the attending clinician, describes relevant related clinical observations, proposes pertinent therapeutic options and, when allowed by the attending clinician, may even administer treatment. It seems that cognitive robots could increase patients' safety. Robots in anesthesia offer not only the possibility to free the attending clinicians from repetitive tasks but can also reduce mental workload allowing them to focus on tasks that require human intelligence such as analytical and clinical approach, lifesaving decision-making capacity, and interpersonal interaction. Nevertheless, further studies have yet to be done to test the combination of these 3 types of robots to maintain simultaneously the homeostasis of multiple biological variables and to test the safety of such combination on a large-scale population.

Automated systems for perioperative goal-directed hemodynamic therapy.

Perioperative goal-directed hemodynamic therapy (GDHT) has evolved from invasive "supra-physiological" maximization of oxygen delivery to minimally or even noninvasively guided automated stroke volume optimization. Over the past four decades, investigators have simultaneously developed novel monitors, updated strategies, and automated technologies to improve GDHT. Decision support technology, which proposes an intervention based on the patient's real time physiologic status, was an important step towards automation. Closed-loop systems have now been created to both increase GDHT compliance and decrease physician workload. These automated systems offer an elegant approach to optimize cardiac output and end-organ perfusion during the perioperative period. Most notably, automated preload optimization guided by dynamic indicators of fluid responsiveness has shown its feasibility, safety, and impact. Making the leap into fully automated GDHT has been accomplished on a small scale, but there are considerable challenges that must be surpassed before integrating all hemodynamic components into an automated system during general anesthesia. In this review, we will discuss the evolution and potential future of automated GDHT during the perioperative period.

Reduced Length of Hospital Stay for Cardiac Surgery-Implementing an Optimized Perioperative Pathway: Prospective Evaluation of an Enhanced Recovery After Surgery Program Designed for Mini-Invasive Aortic Valve Replacement.

OBJECTIVES: Presently, there is enthusiasm for the Enhanced Recovery After Surgery (ERAS) program. The literature clearly indicates this type of program could shorten hospital length of stay and improve patient outcome. However, most of the studies conducted have encompassed mainly colorectal and orthopedic surgeries. Thus, in an effort to provide more evidence to the literature, the authors prospectively investigated the feasibility and clinical effectiveness of a dedicated ERAS program for mini-invasive aortic valve replacements (MIAVRs). DESIGN: Observational before-and-after trial. SETTING: University hospital. PARTICIPANTS: Consecutive patients scheduled for an MIAVR via a mini-sternotomy during 2 time periods-before (MIAVR group) and after implementation of an ERAS program (MIAVR-ERAS group). INTERVENTIONS: Patients in the dedicated MIAVR-ERAS group followed a dedicated pathway specifically designed for this procedure, which encompasses several evidence-based medicine elements for cardiac surgery. MEASUREMENTS AND MAIN RESULTS: Data on patient demographics, patient characteristics, compliance to the ERAS protocol, postoperative morphine consumption, postoperative pain scores, postoperative complications, hospital length of stay, and hospital readmission rate were collected and compared. Twenty-three patients were enrolled in each group. Patients enrolled in the new protocol had significantly lower postoperative pain scores (p = 0.03). The median hospital length of stay was 10 (9-13.5) and 7 (6.5-8) days in the traditional MIAVR group and in the MIAVR-ERAS group, respectively (p < 0.001). CONCLUSIONS: An ERAS pathway planned for MIAVR seems feasible and was associated with a shorter length of hospital stay with trends toward both less opioid consumption and less postoperative complications.

Intraoperative changes in blood lactate levels are associated with worse short-term outcomes after cardiac surgery with cardiopulmonary bypass.

BACKGROUND: A high perioperative blood lactate level has been reported to be associated with poor outcomes after cardiac surgery. More than isolated peaks of lactate values, it should be more interesting to take into account changes in intraoperative blood lactate level (∆Lact). This large-scale retrospective study evaluated the relationship between ∆Lact and overall intensive care unit morbidity and 30-day all-cause mortality. METHODS: Perioperative data from consecutive patients undergoing on-pump cardiac surgery between September 2010 and June 2016 were retrospectively analysed through our institutional database including clinical, transfusion and laboratory test results implemented prospectively by physicians. Blood lactate levels were initially measured after induction of anaesthesia (baseline) and periodically during the surgery. The ∆Lact was defined as the difference between the highest intraoperative blood lactate and the baseline lactate level and offered the opportunity to stratify patients into four subgroups: ⩽0, 0.1-0.9, 1-1.9 and ⩾2 mmol L-1. RESULTS: From the 7,795 patients found eligible during the study period, 7,447 patients were analysed. The median ∆Lact of our patients was 0.6 (0.3-1) mmol L-1. Most of the studied patients (65.9%) exhibited a ∆Lact between 0.1 and 0.9 mmol L-1. A concentration-dependent relationship was observed between ∆Lact and intensive care unit morbidity and 30-day mortality. After adjustment for co-variables, all ∆Lact > 0 was associated with an increase in overall intensive care unit morbidity. An independent relationship was also found between ∆Lact and 30-day mortality as of a 1 mmol L-1 increase. CONCLUSION: Our results suggest that ∆Lact is associated with poor short-term outcomes in adult cardiac surgical patients.

Effect of opioid-free anaesthesia on postoperative epidural ropivacaine requirement after thoracic surgery: A retrospective unmatched case-control study.

INTRODUCTION: Patients undergoing thoracic surgery are at risk of severe postoperative pain. Post-thoracotomy pain relief is usually provided with thoracic epidural analgesia (TEA). Intraoperative use of opioids may result in hyperalgesia and increase analgesics consumption. We investigated the effect of opioid-free anaesthesia (OFA) on epidural ropivacaine requirement after thoracotomy. METHODS: This retrospective study compared postoperative epidural ropivacaine requirement of patients undergoing open thoracotomy and receiving either opioid-based anaesthesia (OBA group) or a non-opioid regimen including clonidine, ketamine and lidocaine (OFA group). All patients received postoperative multimodal analgesia including both epidural analgesia and intravenous analgesics. The primary outcome was the cumulative first 48 postoperative hours epidural ropivacaine consumption. Secondary outcomes included postoperative pain scores, requirement for postoperative morphine titration, total opioid analgesics consumption within the first 48 postoperative hours, incidence of nausea and vomiting, intraoperative haemodynamic. RESULTS: From January 2015 to February 2018, 50 patients received an OBA and 25 received an OFA. The cumulative first 48 postoperative hours epidural ropivacaine consumption was significantly higher in the OBA-group (919 ± 311 mg versus 693 ± 270 mg, P = 0.002). Numerical Rating Scale at 6 and 24 h were significantly lower in the OFA-group (1[0-2] versus 3 [1-5], P = 0.0005 and 1[0-2] versus 3.5 [1-5], P = 0.001). In post-anaesthesia care unit, the proportion of patients requiring morphine was significantly higher in the OBA-group (42% versus 4%, P < 0.001). During anaesthesia, the OBA-group required more vasopressor support, while there were more hypertensive events in the OFA-group. CONCLUSION: OFA might reduce ropivacaine consumption, early postoperative pain scores and requirement for morphine titration after thoracotomy.

Health related quality of life and predictive factors six months after intensive care unit discharge.

BACKGROUND: Advances in critical care medicine have improved patients' survival rate. However, physical and cognitive sequels after Intensive Care Unit (ICU) discharge remain substantial. Our objectives were to evaluate the Health-related Quality of Life (HRQL) at 6-month after ICU discharge and identify the risk factors of this outcomes. METHODS: We performed a single-centre prospective observational study. The components of Short Form 36 (SF-36) were analysed for assessing HRQL on preadmission and at 3- and 6-month after ICU discharge. RESULTS: During the study period, 438 patients were eligible for recruitment and 220 of them were included in the trial. During the follow-up period, bodily pain and role limitations relating to emotion were both improved in comparison to the preadmission status while physical role component was lower at 3- and 6- month after ICU discharge. There was no other significant change in the SF-36 domains. Mental as well as physical aggregates remained also unchanged. Most of preadmission SF-36 scores were lower in patients who died within the first 6 months of follow-up compared to those who are still alive. Factors independently associated with the 6-month HRQL were age, preadmission HRQL score, SAPS II, prolonged mechanical ventilation (>3 days) and the occurrence of acute respiratory distress syndrome. CONCLUSION: In our Cohort, ICU stay does not seem to alter globally neither the mental nor the physical component of the HRQL at 6-month after the discharge. However, some domains of the SF-36 are subject to significant changes.

Transcatheter aortic valve implantation: General anesthesia using transesophageal echocardiography does not decrease the incidence of paravalvular leaks compared to sedation alone.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a valid option for patients with severe aortic stenosis judged to be at high surgical risk. For this procedure, there is no agreement on the appropriate type of anesthesia. Sedation offers several advantages, but general anesthesia (GA) leads to less paravalvular leaks (PVLs) probably because of the transesophageal echocardiography (TEE) guidance. The objective was to compare the incidence of PVL among patients receiving conscious sedation (TAVI-S) and patients receiving GA (TAVI-GA). We made the hypothesis that a referral center does not necessitate TAVI-GA to reduce the incidence of moderate-to-severe PVL. AIM: The primary outcome was the incidence of moderate-to-severe PVL at 30 days after the implantation. DESIGN AND SETTING: This study design was a retrospective observational trial in a university hospital. METHODS: The TAVI-S group underwent the procedure under conscious sedation. In the TAVI-GA group, an endotracheal tube and a TEE probe were inserted. After the valve deployment, PVL was assessed by hemodynamic and fluoroscopic measurements in the TAVI-S group. TEE was also used in the TAVI-GA group to evaluate the presence of PVL. When PVL was moderate or severe according to the Valve Academic Research Consortium criteria. RESULTS: TAVI-S and TAVI-GA were accomplished in 168 (67.5%) and 81 (32.5%) patients, respectively. Our results show no difference between the two groups regarding the incidence and grade of PVL. CONCLUSION: Performing TAVI under GA with TEE guidance is not associated with a lower incidence of moderate and severe PVL.