Early outcomes of experience warm surgery in children undergoing complete repair of tetralogy of Fallot in developing countries.

OBJECTIVES: While significant evidence supports the benefits of normothermic cardiopulmonary bypass (NCPB) over hypothermic techniques, many institutions in developing countries, including ours, continue to employ hypothermic methods. This study aimed to assess the early postoperative outcomes of normothermic cardiopulmonary bypass (NCPB) for complete surgical repair via the Tetralogy of Fallot (TOF) within our national context. METHODS: We conducted this study in the Pediatric Cardiac Intensive Care Unit (PCICU) at the University Children's Hospital. One hundred patients who underwent complete TOF repair were enrolled and categorized into two groups: the normothermic group (n = 50, temperature 35-37 °C) and the moderate hypothermic group (n = 50, temperature 28-32 °C). We evaluated mortality, morbidity, and postoperative complications in the PCICU as outcome measures. RESULTS: The demographic characteristics were similar between the two groups. However, the cardiopulmonary bypass (CPB) time and aortic cross-clamp (ACC) time were notably longer in the hypothermic group. The study recorded seven deaths, yielding an overall mortality rate of 7%. No significant differences were observed between the two groups concerning mortality, morbidity, or postoperative complications in the PCICU. CONCLUSIONS: Our findings suggest that normothermic procedures, while not demonstrably effective, are safe for pediatric cardiac surgery. Further research is warranted to substantiate and endorse the adoption of this technique.

Registration of finger implants in the Dutch arthroplasty registry (LROI).

Finger arthroplasty is commonly used to treat pain in the finger joints due to osteoarthritis or rheumatoid arthritis. Despite the procedure having existed for a relatively long time, it is still unknown which characteristics influence implant survival. The Dutch Arthroplasty Registry (LROI) is one of the 4 registries worldwide registering finger arthroplasties. This study aimed to investigate impact factors for implant survival regarding finger joint arthroplasty and assess registration completeness using the national healthcare claims database to compare. A total of 951 primary arthroplasties and 84 revision arthroplasties of the finger joints were registered. A higher likelihood of primary and revision surgery was found in female patients. The third and fourth proximal interphalangeal (PIP) joints were the most frequently operated in primary surgery; however, the metacarpophalangeal (MCP) joints were the most frequently revised joints. Silicone implants were used in most cases and evenly throughout all digits. Suboptimal registration completeness was shown for plastic surgeons with just 35.5%-37.4% of all surgeries registered. Although orthopedic surgeons do not perform most surgeries on the hand, they registered 76.5%-78.2% of surgeries. No statistical analyses were justified, considering the low completeness and limited follow-up. Female gender and PIP joint disease are possible risk factors for primary arthroplasty. MCP arthroplasties showed higher revision rates. However, participation rates and, therefore, data completeness were not optimal. To optimize participation, improving ease of registration should be explored. Furthermore, we urge readers who deal with joint implants to register their surgeries in the LROI database because only optimal registration completeness leads to high-quality data.

Prognostic risk factors for early outcomes of patients with myelomeningocele: a prospective study.

INTRODUCTION: Myelomeningocele (MMC) is a prevalent form of neural tube defect. Despite advancements in treatment, MMC still poses significant health risks, including complications leading to chronic disability and mortality. Identifying prognostic risk factors for early outcomes is crucial for tailored intervention strategies. METHODS: This prospective study involved newborns and infants diagnosed with MMC who underwent surgery between 2020 and 2023 at Urmia University of Medical Sciences. Demographic data and surgical outcomes were collected, and participants were followed up for six months. Statistical analyses were conducted using descriptive statistics, Chi-Square, and independent t-test. RESULTS: The study included 29 MMC cases, with an incidence rate of 1.4 per 10,000 live births. Lesions were predominantly located in the lumbar spine. Although mortality rates appeared to increase with ascending lesion sites, this trend was not statistically significant. Short-term outcomes revealed high morbidity and mortality rates, with neurological deficits being the most prevalent complication. Multivariable analysis identified head circumference as a significant predictor of adverse outcomes (IRR = 1.37, 95% CI = 1.02 to 1.86, p = 0.04). Furthermore, an increase in birth weight was associated with a reduction in the incidence of requiring a ventriculoperitoneal shunt (IRR = 0.99, 95% CI = 0.998 to 0.999, p = 0.02). CONCLUSION: This prospective study highlights prognostic risk factors for early outcomes in MMC patients, emphasizing the need for personalized intervention strategies. By addressing modifiable risk factors and implementing targeted interventions, healthcare providers can strive to improve outcomes and enhance the quality of life for MMC patients.

How Effective Is Phage Therapy for Prosthetic Joint Infections? A Preliminary Systematic Review and Proportional Meta-Analysis of Early Outcomes.

Background and Objectives: Despite the promise of phage therapy (PT), its efficacy in prosthetic joint infection (PJI) management is unknown. Much of the current literature is largely limited to case reports and series. Materials and Methods: In order to help inform power calculations for future clinical trials and comparative analyses, we performed a systematic review and proportional meta-analysis of early PT outcomes to provide a preliminary assessment of early phage therapy treatment outcomes for cases of PJI. Results: In a search of available literature across MEDLINE (Ovid, Wolters Kluwer, Alphen aan den Rijn, The Netherlands), Embase (Elsevier, Amsterdam, The Netherlands), the Web of Science Core Collection (Clarivate, London, UK), and Cochrane Central (Wiley, Hoboken, NJ, USA) up to 23 September 2023, we identified 37 patients with PJIs receiving adjunctive PT. Patients most frequently reported Staphylococcal species infection (95%) and intraarticular phage delivery (73%). Phage cocktail (65%) and antibiotic co-administration (97%) were common. A random-effects proportional meta-analysis suggested infection remission in 78% of patients (95% CI: 39%, 95%) (I2 = 55%, p = 0.08) and 83% with a minimum 12-month follow-up (95% CI: 53%, 95%) (I2 = 26%, p = 0.26). Conclusions: Our study provides a preliminary estimate of PT's efficacy in PJIs and informs future comparative studies.

Improved patient reported outcomes with the direct anterior approach versus the posterior approach for total hip arthroplasty in the early post-operative period.

BACKGROUND: Patients undergoing total hip arthroplasty (THA) with the direct anterior approach (DAA) may experience faster recovery but may also have better baseline health than those who undergo THA with the posterior approach (PA). This study aimed to compare patient-reported outcome measures (PROMs) between the DAA and PA while controlling for baseline factors. METHODS: This is a secondary data analysis from a prospective cohort study of patients utilizing a smartphone-based care management platform following THA. The primary outcomes were HOOS JR and EQ-5D-5L through 1 year and change from baseline. Longitudinal regression models were created to control for baseline characteristics and investigate the impact of surgical approach on PROMs. RESULTS: Of 1364 THAs evaluated, 731 (53.6%) were female, and 840 (61.6%) used the PA. Patients in the PA group were of similar age but had higher body mass index and comorbidity scores. Pre-operative HOOS JR and EQ-5D-5L were comparable, but higher post-operatively in the DAA group through 6 months (p = 0.03 and p = 0.005). At 1 year post-operatively, HOOS JR and EQ-5D-5L did not vary between groups (p = 0.48 and p = 0.56), nor did changes from baseline (p = 0.47 and p = 0.11). After controlling baseline characteristics, DAA was significantly associated with higher average HOOS JR through 6 months (p = 0.03) and EQ-5D-5L through 3 months (p = 0.005), but not at 12 months (p = 0.89 and p = 0.56). CONCLUSION: THA patients undergoing DAA demonstrate earlier improvements in HOOS JR and EQ-5D-5L. However, these differences may not be clinically significant and are not evident at 1-year post-operative. Patient selection and surgeon training may continue to affect outcomes by surgical approach.

Prevalence, factors and early outcomes of frailty among hospitalized older patients with valvular heart disease: A prospective observational cohort study.

AIM: The aim was to investigate the prevalence of, and factors related to frailty, together with early clinical outcomes, in hospitalized older patients with valvular heart disease (VHD) in China. DESIGN: A prospective observational cohort study was conducted. METHODS: A validated prospective survey was conducted to assess the prevalence of frailty, factors associated with it, and early clinical outcomes in hospitalized older patients with VHD, utilizing Fried's criterion. A total of 207 consecutive participants aged 65 years and older who underwent cardiac surgery were included in the study, spanning from September 2021 to December 2021. RESULTS: Frailty was detected in 78 patients (37.7%). Patients with multimorbidity, a New York Heart Association (NYHA) class of III/IV, or masticatory dysfunction had a greater incidence of frailty (p < 0.05). Patients with a normal albumin level and a higher frequency of exercise had a lower incidence of frailty (p < 0.05). Patients with frailty had longer hospital and intensive care unit stays and greater hospitalization costs than did those without frailty (p < 0.05). The 30-day adverse event rate of the frail group was also greater (11.5% vs. 3.1%). Therefore, early screening for conditions such as multimorbidity, cardiac dysfunction, and hypoalbuminemia is urgently needed to effectively address frailty, as it has been linked to unfavourable early outcomes. Moreover, promoting exercise and improving masticatory function and nutrition are crucial for preventing and managing frailty in older patients with VHD.

Group sequential designs for pragmatic clinical trials with early outcomes: methods and guidance for planning and implementation.

BACKGROUND: Group sequential designs are one of the most widely used methodologies for adaptive design in randomized clinical trials. In settings where early outcomes are available, they offer large gains in efficiency compared to a fixed design. However, such designs are underused and used predominantly in therapeutic areas where there is expertise and experience in implementation. One barrier to their greater use is the requirement to undertake simulation studies at the planning stage that require considerable knowledge, coding experience and additional costs. Based on some modest assumptions about the likely patterns of recruitment and the covariance structure of the outcomes, some simple analytic expressions are presented that negate the need to undertake simulations. METHODS: A model for longitudinal outcomes with an assumed approximate multivariate normal distribution and three contrasting simple recruitment models are described, based on fixed, increasing and decreasing rates. For assumed uniform and exponential correlation models, analytic expressions for the variance of the treatment effect and the effects of the early outcomes on reducing this variance at the primary outcome time-point are presented. Expressions for the minimum and maximum values show how the correlations and timing of the early outcomes affect design efficiency. RESULTS: Simulations showed how patterns of information accrual varied between correlation and recruitment models, and consequentially to some general guidance for planning a trial. Using a previously reported group sequential trial as an exemplar, it is shown how the analytic expressions given here could have been used as a quick and flexible planning tool, avoiding the need for extensive simulation studies based on individual participant data. CONCLUSIONS: The analytic expressions described can be routinely used at the planning stage of a putative trial, based on some modest assumptions about the likely number of outcomes and when they might occur and the expected recruitment patterns. Numerical simulations showed that these models behaved sensibly and allowed a range of design options to be explored in a way that would have been difficult and time-consuming if the previously described method of simulating individual trial participant data had been used.

Early outcomes of single-site versus multi-port robotic-assisted radical prostatectomy: A systematic review and meta-analysis.

BACKGROUND: Single-site robotic-assisted radical prostatectomy (ssRARP) has been promoted in many institutions due to its minimally invasive approach. This review aimed to investigate early outcomes of ssRARP in comparison with multi-port robotic-assisted radical prostatectomy (mpRARP). METHODS: A systematic literature search was performed for articles related to ssRARP case series and studies that compared ssRARP with mpRARP. The primary outcomes were functional and oncological outcomes, incision length, length of hospital stay and cost. RESULTS: 24 ssRARP case series involving 1385 cases, and 11 comparative studies involving 573 ssRARP cases and 980 mpRARP cases were included. Rate of immediate, 3-month, 6-month and 12-month recovery of continence in the ssRARP case series were 41 % [95 % CI: 0.38-0.45], 70 % [95 % CI: 0.67-0.73], 90 % [95 % CI: 0.87-0.93] and 93 % [95 % CI: 0.90-0.96]. 3-month potency recovery and positive surgical margin rate were 53 % [95 % CI: 0.46-0.60] and 21 % [95 % CI: 0.19-0.24]. No significant differences were detected between ssRARP and mpRARP in terms of 3-month (OR: 1.12; 95 % CI: 0.80-1.57) or 6-month (OR: 0.72; 95 % CI: 0.36-1.46) continence recovery rate, 3-month potency recovery rate (OR: 0.92; 95 % CI: 0.50-1.70), positive surgical margin rate (OR: 0.83; 95 % CI: 0.62-1.11), biochemical recurrence rate or total cost. Furthermore, ssRARP was associated with a significantly shorter length of incision and hospital stay. CONCLUSION: ssRARP has significant advantages in cosmetic effect, length of incision and rapid recovery. Consequently, ssRARP is expected to become the preferred form although more evidence is needed to determine its long-term effect.

The influence of mental health on early outcomes following total hip arthroplasty.

BACKGROUND: Poor mental health is difficult to recognize and as a result, its association with recovery from total joint arthroplasty is difficult to assess. The purpose of this study was to investigate the relationship between overall mental health scores and outcomes in the early postoperative period following unilateral total hip arthroplasty (THA). METHODS: This is a retrospective review of prospectively collected data involving 142 patients who underwent primary unilateral THA. Independent variables included patient demographics and preoperative Patient-Reported Outcomes Measurement Information System (PROMIS), Global Physical Health (GPH) and Global Mental Health (GMH) and Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS JR) scores as well as diagnoses of depression or anxiety. Dependent variables included length of stay (LOS), disposition at discharge, narcotic consumption until discharge, 6-week postoperative GPH, GMH and HOOS JR scores and magnitude of change compared to preoperative scores. Preoperative GMH and postoperative outcomes were compared using Pearson correlation coefficient, independent t-tests, Pearson's Chi-Square test, and univariate logistic regression. RESULTS: Patients with preoperative GMH scores below the 25% quartile were less likely to be discharged home and resulted in lower GPH, GMH and HOOS JR scores at 6-week follow-up compared to patients with preoperative GMH scores in the top 25% quartile. However, patients with low preoperative GMH scores demonstrated a greater magnitude of improvement in both the GPH and GMH scores compared to patients in the top 25% quartile. There was no difference in opioid consumption or LOS between either groups. When comparing patients with and without depression/anxiety, no difference was seen in any of the outcomes measured. CONCLUSION: Unilateral THA offers significant improvements in both physical and mental function to patients with hip osteoarthritis and poor mental health, though overall scores remain lower than in those with better mental health.

Early outcomes of open anterior versus posterior components separation with transversus abdominis release for large median incisional hernias: a retrospective stepwise analysis.

BACKGROUND: Complex incisional hernia is still a debatable topic, with increasing incidence and an increased local and systemic postoperative morbidity and mortality. The size of the defect is a risk factor for both difficult closure and 30-day readmission due to complications. The main option for closure such defect is a mesh augmented component separation technique. The goal was to evaluate 30-day wound events and general complications including 90 days mortality. MATERIAL AND METHODS: We present a retrospective study that includes patients from two different university hospitals who underwent open incisional hernia repair with anterior component or posterior component separation between January 2015 and December 2021. Only non-contaminated adult patients (over 18 years old) with postoperative primary or recurrent median abdominal wall defects larger than 6 cm and with complete fascial closure were included. Demographics (age, gender, Body Mass Index-BMI, American Society of Anesthesiologists Classification-ASA score), recurrence rank, and co-morbidities), operative details, patient outcomes complications were collected. A native abdomen/pelvis computerized tomography (CT) scan was performed preoperatively in all patients and the anatomy of the defect and volumetry (abdominal cavity volume, incisional hernia volume and peritoneal volume) were evaluated. One of the component separation technique was performed according to Carbonell's equation. RESULTS: Two hundred and two patients (101 from each group) were included. The patients with posterior component separation were more comorbid and with larger defects. The procedure was longer with 80 min but overall length of hospital stay shorter (p < 0.001) for posterior component separation. Seroma, hematoma and skin necrosis were equally distributed for both group of patients and there was no direct relation to surgery (OR 0.887, 95% CI 0.370-2.125, p = 0.788; OR 1.50, 95% CI 0.677-3.33, p = 0.318 and OR 0.386, 95% CI 0.117-1.276, p = 0.119). Surgical Site Infection rate was increased for anterior component separation (p =0.004). CONCLUSION: Complex incisional hernia repair is a challenge given by a large amount of wound complications. Choosing between anterior and posterior component separation is still a source of significant debate. We were not able to depict significant different rates of complications between the procedures and we couldn't find any specific factor related to complications.

Non-selective Del Nido and St Thomas cardioplegia in adults: analysis of early clinical experience using propensity matching.

BACKGROUND: Del Nido cardioplegia (DNC) is a single-dose, high potassium, low-volume cardioplegia solution that has grown in favor recently. However, the use of DNC in the Asian population may be associated with certain challenges. METHODS: Between January 2017 and April 2022, DNC was used for myocardial protection in this single-center retrospective study. In total, 5731 patients underwent open heart surgeries, where 310 patients received DNC for single or multiple procedures. A total of 307 pair of propensity-matched patients from DNC and cold blood St. Thomas cardioplegia (STC) were compared. RESULTS: In total, 5085 patients with STC and 310 patients with DNC from the cohort were matched, reflecting the initial group sizes before propensity matching. About 307 patient pairs were included in the final analysis after propensity matching with the interest variables. In the STC group, the requirement for an immediate postoperative intra-aortic balloon pump (IABP) was significantly higher [18 (5.9%) in DNC versus 28 (9.1%) in STC, p = 0.021]. A 30-day mortality was comparable between the DNC and STC groups (2.9% versus 3.3%, p = 1.00). Major adverse cardiac events (MACE) (2.6% versus 3.6%, p = 0.648) showed no difference between the groups. In both single and multiple procedure subgroups, there were no statistically significant differences in 30-day mortality and MACE incidences when comparing STC and DNC. CONCLUSION: The use of DNC in adults is acceptable and adaptable. Comparable clinical outcomes between STC patients and DNC were revealed by our investigation. There were no appreciable differences in 30-day mortality or MACE despite the STC group having a much higher need for immediate postoperative IABP.

Early Outcomes on Triple-Branch Arch Device With Retrograde Left Common Carotid Branch: A Case Series.

INTRODUCTION: Endovascular aortic arch repair using multibranch devices has been applied in patients considered at high risk for open repair. The aim of this case series was to report the early outcomes in patients managed with a new design 3 branch arch custom-made device, including a retrograde left common carotid artery (LCCA) branch. METHODS: The Preferred Reporting Of CaSe Series in Surgery (PROCESS) guidelines were followed. All consecutive patients undergoing endovascular repair of an aortic arch lesion with a custom-made triple-branch device, including a retrograde LCCA branch (Cook Medical, Bloomington, IN, USA), between October 27, 2022, and February 28, 2023, were included. The presence of an arch aneurysm (degenerative or post-dissection) with diameter ≥55 mm and high risk for a conventional open repair set the indication for treatment. The primary outcomes were technical success and mortality at 30 days. Early morbidity and reinterventions were considered as secondary outcomes. RESULTS: Eight elective patients (87.5% men, mean age 72.3±27.0 years) were included. Five of them (62.5%) had undergone a previous ascending aorta repair of an acute type A aortic dissection. All patients were asymptomatic, except one, with left recurrent laryngeal nerve compression. The mean maximum aortic diameter was 70.4±21.0 mm. Percutaneous femoral and axillary access was used in all cases except three in which a cut down for right carotid access was performed. Technical success was 100%. Femoral access to the LCCA and implantation of the bridging stent was performed without technical challenges. No death nor cerebrovascular event was recorded during the 30 day follow-up. Five patients (62.5%) presented major complications, 3 related to access needing reintervention and the remaining related to congestive heart failure (CHF), which were managed successfully with medical treatment. Follow-up (range 1-4 month) was uneventful, except for one patient who presented a secondary type Ia endoleak. CONCLUSIONS: According to our early experience, the presence of a retrograde branch facilitated the revascularization of the LCCA through femoral access, decreasing the risk of cerebrovascular morbidity. Further analyses with longer follow-up are needed to evaluate the safety and efficacy of the device. CLINICAL IMPACT: Data arising mainly from the retrograde branch for the revascularization of the LSA are encouraging from a variety of devices. The premiminary experience with a triple-branched arch device, with a retrograde branche for the LSA but also for the LCCA, was associated with no 30 day mortality and 100% technical success.The device's design allowed swift catheterization and completion of the LCCA revascularization using femoral access exclusively.

Early Outcomes of Modified Technique of Mobile Bearing Unicondylar Knee Replacement.

Background: Recent years have seen a resurgence in utilization of partial knee replacement. One such device frequently used is Oxford partial knee implant (OPK). Deeper tibial bone cut while performing OPK replacement may risk early failure. Methods: We prospectively looked at early outcomes of a modified technique (MT) of OPK replacement adopted by our centre to save tibial bone stock at 24 months of follow up as compared to designer group described technique (DT) as a prospective cohort. Results: At 2 years follow up New Knee Society Score showed patient satisfaction (38.25 in DT vs 39.02 in MT, p value 0.10), objective (92.77 in DT vs 91.07 in MT, p value 0.21), expectation scores (14.77 in DT vs 14.85 in MT, p value 0.81) and activity (60.72 in DT vs 68.17 in MT, p value 0.79 were similar in MT group as compared to DT. The stair climbing ability (22.46 in MT vs 29.96 in DT, p value < 0.001) and getting up from chair (13.16 in MT vs 19.80 in DT, p value < 0.001), was better with MT group but most other patient performance scores were similar as assessed by DOP (Delaware Osteoarthritis Profile). Both groups had failure rate of 5% at 24 months follow up. Conclusion: MT resulted in similar early outcomes in terms of patient reported outcomes, satisfaction and performance as compared to DT group. The MT to save tibial bone stock did not compromise early outcomes and can be utilised in certain patients with higher risk of tibial failure.

Comparing high and low energy outcomes on day one for SmartSight myopic-astigmatism treatments with the SCHWIND ATOS: a retrospective case series.

BACKGROUND: Impact of low energy asymmetric spacings vs. high energy symmetric spacings on the immediate/early (postoperative day 1 (POD1)) outcomes of SmartSight lenticule extraction for myopic astigmatism with a new femtosecond laser system. METHODS: The first 112 eyes of 56 patients consecutively treated using low energy asymmetric spacings (Group A; Study group) were compared at POD1 to the last 112 eyes of 56 patients consecutively treated using high energy symmetric spacings (Group S; Controls). Mean age of the patients was 28 ± 5 years with a mean spherical equivalent of -4.41 ± 1.76 diopters (D) and a mean magnitude of refractive astigmatism of 0.89 ± 0.82 D. RESULTS: Laser Energy was -25 ± 1nJ lower for asymmetric treatments (p < .0001); Spot and Track distances were + 0.7 ± 0.1 µm larger and -0.8 ± 0.1 µm tighter for asymmetric treatments, respectively (p < .0001 for both). At POD1, astigmatism was -0.08 ± 0.02D lower for asymmetric treatments (p < .0003); uncorrected and corrected visual acuities (UDVA and CDVA, respectively) were -0.03 ± 0.01logMAR better for asymmetric treatments (p < .0007); differences between postop UDVA and preop CDVA along with change in CDVA were + 0.3 ± 0.1lines better for asymmetric treatments (p < .0003). CONCLUSIONS: Lenticule extraction treatment using SmartSight is safe and efficacious already at POD1. Findings suggest that low energy asymmetric spacings may further improve the immediate and short-term outcomes of SmartSight lenticule extraction in the treatment of myopic astigmatism compared to conventional settings (high energy symmetric spacings).

Re-ruptures and early outcomes after surgical repair of acute Achilles tendon ruptures: prospective, comparative multicenter study.

PURPOSE: The primary objective of this study was to compare the re-rupture rate, clinical results, and functional outcomes six months after the surgical repair of an acute Achilles tendon rupture between three different techniques (open repair, percutaneous repair with the Tenolig®, and minimally invasive repair). METHODS: A prospective, comparative, multicenter, non-randomized study was performed and included 111 patients who had an acute ruptured Achilles tendon: 74 underwent an open repair, 22 underwent a percutaneous repair using the Tenolig® and 15 had a minimally invasive repair. At six months follow-up we analyzed the number of re-ruptures, phlebitis, infections, complex regional pain syndrome, clinical outcomes (muscle atrophy, ankle dorsal flexion), functional scores (ATRS, VISA-A, EFAS, SF-12), and return to running. RESULTS: There were more re-ruptures (p=0.0001) after repair with the Tenolig® (27%) than with open repairs (1.3%) and minimally invasive repairs (0%). The rate of other complications was not different. No clinical differences were found between the three groups. Only some functional scores EFAS Total (p=0.006), and VISA-A (p=0.015) were worse in the Tenolig® group. All the other results were similar between the three groups. CONCLUSION: Despite heterogeneous studies in literature, the results of this comparative and prospective study between three surgical techniques of Achilles tendon repair confirmed that Tenolig® repair increased the rate of early re-rupture compared to open or minimally invasive techniques.

The perioperative outcomes of uniportal robotic-assisted thoracic surgeries-a systematic review and meta-analysis of surgical cohort studies and case reports.

Background: Early results have illustrated the multiportal robotic approach to be safe and oncologically efficacious in the treatment of thoracic malignancies. Industry leaders have improved upon the lessons learned during the early multiportal studies and have now come to establish the feasibility of the biportal, and subsequently the uniportal robotic-assisted approach, all in an effort to offer patients equivalent or better outcomes with less surgical trauma. No current, coherent body of evidence currently exists outlining the early-term outcomes of patients undergoing uniportal robotic-assisted thoracic surgery. This systematic review and meta-analysis sought to clarify the early-phase outcomes of these patients. Methods: An electronic search of four databases was performed to identify relevant studies outlining the immediate post-operative outcomes of patients undergoing uniportal robotic-assisted thoracic surgeries. The primary endpoint was defined as technical success (i.e., no conversion to secondary robotic, video-assisted thoracoscopic, or open approaches). Secondary endpoints of interest included post-operative outcomes and complication rates. A meta-analysis using a random effects model of proportions or means was applied, as appropriate. Results: The search strategy ultimately yielded 12 relevant studies for inclusion. A total of 240 patients (52% male) split across cohort studies and case reports were identified. The mean age of the two groups was 59.7±3.0 and 58.1±6.8 years, respectively. The mean operative time was 133.8±38.2 and 150.0±52.2 minutes, respectively. Length of hospital stay was 4.4±1.6 and 4.3±1.1 days, respectively. The mean blood loss was 80.0±25.1 mL The majority of identified procedures were lobectomies, segmentectomies, and wedge resections, though complex sleeve resections and anterior mediastinal mass resections were also completed. Cumulative technical success was 99.9%. Conclusions: The uniportal robotic-assisted approach, when completed in expert hands, has been illustrated to have exceedingly low rates of conversion to secondary procedures, along with short length of stay (LOS), minimal blood loss, and short procedural times (variable depending on operation type). Current evidence on the feasibility of this approach will be bolstered by upcoming multi-institutional series.

Early outcomes, associated factors and predictive values of clinical outcomes of tandospirone in generalized anxiety disorder: a post-hoc analysis of a randomized, controlled, multicenter clinical trial.

OBJECTIVE: To examine the early outcomes, associated factors and predictive values of clinical outcomes of different tandospirone doses in patients with a generalized anxiety disorder (GAD). METHODS: This was a posthoc analysis of "a randomized, controlled multicenter clinical trial of the efficacy and safety of different doses of tandospirone on GAD". A total of 274 patients with GAD were included and randomized into the high-dose (tandospirone 60 mg/d) and low-dose (tandospirone 30 mg/d) groups for a 6-week treatment. The Hamilton Anxiety (HAMA), Clinical Global Impression-Severity (CGI-S), Short-Form-12 (SF-12) scales were used for assessment. The trial was registered at clinical trail.gov (NCT01614041). RESULTS: (1) In the first week of treatment, 35.8% of patients in the high-dose group fulfilled the early onset criteria, which was significantly higher than 19.0% found in the low-dose group (p = 0.002). In the second week of treatment, 22.6% of patients in the high-dose group achieved an early response, versus 12.4% in the low-dose group, indicating a significant difference (p = .026). (2) Factors associated with early onset at week 1 included baseline HAMA total score (OR = 0.916, 95%CI 0.882-0.952), age (OR = 0.974, 95%CI 0.950-0.998), drug dose (30 mg vs. 60 mg; OR = 0.298, 95%CI 0.156-0.568) and SF-12 physiological total score (OR = 1.030, 95%CI 1.010-1.050). (3) Early onset was significantly associated with response rate (OR = 18.34, 95%CI 12.10-27.81), remarkable response rate (OR = 27.56, 95%CI 11.65-65.17) and recovery rate (OR = 11.85, 95%CI 4.98-28.18). Group (high dose group vs. low dose group) (χ2 = 8.535, p = .003) and baseline HAMA total score (χ2 = 70.840, p < .001) were independent predictors of onset time. CONCLUSIONS: The early outcomes of high-dose tandospirone in the treatment of GAD are better than those of the low-dose group. Patients with younger age at onset, milder anxiety symptoms and better physiological functions administered high-dose tandospirone showed rapid onset, great early outcomes, high recovery rate and good prognosis. Drug onset time had a good predictive effect on treatment outcome.

Interrupted versus continuous suture for bronchial anastomosis in lung transplantation: does it matter?

OBJECTIVES: Bronchial anastomotic complications remain a major concern in lung transplantation. We aim to compare 2 different techniques, continuous suture (CS) versus interrupted suture (IS) by analysing airway complications requiring intervention. METHODS: Lung transplantations between January 2015 and December 2020 were included. Airway complications requiring intervention were classified following the 2018 International Society for Heart and Lung Transplantation consensus and analysed comparing 3 groups of patients according to surgical technique: group A, both anastomosis performed with CS; group B, both with interrupted; and group C, IS for 1 side and CS for the contralateral side. RESULTS: A total of 461 anastomoses were performed in 245 patients. The incidence of airway complications requiring intervention was 5.7% [95% confidence interval (CI): 2.8-8.6] per patient (14/245) and 3.7% (95% CI: 2.0-5.4) per anastomosis (17/461). Complications that required intervention were present in 5 out of 164 (3.1%) anastomosis with interrupted technique, and in 12/240 (5%) with CS. No significant differences were found between techniques (P = 0.184). No statistical differences were found among group A, B or C in terms of incidence of anastomotic complications, demographics, transplant outcomes or overall survival (log-rank P = 0.513). In a multivariable analysis, right laterality was significantly associated to complications requiring intervention (OR 3.7 [95% CI: 1.1-12.3], P = 0.030). Endoscopic treatment was successful in 12 patients (85.7%). Retransplantation was necessary in 2 patients. CONCLUSIONS: In summary, although it seems that anastomotic complications requiring intervention occur more frequently with CS, there are no statistical differences compared to IS. Endoscopic treatment offers good outcomes in most of the airway complications after lung transplantation.

Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs.

BACKGROUND: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early. METHODS: Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT. RESULTS: The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up. CONCLUSIONS: The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly.

Endovascular repair of an intrathoracic subclavian artery aneurysm with a single-branched thoracic endograft in a hostile anatomy.

OBJECTIVE: Subclavian artery aneurysms (SAA) are rare and usually involve the proximal segment of the artery. In this setting traditional surgical treatment or hybrid procedures are associated with significative morbidity rate so that new endovascular solutions are preferred. METHODS: Authors report a case of a patient with an intrathoracic left SAA involving the aortic arch's outer curve. Patient's comorbidities contraindicated open surgical treatment while anatomical issues were not favourable to hybrid or standard endovascular solutions. Thus a single-branched custom-made thoracic stent-graft (Castor, MicroPort Medical, Shanghai, China) was implanted. RESULTS: Technical success was achieved with no intra-operative complications and technical steps of the procedure are accurately described.A pre-discharge CT scan showed the correct position of the endograft, complete aneurysm exclusion and branch patency. CONCLUSION: Single-branched thoracic stentgrafts could be a good option in unfavourable anatomies with supra-aortic vessels disease involving the aortic arch, with good results in terms of morbidity and early outcomes.