Contact-force local impedance algorithm to guide effective pulmonary vein isolation in AF patients: 1-year outcome from an international multicenter clinical setting.

BACKGROUND: The combination of highly localized impedance (LI) and contact force (CF) may improve tissue characterization and lesion prediction during radiofrequency (RF) pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). OBJECTIVE: We report the outcomes of our acute and long-term clinical evaluation of CF-LI-guided PVI in consecutive AF ablation cases from an international multicenter clinical setting. METHODS: Three hundred twenty-four consecutive patients from 20 European centers undergoing RF catheter ablation with the Stablepoint™ catheter were enrolled in the CHARISMA registry. Of these, 275 had a minimum follow-up of 1 year and were included in the primary analysis. RESULTS: The mean procedure duration was 115 ± 47 min, and the mean fluoroscopy time was 9.9 ± 6 min. At the end of the procedures, all PVs had been successfully isolated in all study patients. Minor complications were reported in 12 patients (4.4%). At 1 year, 36 (13.1%) patients had had an AF recurrence, and freedom from antiarrhythmic drugs and AF recurrence was achieved in 228 (82.9%) patients. The recurrence rate was higher in patients with persistent AF (21/116, 18.1%) than in those with paroxysmal AF (15/159, 9.4%; p = 0.0459). On multivariate logistic analysis adjusted for baseline confounders, only time > 6 months from first diagnosis of AF to ablation (HR = 2.93, 95%CI 1.03 to 8.36, p = 0.0459) was independently associated with recurrences. CONCLUSION: An ablation strategy for PVI guided by CF-LI technology proved safe and effective and resulted in a low recurrence rate of AF over 1-year follow-up, irrespective of the underlying AF type. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice. (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

The new neural pressure support (NPS) mode and the helmet: did we find the dynamic duo?

BACKGROUND: Noninvasive ventilation (NIV) is commonly used in clinical practice to reduce intubation times and enhance patient comfort. However, patient-ventilator interaction (PVI) during NIV, particularly with helmet interfaces, can be challenging due to factors such as dead space and compliance. Neurally adjusted ventilatory assist (NAVA) has shown promise in improving PVI during helmet NIV, but limitations remain. A new mode, neural pressure support (NPS), aims to address these limitations by providing synchronized and steep pressurization. This study aims to assess whether NPS per se improves PVI during helmet NIV compared to standard pressure support ventilation (PSV). METHODS: The study included adult patients requiring NIV with a helmet. Patients were randomized into two arms: one starting with NPS and the other with PSV; the initial ventilatory parameters were always set as established by the clinician on duty. Physiological parameters and arterial blood gas analysis were collected during ventilation trials. Expert adjustments to initial ventilator settings were recorded to investigate the impact of the expertise of the clinician as confounding variable. Primary aim was the synchrony time (Timesync), i.e., the time during which both the ventilator and the patient (based on the neural signal) are on the inspiratory phase. As secondary aim neural-ventilatory time index (NVTI) was also calculated as Timesync divided to the total neural inspiratory time, i.e., the ratio of the neural inspiratory time occupied by Timesync. RESULTS: Twenty-four patients were enrolled, with no study interruptions due to safety concerns. NPS demonstrated significantly longer Timesync (0.64 ± 0.03 s vs. 0.37 ± 0.03 s, p < 0.001) and shorter inspiratory delay (0.15 ± 0.01 s vs. 0.35 ± 0.01 s, p < 0.001) compared to PSV. NPS also showed better NVTI (78 ± 2% vs. 45 ± 2%, p < 0.001). Ventilator parameters were not significantly different between NPS and PSV, except for minor adjustments by the expert clinician. CONCLUSIONS: NPS improves PVI during helmet NIV, as evidenced by longer Timesync and better coupling compared to PSV. Expert adjustments to ventilator settings had minimal impact on PVI. These findings support the use of NPS in enhancing patient-ventilator synchronization and warrant further investigation into its clinical outcomes and applicability across different patient populations and interfaces. TRIAL REGISTRATION: This study was registered on www. CLINICALTRIALS: gov NCT06004206 Registry URL: https://clinicaltrials.gov/study/NCT06004206 on September 08, 2023.

Impact of atrial fibrillation phenotype and left atrial volume on outcome after pulmonary vein isolation.

AIMS: Pulmonary vein isolation (PVI) is increasingly performed in patients with atrial fibrillation (AF). Both AF phenotype and left atrial (LA) volume have been shown to influence ablation outcome. The inter-relationship of the two is incompletely understood. We aimed to investigate the impact of AF phenotype vs. LA volume on outcome after PVI. METHODS AND RESULTS: In a retrospective analysis of a prospective registry of patients undergoing a first PVI, the association of AF phenotype and LA volume index (LAVI) was assessed as well as their impact on AF recurrence during follow-up. Overall, 476 patients were enrolled (median age 63 years, 29% females, 65.8% paroxysmal AF). Obesity, hypertension, chronic kidney disease, and heart failure were all significantly more frequent in persistent AF. After 1 year, single-procedure, freedom from arrhythmia recurrence was 61.5%. Patients with paroxysmal AF had better outcomes compared with patients with persistent AF (65.6 vs. 52.7%, P = 0.003), as had patients with no/mild vs. moderate/severe LA dilation (LAVI <42 mL/m2 67.1% vs. LAVI ≥42 mL/m2 53%, P < 0.001). The combination of both parameters refined prediction of 1-year recurrence (P < 0.001). After adjustment for additional clinical risk factors in multivariable Cox proportional hazard analysis, both AF phenotype and LAVI ≥42 mL/m2 contributed significantly towards the prediction of 1-year recurrence. CONCLUSION: Atrial fibrillation phenotype and LA volume are independent predictors of outcome after PVI. Persistent AF with no/mild LA dilation has a similar risk of recurrence as paroxysmal AF with a moderate/severe LA dilation and should be given similar priority for ablation.

How to establish a successful and sustainable surgical atrial fibrillation program: key considerations on the arrhythmia, training and treatment strategies.

Establishing a successful and sustaining atrial fibrillation (AF) program should be current standard of care in cardiac surgery by providing not only sinus rhythm restoration but improving survival significantly. Recognition of AF as a serious cardiac disease impacting a considerable number of patients in terms of stroke, heart failure development and mortality is key when implementing a protocol to identify patients suitable for surgical ablation and a treatment standard according to the underlying pathology. The ablation strategy resulting in the best potential rhythm outcome should be chosen, and the applied access should follow this decision in a way that the optimal lesion set can be executed completely. A thorough follow-up is required to confirm results or make necessary adjustments to the implemented treatment protocol. This should be done in close collaboration with other treatment specialists such as cardiologists, electrophysiologists, primary care physicians, or neurologists. This collaboration might also facilitate an expansion of the program towards stand-alone ablation, ventricular tachycardia ablation, and inappropriate sinus tachycardia ablation.

Comparison of Dynamic Measures in Intraoperative Goal-Directed Fluid Therapy of Patients with Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy.

INTRODUCTION: Obesity increases the risk of morbidity and mortality during surgical procedures. Goal-directed fluid therapy (GDFT) is a new concept for perioperative fluid management that has been shown to improve patient prognosis. This study aimed to investigate the role of the Pleth Variability Index (PVI), systolic pressure variation (SPV), and pulse pressure variation (PPV) in maintaining tissue perfusion and renal function during GDFT management in patients undergoing laparoscopic sleeve gastrectomy (LSG). MATERIALS AND METHODS: Two hundred ten patients were enrolled in our prospective randomized controlled clinical trial. Demographic data, hemodynamic parameters, biochemical parameters, the amount of crystalloid and colloid fluid administered intraoperatively, and the technique of goal-directed fluid management used were recorded. Patients were randomly divided into three groups: PVI (n = 70), PPV (n = 70), and SPV (n = 70), according to the technique of goal-directed fluid management. Postoperative nausea and vomiting, time of return of bowel movement, and hospital stay duration were recorded. RESULTS: There was no statistically significant difference between the number of crystalloids administered in all three groups. However, the amount of colloid administered was statistically significantly lower in the SPV group than in the PVI group, and there was no significant difference in the other groups. Statistically, there was no significant difference between the groups in plasma lactate, blood urea, and creatinine levels. CONCLUSION: In LSG, dynamic measurement techniques such as PVI, SPV, and PPV can be used in patients with morbid obesity without causing intraoperative and postoperative complications. PVI may be preferred over other invasive methods because it is noninvasive.

Transcatheter options for atrial fibrillation treatment: an overview of the ablative techniques currently available and future perspectives.

Atrial fibrillation (AF) is the most common arrhythmia in the adult population and catheter ablation has emerged as an important rhythm-control strategy and is the most common cardiac ablation procedure performed worldwide. The antiarrhythmic drugs have demonstrated moderate efficacy in long-term maintenance of sinus rhythm; moreover, they are often not tolerated and are associated with adverse events. Catheter ablation has proven to be effective in treating AF, although long-term outcomes have been significantly less favorable in persistent AF than in paroxysmal. The current guidelines recommend catheter ablation as class I indication for patients whom antiarrhythmic drugs have failed or are not tolerated, and as first-line rhythm-control therapy in selected patients with symptomatic AF. Advances in technology and innovative ablation protocols resulted in a remarkable improvement of the efficacy outcomes after pulmonary vein isolation. This review seeks to provide an updated report of the current practices and approaches, and to describe the latest advances in technology that aim to improve procedural safety, efficacy and to reduce procedural requirements in terms of duration and fluoroscopy exposure.

Sex-specific outcomes after catheter ablation for persistent AF.

BACKGROUND: Sex-specific outcomes after catheter ablation (CA) for atrial fibrillation (AF) have reported conflicting findings. OBJECTIVE: We examined the impact of female sex on outcomes in patients with persistent AF (PsAF) from the Catheter Ablation for Persistent Atrial Fibrillation: A Multicentre Randomized Trial of Pulmonary Vein Isolation vs PVI with Posterior Left Atrial Wall Isolation (CAPLA) randomized trial. METHODS: A total of 338 patients with PsAF were randomized to pulmonary vein isolation (PVI) or PVI with posterior wall isolation (PWI). The primary outcome was arrhythmia recurrence at 12 months. Clinical and electroanatomical characteristics, arrhythmia recurrence, and quality of life were compared between women and men. RESULTS: Seventy-nine women (23.4%; PVI 37; PVI + PWI 42) and 259 men (76.6%; PVI 131; PVI + PWI 128) underwent AF ablation. Women were older {median age 70.4 (interquartile range [IQR] 64.8-74.6) years vs 64.0 (IQR 56.7-69.7) years; P < .001} and had more advanced left atrial electroanatomical remodeling. At 12 months, arrhythmia-free survival was lower in women (44.3% vs 56.8% in men; hazard ratio 1.44; 95% confidence interval 1.02-2.04; log-rank, P = .036). PWI did not improve arrhythmia-free survival at 12 months (hazard ratio 1.02; 95% confidence interval 0.74-1.40; log-rank, P = .711). The median AF burden was 0% in both groups (women: IQR 0.0%-2.2% vs men: IQR 0.0%-2.8%; P = .804). Health care utilization was comparable between women (36.7%) and men (30.1%) (P = .241); however, women were more likely to undergo a repeat procedure (17.7% vs 6.9%; P = .007). Women reported more severe baseline anxiety (average Hospital Anxiety and Depression Scale [HADS] anxiety score 7.5 ± 4.9 vs 6.3 ± 4.3 in men; P = .035) and AF-related symptoms (baseline Atrial Fibrillation Effect on Quality-of-Life Questionnaire [AFEQT] score 46.7 ± 20.7 vs 55.9 ± 23.0 in men; P = .002), with comparable improvements in psychological symptoms (change in HADS anxiety score -3.8 ± 4.6 vs -3.0 ± 4.5; P = .152 (change in HADS depression score -2.9 ± 5.0 vs -2.6 ± 4.0; P = .542) and greater improvement in AFEQT score compared with men at 12 months (change in AFEQT score +45.9 ± 23.1 vs +39.2 ± 24.8; P = .048). CONCLUSION: Women undergoing CA for PsAF report more significant symptoms and poorer quality of life at baseline than men. Despite higher arrhythmia recurrence and repeat procedures in women, the AF burden was comparably low, resulting in significant improvements in quality of life and psychological well-being after CA in both sexes.

Evaluation of the Possible Influence of Povidone Iodine (PVI) Solution and Polyhexanide (PHMB) on Wound Healing in Corneal Epithelial Regeneration.

This study investigates the possible toxic effects of the preoperative antiseptic substances povidone iodine (PVI) and polyhexanide (PHMB; Serasept® 2) on wound healing in ophthalmology. To assess this impact, human telomerase-immortalized corneal epithelial (hTCEpi) cells and human telomerase-immortalized conjunctival epithelial (hCjE) cells were exposed to 1% and 5% PVI or 0.04% PHMB for different periods to evaluate the cytotoxicity of these two antiseptics. Furthermore, the toxicity of these antiseptics was investigated in a human tissue-specific corneal epithelial construct and porcine eye culture model. The results reveal the high cytotoxicity of PVI and PHMB in the hTCEpi and hCjE in monolayer cell culture models, independent of the incubation time and concentration of these substances. However, after hTCEpi cell differentiation into a tissue-specific corneal epithelial construct, contact with these antiseptics for the relevant preoperative time did not alter cPARP1 or Ki67 expression. Furthermore, the wound-healing process in the porcine cornea was not significantly influenced after incubation with these antiseptics. In summary, corneal and conjunctival epithelial cell lines are very sensitive to PVI and PHMB, whereas no significant alterations were found in intact tissue-specific corneal epithelial constructs or porcine corneas. Therefore, we could not identify PVI and PHMB as reasons for postoperative eye irritation.

High efficiency single-catheter workflow for radiofrequency atrial fibrillation ablation in the QDOT catheter era.

BACKGROUND: High-power short-duration (HPSD) ablation may improve the consistency and efficiency of pulmonary vein isolation (PVI). The novel QDOT Micro™ catheter (Biosense Webster, Inc.) with temperature feedback and microelectrodes aims to enhance PVI efficiency and safety. This study wants to evaluate the feasibility, safety, and efficiency of a standardized single-catheter workflow for PVI using QDOT (Q-FLOW). METHODS: The Q-FLOW includes single transeptal access, radiofrequency encircling of the PVs using a power of 50 W in a temperature/flow-controlled mode, and validation of the circles with microelectrodes. A 1:1 propensity-matched cohort of patients treated with conventional power-controlled ablation using a circular mapping catheter (CMC-FLOW) was used to compare procedural and clinical outcomes. RESULTS: A total of 150 consecutive atrial fibrillation patients (paroxysmal 67%, persistent 33%) were included. First-pass isolation rate was 86%. Procedural time, X-ray time, and dose were significantly lower for the Q-FLOW vs the CMC-FLOW (67.2 ± 17.9 vs 88.3 ± 19.2 min, P < 0.001; 3.0 ± 1.9 vs 5.0 ± 2.4 min, P < 0.001; 4.3 ± 1.9 vs 6.4 ± 2.3 Gycm2, P < 0.001). Complications were numerically but not significantly lower in the Q-FLOW group (2 [1.3%] vs 7 [4.7%], P = 0.091). There was no difference in arrhythmia recurrence at 12 months (atrial arrhythmia-free survival rate, 87.5% vs 84.4%, P = 0.565). CONCLUSION: A streamlined single-catheter workflow for PVI using QDOT was feasible and safe, resulting in a high rate of first-pass isolation and a low complication rate. The Q-FLOW further improved the efficiency of PVI compared to the standard CMC-FLOW, without difference in the 12-month outcome.

Impact of Vein of Marshall Ethanol Infusion Combined with Anatomical Ablation for the Treatment of Persistent Atrial Fibrillation: A Long-Term Follow-Up Based on Implantable Loop Recorders.

BACKGROUND: The best ablation treatment for persistent atrial fibrillation (PeAF) patients is still debated. The vein of Marshall (VOM) seems to be a promising target for ablation and could be combined with a linear set of ablation lesions. The aim of our study is to evaluate the incidence of AF recurrences in a PeAF population treated with a comprehensive ablation approach consisting of VOM ethanol infusion (EI), pulmonary vein isolation (PVI), a left atrial (LA) roofline, a mitral line (guided by the newly formed lesion after alcohol infusion into the VOM and validated by pacing), and a cavotricuspid isthmus line. METHODS: Consecutive patients undergoing the first ablation procedure of catheter ablation (CA) for PeAF were enrolled. All patients underwent VOM-EI, PVI, and ablation lines along the roof of the LA, mitral, and cavotricuspid isthmus. LA voltage mapping before and after VOM-EI was also performed. An implantable loop recorder (ILR) was implanted at the end of the ablation in each patient. RESULTS: Thirty-one consecutive patients (66 ± 8 years and 71% male) affected by PeAF were included in this study. The VOM-EI procedural phase lasted 21.4 ± 10.1 min. PV isolation and lines were validated in all subjects. The ML block was achieved within 10.8 ± 8.7 min. At a mean follow-up of 12 ± 7 months, 27 out of 31 (87%) patients remained free from AT/AF recurrences. Among the patients with recurrences, two (50%) had incomplete ablation lesions and three (75%) had "suboptimal" VOM-EI. In 23/31 patients (74%), antiarrhythmic drugs (AADs) were discontinued after 1 month of follow-up. No significant complications were reported during the follow-up. CONCLUSIONS: this single-center experience demonstrates that VOM-EI systematically combined with an anatomical ablation set in patients with PeAF resulted in feasible, safe, and effective freedom from AF/AT recurrences in 87% of the population after a 1-year follow-up period according to an ILR.

Plethysmograph Variability Index Values in Healthy Neonates - An Observational Pilot Study.

OBJECTIVES: To establish normative data of plethysmograph variability index (PVI), a simple non-invasive tool to measure fluid responsiveness, in neonates. METHODS: All healthy term and late preterm neonates were enrolled. PVI was recorded by pulse-oximeter on first three days of life along with other vital parameters. Data was analysed using SPSS software. RESULTS: The median PVI value was noted to be 21 with a wide range. The distribution of PVI did not differ according to day of life/ gestational age/ gender/ weight for gestational age. It did not significantly correlate with heart rate, gestational age or birth weight. A weak positive correlation was noted between PVI and PI (Rho = 0.157, p <0.001). CONCLUSIONS: PVI normative data in neonates has been presented. Serial trend of PVI values is more useful than a single value in making clinical decisions.

Pulmonary vein isolation by means of a novel cryoballoon technology in paroxysmal atrial fibrillation patients: 1-year outcome from a large Italian multicenter clinical registry.

INTRODUCTION: Recently, a new cryoballoon (CB) technology (POLARx; Boston Scientific) has come onto the market. Preliminary data have shown that its acute safety and efficacy are similar to those of the first-generation CB. The aim of this study was to assess the medium-term outcome of pulmonary vein isolation (PVI) with the POLARxTM CB in a large multicenter registry. METHODS: We prospectively collected data on 125 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent PVI by means of a novel CB system. Two cases of transient phrenic nerve palsy occurred, with full recovery in the 48h post procedure; no major procedure-related adverse events were reported. During the 90-day blanking period, 4 (3.2%) patients experienced an early recurrence. After the blanking period, over a mean follow-up of 411 ± 62 days, 19 patients (15.2%) suffered an AF/atrial tachycardia (AT) recurrence. The 1-year freedom from AF/AT recurrence was 86.4% (n = 17): 10 (8%) patients had an AF recurrence, 6 (4.8%) had an AT occurrence and 1 (0.8%) suffered both events. Patients with AF/AT recurrences had both a shorter deflation time and total deflation time. Moreover, CB ablations with measured TTI < 90 s and TTI < 60 s were more frequent in patients without AF/AT recurrence (88.5% and 77.4%, respectively) than in those who experienced at least one AF/AT recurrence (67.5% and 55.0%, p = .001 and p = .005, respectively). CONCLUSION: The novel POLARx cryo-balloon system is safe and effective for PV isolation, displaying a 1-year freedom from atrial arrhythmia recurrence of 86.4%, which is in line to that reported with AFA-Pro CB or RF ablation. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. Registration date: January 4, 2019.

Sex differences in characteristics of atrial fibrillation recurrence post surgical pulmonary vein isolation.

Background: Prior studies demonstrated that female sex is associated with arrhythmia recurrence after endovascular pulmonary vein isolation (PVI). However, it is unknown if the sexes differ in outcome after video assisted thoracoscopic (VATS) PVI. The aim of this study was therefore to compare characteristics of recurrent AF episodes in a matched male and female population, using implantable loop recorders for continuous rhythm monitoring. Methods: 40 matched (based on propensity score) males (age: 60.0 ± 7.71 (45-75)) and females (age: 62.0 ± 7.0 (37-74)) were retrieved from an existing database from a prior conducted study by the cardiothoracic department of the OLVG hospital (1) containing patients who received an implantable looprecorder and underwent a VATS PVI between 2012 and 2017. Patients were continuously monitored for a period of 12 months after VATS PVI and AF characteristics were compared. Results: An equal number of males and females had AF episodes during all periods (P > 0.05). The number of AF episodes was higher in females, during the first 6 months (P = 0.01, P = 0.034). During the entire follow up, the total AF duration was longer in females (P = 0.01, for all periods) with shorter inter - episode intervals (P = 0.001, P = 0001, P = 0.04) and a higher AF burden (P = 0.003, P = 0001, P = 0.006). After 3 months, AF recurrences during the night were more frequently observed in female patients (P = 0.001, P = 0.001). Conclusions: AF episodes occur frequently in both sexes after VATS PVI and warrant frequent rhythm monitoring. The observed sex differences in AF burden after VATS PVI, calls for intensive rhythm monitoring and aggressive treatment of recurrent AF epsiodes in females.

Long-Term Follow-Up In Paroxysmal Atrial Fibrillation Patients With Documented Isolated Trigger.

Aims: Supraventricular tachycardias may trigger atrial fibrillation (AF). The aim of the study was to evaluate the prevalence of supraventricular tachycardia (SVT) inducibility in patients referred for AF ablation and to evaluate the effects of SVT ablation on AF recurrences. Methods and results: 249 patients (mean age: 54 ± 14 years) referred for paroxysmal AF ablation were studied. In all patients, only AF relapses had been documented in the clinical history. 47 patients (19%; mean age: 42 ± 11 years) had inducible SVT during the electrophysiological study and underwent an ablation targeted only at SVT suppression. Ablation was successful in all 47 patients. The ablative procedures were: 11 slow-pathway ablations for atrioventricular nodal re-entrant tachycardia; 6 concealed accessory pathway ablations for atrioventricular re-entrant tachycardia; 17 focal ectopic atrial tachycardia ablations; 13 with only one arrhythmogenic pulmonary vein. No recurrences of SVT were observed during the follow-up (32 ± 18 months). 4 patients (8.5%) showed recurrence of at least one episode of AF. Patients with inducible SVT had less structural heart disease and were younger than those without inducible SVT. Conclusion: A significant proportion of candidates for AF ablation are inducible for an SVT. SVT ablation showed a preventive effect on AF recurrences. Those patients should be selected for simpler ablation procedures tailored only to the triggering arrhythmia suppression.

A Novel Endovascular Robotic System for Treatment of Lower Extremity Peripheral Arterial Disease: First-in-Human Experience.

BACKGROUND: To assess the feasibility and first-in-human experience of a novel endovascular robotic system for treatment of lower extremity peripheral arterial disease (PAD). METHODS: Between November 2021 and January 2022, consecutive patients with obstructive lower extremity PAD and claudication (Rutherford 2-5) with >50% stenosis demonstrated on angiography were enrolled in this study. Lower extremity peripheral arterial intervention was performed using the endovascular robotic system, which consisted of a bedside unit and an interventional console. The primary endpoints were technical success, defined as the successful manipulation of the lower extremity peripheral arterial devices using the robotic system, and safety. The secondary endpoints were clinical success, defined as 50% residual stenosis at the completion of the robot-assisted procedure without major adverse cardiac events and radiation exposure. RESULTS: In total, 5 patients with PAD were enrolled in this study (69.2±6.0 years; 80% men). The novel endovascular robotic system successfully completed the entire procedure of endovascular treatment of lower extremity PAD. Conversion to manual operation, including advancement, retracement, rotation of the guidewires, catheters, sheaths, deployment, and release of the balloons and stent grafts, was not necessary. We achieved the criteria for clinical procedural and technical success in all patients. No deaths, myocardial infarctions, or ruptures occurred in the period up to 30 days after the procedure, and no device-related complications were observed. The robotic system operator had 97.6% less radiation exposure than that at the procedure table, with a mean of 1.40±0.49 µGy. CONCLUSIONS: This study demonstrated the safety and feasibility of the robotic system. The procedure reached technical and clinical performance metrics and resulted in significantly lower radiation exposure to the operators at the console compared with that at the procedure table. CLINICAL IMPACT: There were some reports about several robotic systems used in the peripheral arterial disease, but no robotic system was able to perform entire procedure of endovascular treatment of lower extremity peripheral arterial disease (PAD).To solve this problem, we designed a remote-control novel endovascular robotic system. It was the first robotic system that can perform entire procedure of endovascular treatment of PAD worldwide. A novelty retrieval report about this is provided in the supplementary materials.The robotic system is compatible with all commercial endovascular surgical devices currently available in the market, including guidewires, catheters and stent delivery systems. It can perform all types of motion, such as forward, backward, and rotation to meet the requirements of all types of endovascular procedures. During the operation, the robotic system can perform these operations in a fine-tuned manner, so it is easy to cross the lesions, which is the key factor influencing the success rate of the operation. In addition, the robotic system can effectively reduce the exposure time to radiation, thereby reducing the risk of occupational injury.

Role of perfusion index and plethysmography variability index for predicting outcomes in neonatal sepsis.

AIM: (i) To compare perfusion index (PI) and plethysmography variability index (PVI) between neonates with proven or probable sepsis versus no-sepsis, (ii) to examine an association of PI and PVI with in-hospital mortality. METHODS: We enrolled neonates with clinically presumed sepsis. Culture-proven or probable sepsis were categorised as 'cases' and no-sepsis as 'controls'. PI and PVI were recorded hourly for 120 h and averaged in 20-time epochs (0-6 h to 115-120 h). RESULTS: We analysed 148 neonates with sepsis (proven sepsis = 77, probable sepsis = 71) and 126 with no-sepsis. Neonates with proven/probable sepsis and no-sepsis had comparable PI and PVI values. Among 148 neonates with sepsis, 43 (29%) died. Non-survivors had significantly lower PI values than survivors (mean difference 0.21 [95% CI 0.14-0.29], p-value <0.001). PI had a significant but modest discriminative ability to identify non-survivors. However, PI did not independently predict mortality. CONCLUSION: Neonates with proven/probable sepsis and no-sepsis had comparable PI and PVI values in the first 120 h of sepsis. PI but not PVI values were significantly lower in non-survivors than survivors. PI did not independently predict in-hospital mortality. Due to modest discriminative ability, PI should be interpreted along with other vital signs to take clinical decisions.