Laparoscopic versus ultrasound-guided transversus abdominis plane block in colorectal surgery: a non-inferiority, multicentric randomized double-blinded clinical trial.

AIM: The aim of this study was to assess if laparoscopic-assisted transversus abdominis plane (TAP) block (L-TAPB) is as efficient as ultrasound-guided TAP block (U-TAPB) in postoperative pain control. METHOD: In all, 112 patients scheduled for elective laparoscopic colon resection from February 2018 to December 2021 at two Swiss hospitals were included and randomized in a 1:1 ratio before surgery with either L-TAPB or U-TAPB. The primary end-point was the non-inferiority of the L-TAPB compared to U-TAPB with regard to the total opioid consumption within the first 24 h after surgery. Data regarding patients' characteristics, opioid consumption, pain on the visual analogue scale, operative and anaesthesia induction time, complications and length of stay were collected and analysed. RESULTS: Fifty-five patients were allocated to the L-TAPB and fifty-seven to the U-TAPB. No significant difference was found in the overall dose of opioids within 24 h, and the non-inferiority of the L-TAPB was confirmed. There were almost twice as many patients in the L-TAPB group requesting opioid reserves compared to the U-TAPB group (54.5% vs. 29.8%, P = 0.008). The anaesthesia induction time was significantly longer in the U-TAPB group (17 ± 11 min vs. 23 ± 12 min, P = 0.014). For all other variables (pain on the visual analogue scale, opioid consumption, need of epidural analgesia, operating time, postoperative complications and hospital stay) no statistically significant difference between the L-TAPB and the U-TAPB groups was noted. CONCLUSION: Our results showed the non-inferiority of the laparoscopic delivery compared to ultrasound-guided administration of the TAP block, with the advantage of not affecting anaesthesia times. STUDY REGISTRATION NUMBER: 2017-02017 CE 3294, ClinicalTrials.gov identifier NCT04575233.

Fabry-Stroke Italian Registry (FSIR): a nationwide, prospective, observational study about incidence and characteristics of Fabry-related stroke in young-adults. Presentation of the study protocol.

BACKGROUND: TIA and stroke, both ischemic and hemorrhagic, may complicate Fabry disease at young-adult age and be the first manifestation that comes to the clinician's attention. No definite indications have yet been elaborated to guide neurologists in Fabry disease diagnostics. In current practice, it is usually sought in case of cryptogenic strokes (while Fabry-related strokes can also occur by classical pathogenic mechanisms) or through screening programs in young cerebrovascular populations. Data on recurrence and secondary prevention of Fabry's stroke are scanty. METHODS: The study had a prospective observational design involving 33 Italian neurological Stroke Units. Considering the incidence of TIA/stroke in the European population aged < 60 years and the frequency of Fabry disease in this category (as foreseen by a pilot study held at the Careggi University-Hospital, Florence), we planned to screen for Fabry disease a total of 1740 < 60-year-old individuals hospitalized for TIA, ischemic, or hemorrhagic stroke. We investigated TIA and stroke pathogenesis through internationally validated scales and we gathered information on possible early signs of Fabry disease among all cerebrovascular patients. Every patient was tested for Fabry disease through dried blood spot analysis. Patients who received Fabry disease diagnosis underwent a 12-month follow-up to monitor stroke recurrence and multi-system progression after the cerebrovascular event. DISCUSSION: The potential implications of this study are as follows: (i) to add information about the yield of systematic screening for Fabry disease in a prospective large cohort of acute cerebrovascular patients; (ii) to deepen knowledge of clinical, pathophysiological, and prognostic characteristics of Fabry-related stroke.

Preoperative intra-aortic balloon pump to reduce mortality in coronary artery bypass graft: a meta-analysis of randomized controlled trials.

INTRODUCTION: The intra-aortic balloon pump is routinely used in cardiac surgery; however, its impact on outcome is still a matter of debate and several randomized trials have been published recently. We perform an updated meta-analysis of randomized controlled trials that investigated the use of preoperative intra-aortic balloon pump in adult patients undergoing coronary artery bypass grafting. METHODS: Potentially eligible trials were identified by searching the Medline, Embase, Scopus, ISI Web of Knowledge and The Cochrane Library. Searches were not restricted by language or publication status and were updated in August 2014. Randomized controlled trials on preoperative intra-aortic balloon pump in patients undergoing coronary artery bypass grafting either with or without cardiopulmonary bypass were identified. The primary end point was mortality at the longest follow-up available and the secondary end point was 30-day mortality. RESULTS: The eight included randomized clinical trials enrolled 625 patients (312 to the intra-aortic balloon pump group and 313 to control). The use of intra-aortic balloon pump was associated with a significant reduction in the risk of mortality (11 of 312 (3.5%) versus 33 of 313 (11%), risk ratio = 0.38 (0.20 to 0.73), P for effect = 0.004, P for heterogeneity = 0.7, I-square = 0%, with eight studies included). The benefit on mortality reduction was confirmed restricting the analysis to trials with low risk of bias, to those reporting 30-day follow-up and to patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass. CONCLUSIONS: Preoperative intra-aortic balloon pump reduces perioperative and 30-day mortality in high-risk patients undergoing elective coronary artery bypass grafting.

Sequential endovascular thrombectomy approach (SETA) to acute ischemic stroke: preliminary single-centre results and cost analysis.

INTRODUCTION: We report the preliminary results of a single-centre experience in the endovascular treatment (ET) of acute ischemic stroke (AIS) with a sequential endovascular thrombectomy approach (SETA), which comprehends a direct aspiration first-pass technique (ADAPT) eventually followed by stent retriever thrombectomy. MATERIALS AND METHODS: We prospectively analyzed data from 16 patients with severe to moderate AIS and CT angiography demonstration of large intracranial vessel occlusion treated with SETA between July 2013 and March 2014. We evaluated recanalization rate, clinical outcome after 90 days as well as differential costs of aspiration and stent-assisted thrombectomy. RESULTS: A group of 16 patients met the eligibility criteria to undergo ET with a baseline NIHSS score of 22 (range 12-39). In 15/16 cases, we obtained target vessel recanalization, 11 cases with ADAPT technique alone. Modified rankin score (mRS) at 90 days follow-up was ≤2 in 9/16 patients (56%). ADAPT technique had a lower device-related cost than stent-assisted thrombectomy leading to an overall saving of -2,747.28 . CONCLUSIONS: Our preliminary data suggest that a SETA beginning with direct aspiration could be useful to optimize ET of stroke in terms of invasiveness, safety and cost-effectiveness allowing recanalization with low complication rate.

Prevalence of Fabry disease and GLA variants in young patients with acute stroke: The challenge to widen the screening. The Fabry-Stroke Italian Registry.

BACKGROUND: Fabry disease (FD) is a treatable X-linked lysosomal storage disorder caused by GLA gene variants leading to alpha-galactosidase A deficiency. FD is a rare cause of stroke, and it is still controversial whether in stroke patients FD should be searched from the beginning or at the end of the diagnostic workup (in cryptogenic strokes). METHODS: Fabry-Stroke Italian Registry is a prospective, multicentric screening involving 33 stroke units. FD was sought by measuring α-galactosidase A activity (males) and by genetic tests (males with reduced enzyme activity and females) in patients aged 18-60 years hospitalized for TIA, ischemic stroke, or intracerebral hemorrhage. We diagnosed FD in patients with 1) already known pathogenic GLA variants; 2) novel GLA variants if additional clinical, laboratory, or family-derived criteria were present. RESULTS: Out of 1906 patients, we found a GLA variant in 15 (0.79%; 95%CI 0.44-1.29) with a certain FD diagnosis in 3 (0.16%; 95%CI 0.03-0.46) patients, none of whom had hemorrhage. We identified 1 novel pathogenic GLA variant. Ischemic stroke etiologies in carriers of GLA variants were: cardioaortic embolism (33%), small artery occlusion (27%), other causes (20%), and undetermined (20%). Mild severity, recurrence, previous TIA, acroparesthesias, hearing loss, and small artery occlusion were predictors of GLA variant. CONCLUSION: In this large multicenter cohort the frequency of FD and GLA variants was consistent with previous reports. Limiting the screening for GLA variants to patients with cryptogenic stroke may miss up to 80% of diagnoses. Some easily recognizable clinical features could help select patients for FD screening.

Percutaneous tracheostomy in COVID-19 patients: a new apneic approach.

BACKGROUND: Percutaneous dilation tracheostomy is an aerosol-generating procedure carrying a documented infectious risk during respiratory virus pandemics. For this reason, during the COVID-19 outbreak, surgical tracheostomy was preferred to the percutaneous one, despite the technique related complications increased risk. METHODS: We describe a new sequence for percutaneous dilation tracheostomy procedure that could be considered safe both for patients and healthcare personnel. A fiberscope was connected to a video unit to allow bronchoscopy. Guidewire positioning was performed as usual. While the established standard procedure continues with the creation of the stoma without any change in mechanical ventilation, we retracted the bronchoscope until immediately after the access valve in the mount tube, allowing normal ventilation. After 3 minutes of ventilation with 100% oxygen, mechanical ventilation was stopped without disconnecting the circuit. During apnea, the stoma was created by dilating the trachea and the tracheostomy cannula was inserted. Ventilation was then resumed. We evaluated the safeness of the procedure by recording any severe desaturation and by performing serological tests to all personnel. RESULTS: Thirty-six patients (38%) of 96 underwent tracheostomy; 22 (23%) percutaneous dilation tracheostomies with the new approach were performed without any desaturation. All personnel (150 operators) were evaluated for serological testing: 9 (6%) had positive serology but none of them had participated in tracheostomy procedures. CONCLUSION: This newly described percutaneous dilation tracheostomy technique was not related to severe desaturation events and we did not observe any positive serological test in health workers who performed the tracheostomies.

A systematic review on levosimendan in paediatric patients.

Levosimendan is a calcium-sensitizing agent that improves cardiac function, hemodynamic performance, and survival in critically ill adult patient. Few data exist on its off-label use in paediatric patients. We therefore performed a systematic review updated in September 2013 of all the published articles describing the use of levosimendan in paediatric patients. We identified 24 studies published in the period 2004-2013 that included a total of 623 patients, the largest one being a case series of 293 patients. Most of the patients underwent cardiac surgery, other settings consisting of chronic heart failure, primary congenital heart diseases and sepsis and cancer-associated cardiac dysfunction. Most studies reported improvement in ventricular function, central venous oxygen saturation, serum lactate levels or cardiac index. The 5 randomized studies published so far have all been performed in cardiac surgery and suggest a beneficial effect on hemodynamic data with no effect on intensive care unit stay, hospital stay or survival. Side effects (e.g. hypotension) were reported. This inodilator merits to be investigated with further randomized trials focusing on clinically relevant outcomes.

Beneficial impact of levosimendan in critically ill patients with or at risk for acute renal failure: a meta-analysis of randomized clinical trials.

INTRODUCTION: The incidence of Acute Kidney Injury is nowadays high in critically ill patients. Its etiology is multifactorial and a primary role is played by low cardiac output syndrome. Everything targeted to normalize cardiac output should increase the renal perfusion and abolish the secondary vasoconstriction. Levosimendan is a calcium sensitizer drug with inotropic properties that improves cardiac output and seems to increase renal blood flow. The aim of this meta-analysis was to evaluate the role of levosimendan in critically ill patients with or at risk of Acute Kidney Injury. METHODS: We performed a meta-analysis of  randomized controlled trials searching for trials that compared levosimendan with any comparator. The endpoints were the number of patients receiving Renal Replacement Therapy after randomization and the number of patients developing Acute Kidney Injury. RESULTS: Final analysis included 33 trials and 3,879 patients (2,024 levosimendan and 1,855 control). The overall analysis showed that the use of levosimendan was associated with a significant reduction in the risk of Renal Replacement Therapy (17 of 492 [3.5%] in the levosimendan group versus 37 of 427 [8.7%] in the control group, relative risk =0.52 [0.32 to 0.86], p for effect =0.01) and of Acute Kidney Injury (114 of 1,598 [7.1%] in the levosimendan group versus 143 of 1,529 [9.4%] in the control arm, relative risk =0.79 [0.63 to 0.99], p for effect =0.048). CONCLUSIONS: This meta-analysis suggests that the use of levosimendan is associated with a significant reduction of Renal Replacement Therapy in critically ill patients.

ß-adrenergic agonist infusion during extracorporeal lung perfusion: effects on glucose concentration in the perfusion fluid and on lung function.

BACKGROUND: We recently showed in a pig model of ex vivo lung perfusion (EVLP) that lung edema correlates with glucose consumption. We investigated whether salbutamol, a ß-adrenergic receptor agonist known to upregulate fluid transport in the lung, modulates glucose concentration in the perfusate during EVLP. METHODS: Lungs from domestic pigs underwent normothermic EVLP. At the end of controlled reperfusion, lungs were ventilated and perfused for 60 minutes, then randomized to salbutamol (ß-Agonist) infusion or placebo (Control) for 180 minutes. Functional parameters were assessed. RESULTS: In the ß-Agonist group, glucose concentration decreased over time more than corresponding Control values (analysis of variance [ANOVA], p = 0.05). Mean pulmonary artery pressure (mPAP) was 16 ± 1 mm Hg in the ß-Agonist group vs 21 ± 1 mm Hg in the Controls (ANOVA p < 0.05). Baseline mPAP was correlated with the drop of mPAP after the ß-agonist infusion (R(2) = 0.856, p < 0.05). Dynamic compliance dropped from 51 ± 10 to 31 ± 6 ml/cm H(2)O in the ß-Agonist group and from 60 ± 4 to 21 ± 3 ml/cm H(2)O in the Control group (ANOVA, p < 0.05 ß-agonist vs Control). The Δ partial pressure of oxygen/fraction of inspired oxygen was 418 ± 15 and 393 ± 12 mm Hg in the ß-Agonist and Control groups, respectively (t-test p = 0.106). CONCLUSIONS: Glucose concentration in the perfusate was affected by salbutamol. Salbutamol was associated with lower pulmonary pressures and better lung mechanics. These data suggest a possible role for salbutamol as a pharmacologic adjunct during EVLP before transplantation.