Robotic magnetic navigation-guided catheter ablation establishes highly effective pulmonary vein isolation in patients with paroxysmal atrial fibrillation when compared to conventional ablation techniques.

INTRODUCTION: Pulmonary vein isolation (PVI) is a pivotal part of ablative therapy for atrial fibrillation (AF). Currently, there are multiple techniques available to realize PVI, including: manual-guided cryoballoon (MAN-CB), manual-guided radiofrequency (MAN-RF), and robotic magnetic navigation-guided radiofrequency ablation (RMN-RF). There is a lack of large prospective trials comparing contemporary RMN-RF with the more conventional ablation techniques. This study prospectively compared three catheter ablation techniques as treatment of paroxysmal AF. METHODS: This multicenter, prospective study included patients with paroxysmal AF who underwent their first ablation procedure. Procedural parameters (including procedural efficiency), complication rates, and freedom of AF during 12-month follow-up, were compared between three study groups which were defined by the utilized ablation technique. RESULTS: A total of 221 patients were included in this study. Total procedure time was significantly shorter in MAN-CB (78 ± 21 min) compared to MAN-RF (115 ± 41 min; p < .001) and compared to RMN-RF (129 ± 32 min; p < .001), whereas it was comparable between the two radiofrequency (RF) groups (p = .062). A 3% complication rate was observed, which was comparable between all groups. At 12-month follow-up, AF recurrence was observed in 40 patients (19%) and was significantly lower in the robotic group (MAN-CB 19 [24%], MAN-RF 16 [23%], RMN-RF 5 [8%] AF recurrences, p = .045) (multivariate hazard ratio of RMN-RF on AF recurrence 0.32, 95% confidence interval: 0.12-0.87, p = .026). CONCLUSION: RMN-guided PVI results in high freedom of AF in patients with paroxysmal AF, when compared to cryoablation and manual RF ablation. Cryoablation remains the most time-efficient ablation technique, whereas RMN nowadays has comparable efficiency with manual RF ablation.

Effectiveness of the Fast Track Surgery Program for Patients with Planned Cholecystectomy.

PURPOSE: This study analyzed the effectiveness of minimizing surgical trauma, reducing the severity of the stress reaction, and restoring the normal functioning of the body after planned gallbladder operations under an enhanced recovery program. MATERIALS AND METHODS: This prospective comparison study included 30 patients from the surgical department of Irkutsk Clinical Hospital No. 1 who had been diagnosed with cholelithiasis in 2019-2020. All 30 patients completed the study and were randomly assigned to one of two groups: the FTS group (group I, n = 15) and the standard group (group II, n = 15). The comparison groups were statistically homogeneous in terms of preoperative parameters. All patients underwent prescribed surgeries. In the early and late postoperative period, there were no cases of mortality or significant complications. RESULTS: A comparison of the groups with respect to the effectiveness of treatment according to established criteria showed good treatment results for 13 (86.6%) patients in group I and 2 (13.3%) patients in group II (p = 0.016). The FTS treatment protocol was a significant predictor of treatment success (OR 3.1; 95% CI 0.2; 6.0; p = 0.033). CONCLUSION: The fast track surgery protocol gave superior results for surgical treatment in comparison with the standard protocol in patients with cholelithiasis.

Solubility Enhancement of Dihydroquercetin via "Green" Phase Modification.

Dihydroquercetin (DHQ) is a promising antioxidant for medical applications. The poor water solubility of this flavanonol at ambient conditions inhibits its implementation in clinical practice as an injectable dosage form. Thus, increasing water solubility is a critical step toward solving this problem. Herein we attempted to deal with this problem via DHQ phase modification while at the same time adhering to the principles of green chemistry as much as possible. Lyophilization is an appropriate method to achieve phase modification in an environment-friendly way. This method was employed to generate new phase modifications of DHQ that were then characterized. Mixtures of water with ethanol or acetonitrile were used as solvents for the preparation of the lyophilizates, DHQE, and DHQA, respectively. The results of dissolution testing of the obtained DHQE and DHQA demonstrated that the lyophilization increased water solubility at least 30-fold times. These new DHQ modifications were studied by scanning electron microscopy, mass-spectrometry, nuclear magnetic resonance spectroscopy, infrared spectroscopy, X-ray powder diffraction, and thermal analysis. Their solid-state phases were confirmed to differ from the initial DHQ substance without any changes in the molecular structure. Both DHQE and DHQA showed as high antioxidant activity as the initial DHQ. These data demonstrate the potential of DHQE and DHQA as active pharmaceutical ingredients for injectable dosage forms.

Urinary System Iatrogenic Injuries: Problem Review.

INTRODUCTION: From May to December 2019, a literature review of the urinary system iatrogenic injury problem was performed. The most cited, representative articles in PubMed, Scopus, and WoS databases dedicated to this problem were selected. Urinary system iatrogenic injuries include ureter, bladder, urethra, and kidney traumas. It is widely thought that the main causes of such injuries are urological, obstetric, gynecological, and surgical operations on the retroperitoneal space, pelvis, or perineum. METHODS: The purpose of the study is to describe all aspects of the iatrogenic injure problem, under the established scheme and for each of the most damaged organs: the urethra, bladder, kidney, and ureter. The treatment of confirmed iatrogenic injuries largely depends on the period of its detection. Modern medical procedures provide conservative or minimally invasive treatment. An untimely diagnosis worsens the treatment prognosis. "Overlooked" urinary system trauma is a serious threat to society and a particular patient. Thus, incorrect or traumatic catheterization can lead to infection (RR 95%) and urethral stricture (RR ≥11-36%), and percutaneous puncture nephrostomy can cause the risk of functional renal parenchyma loss (median 5%), urinary congestion (7%), or sepsis (0.6-1.5%). RESULTS: Lost gain, profits, long-term and expensive, possibly multistage treatment, stress and depression, and the risks of suicide put a heavy financial, moral, and ethical burden on a person and society. Also, iatrogenic injury might have legal consequences. DISCUSSION/CONCLUSION: Thus, the significant problem of urinary tract iatrogenic injuries is still difficult to solve. There is a need to implement mandatory examining algorithms for patients at risk, as well as the multidisciplinary principle for all pelvic surgery.

ABTS/PP Decolorization Assay of Antioxidant Capacity Reaction Pathways.

The 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) (ABTS•+) radical cation-based assays are among the most abundant antioxidant capacity assays, together with the 2,2-diphenyl-1-picrylhydrazyl (DPPH) radical-based assays according to the Scopus citation rates. The main objective of this review was to elucidate the reaction pathways that underlie the ABTS/potassium persulfate decolorization assay of antioxidant capacity. Comparative analysis of the literature data showed that there are two principal reaction pathways. Some antioxidants, at least of phenolic nature, can form coupling adducts with ABTS•+, whereas others can undergo oxidation without coupling, thus the coupling is a specific reaction for certain antioxidants. These coupling adducts can undergo further oxidative degradation, leading to hydrazindyilidene-like and/or imine-like adducts with 3-ethyl-2-oxo-1,3-benzothiazoline-6-sulfonate and 3-ethyl-2-imino-1,3-benzothiazoline-6-sulfonate as marker compounds, respectively. The extent to which the coupling reaction contributes to the total antioxidant capacity, as well as the specificity and relevance of oxidation products, requires further in-depth elucidation. Undoubtedly, there are questions as to the overall application of this assay and this review adds to them, as specific reactions such as coupling might bias a comparison between antioxidants. Nevertheless, ABTS-based assays can still be recommended with certain reservations, particularly for tracking changes in the same antioxidant system during storage and processing.

A New "Non-Traditional" Antibacterial Drug Fluorothiazinone-Clinical Research in Patients with Complicated Urinary Tract Infections.

In order to combat resistance, it is necessary to develop antimicrobial agents that act differently from conventional antibiotics. Fluorothiazinone, 300 mg tablet (The Gamaleya National Research Center), is an original antibacterial drug based on a new small molecule T3SS and flagellum inhibitor. A total of 357 patients with complicated urinary tract infections (UTIs) were divided into two groups and given Fluorothiazinone 1200 mg/day or a placebo for 7 days to evaluate the efficacy and safety of the drug. Additionally, all patients were given Cefepime 2000 mg/day. Fluorothiazinone with Cefepime showed superiority over placebo/Cefepime based on the assessment of the proportion of patients with an overall outcome in the form of a cure after 21 days post-therapy (primary outcome), overall outcome in cure rates, clinical cure rates, and microbiological efficacy at the end of therapy and after 21 days post-therapy (secondary outcomes). In patients who received Fluorothiazinone, the rate of infection recurrences 53 and 83 days after the end of the therapy was lower by 18.9%, compared with patients who received placebo. Fluorothiazinone demonstrated a favorable safety profile with no serious unexpected adverse events reported. The results showed superiority of the therapy with Fluorothiazinone in combination with Cefepime compared with placebo/Cefepime in patients with cUTIs.

The effectiveness of penile curvature treatment by cavernous body rotation and plication of the tunica albuginea.

BACKGROUND: There are several approaches to the surgical treatment of the penile curvature conditionally divided into three large groups: tunica albuginea plication (TAP), corpus cavernosum rotation (CR), and transplantation of various materials. The study aims to compare the effectiveness of TAP and CR techniques in the treatment of penile curvature. There was a prospective randomized study of the effectiveness of surgical treatment of patients with an established diagnosis of the penile curvature from 2017 to 2020 in Irkutsk, Russian Federation. The final analysis of the results included 22 cases. RESULTS: The analysis of the comparative intergroup effectiveness of the treatment performed based on the criteria established in the study showed good treatment results in 8 (88.8%) patients in the CR group and 9 (69.2%) patients in the TAP group (p = 0.577). The other patients obtained satisfactory results. There were no negative outcomes. Simple logistic regression analysis showed that the preoperative flexion angle > 60 degrees (OR 2.7; 95% CI 0.12; 5.28; p = 0.040) was significant in predicting the complaints of penile shortening during TAP. Both methods are safe, effective, and bring minimal risk of complications. CONCLUSION: Thus, the effectiveness of both treatment methods is comparable. However, TAP surgery is not recommended for patients with an initial curvature of more than 60 degrees.

RéSUMé: CONTEXTE: Il existe plusieurs approches du traitement chirurgical de la courbure pénienne, divisées en trois grands groupes : plicature de la tunique albuginée (PTA), rotation du corps caverneux (RCC) et transplantation de divers matériaux. La présente étude vise à comparer l'efficacité des techniques PTA et RCC dans le traitement de la courbure du pénis. Il s'agit d'une étude prospective randomisée de l'efficacité du traitement chirurgical de patients ayant un diagnostic établi de courbure du pénis, de 2017 à 2020 à Irkoutsk, en Fédération de Russie. L'analyse finale des résultats comprend 22 cas. RéSULTATS: L'analyse de l'efficacité comparative intergroupe du traitement effectué sur la base des critères établis dans l'étude, a montré de bons résultats du traitement chez 8 (88,8%) patients du groupe RCC et 9 (69,2%) patients du groupe PTA (p = 0,577). Les autres patients ont obtenu des résultats satisfaisants. Il n'y a eu aucun résultat négatif. Une analyse de régression logistique simple a montré qu'un angle de flexion préopératoire > 60 degrés (OR 2,7 ; IC à 95 % 0,12 ; 5,28 ; p = 0,040) était significatif pour prédire les plaintes de raccourcissement du pénis avec l'approche de la PTA. Les deux méthodes sont sûres, efficaces et présentent un risque minimal de complications. CONCLUSIONS: Ainsi, l'efficacité des deux méthodes de traitement est comparable. Cependant, la chirurgie avec l'approche de la PTA n'est pas recommandée chez les patients ayant une courbure initiale de plus de 60 degrés.

Fast Track Surgery as the Latest Multimodal Strategy of Enhanced Recovery after Urethroplasty.

Fast track surgery (FTS), as well as ERAS (enhanced recovery after surgery/rapid recovery programs), is the latest multimodal treatment strategy, designed to reduce the disability period and improve the medical care quality. The study aims to analyze the enhanced recovery protocol effectiveness in a comparative study of elective urethral stricture surgery. A prospective study included 54 patients with an established diagnosis of urethral stricture in 2019-2020 in the urological hospital of the Irkutsk City Clinical Hospital No. 1. All 54 patients have completed the study. There were two groups of patients FTS-group (group II, n = 25) and standard group (group I, n = 29). In terms of preoperative parameters, the comparison groups have statistical homogeneity. The comparative intergroup efficacy analysis of the treatment based on the criteria established in the study demonstrated good treatment results for 5 (17.2%) patients of group I and 20 (80%) patients of group II (p=0.004). The overall efficacy of urethroplasty surgeries, regardless of the treatment protocol, was comparable (86.2% vs 92%; p=0.870), as well as the likelihood of relapse within two years (p=0.512). The predictors of recurrence were technical complications and urethral suture failure (OR 4.36; 95% CI 1.6; 7.11; p=0.002). The FTS protocol reduced the treatment period (p < 0.001) and decreased the severity of postoperative pain (p < 0.001). The use of the "fast track surgery" protocol in urethroplasty with generally similar treatment results makes it possible to achieve a better functional and objective condition of patients in the postoperative period due to less pain, shorter catheterization, and hospitalization.

Enhanced recovery after retrograde intra-renal surgery (RIRS) in comparison with mini-percutaneous nephrolithotomy (Mini-PCNL) for renal stone treatment.

OBJECTIVES: The study presents a comparative analysis of the mini-percutaneous nephrolithotripsy (mini-PCNL) and retrograde nephrolithotripsy (RIRS) with a logistic analysis of outcomes and complications. MATERIAL AND METHODS: The prospective study included 50 patients diagnosed with urolithiasis from 2018 to 2021 in the urological hospitals in Irkutsk. Patients were divided into two groups: RIRS (group I, n = 23) and Mini-PCNL (group II, n = 27). The comparison groups are statistically homogeneous. RESULTS: Both procedures equally lead to high stone free rates (SFR > 1 mm, 91.3% vs 85.1%; p = 0.867; SFR > 2 mm, 95.6% vs 92.5%; p = 0.936). The intergroup analysis of the total operation time (and lithotripsy) demonstrated similar times (p > 0.05). Postoperative complications of classes II-III (Clavien-Dindo) in the early and late postoperative period developed rarely and were comparable (p > 0.05). Class I complications were predominant in the PCNL group (p = 0.007). Some parameters demonstrated the superiority of RIRS over PCNL: less pronounced pain syndrome (p = 0.002), less drainage time (p < 0.001), no postoperative hematuria (p = 0.002), shorter hospitalization and total treatment period (p < 0.001). CONCLUSIONS: The study highlighted the positive effect of the oneday surgery principle on the risk of developing postoperative hematuria, urinary infection, or severe postoperative pain. RIRS and mini-PCNL have similar effectiveness, but RIRS meets the criteria of the enhanced recovery program more than PCNL.

Comparison of efficiency of vascular-preserving urethroplastic methods of the bulbo-membranous part of the urethra.

INTRODUCTION: There are several options for vessel-sparing anastomotic procedures that allow one to avoid disturbances in the normal blood supply to the spongy body and successfully perform plastic surgery of distal urethral strictures. AIM: To perform a comparative analysis of the effectiveness of reconstructive surgical treatment of strictures of the bulbo-membranous urethra with anastomotic surgery with and without vessel-sparing. MATERIAL AND METHODS: A prospective study was carried out on 28 patients with a diagnosis of stricture of the bulbo-membranous urethra who underwent treatment in the period 2012-2018 in the conditions of a urological hospital of Irkutsk City Clinical Hospital No. 1. Anastomotic urethroplasty was performed using one of two methods: with full mobilization of the spongy body bulb and a vessel-sparing method when the spongy body does not intersect. RESULTS: The effectiveness of the classical method of anastomosing EPA-TWW ((excision and primary anastomosis urethroplasty (Turner-Warwick) and excision and Jordan's technique of vessel sparing excision and primary anastomosis)) was comparable with the method of anastomosing without crossing the (spongy body of EPA-J). Postoperative changes in the parameters of the functional status of patients based on the International Prostate Symptom Score (IPSS), International Index of Erectile Function, and Quality of Life were comparable in patients undergoing EPA-TWW and EPA-J. The final data indicate a statistically equivalent risk of developing complications such as urinary incontinence, shortening of the penis, and decreased erectile function. CONCLUSIONS: The study did not demonstrate a statistically significant difference in the effectiveness of the treatment and the risks of complications during anastomotic surgery with or without vessel-sparing. However, an unformalized assessment demonstrates the best state of erectile function in patients after vascular-preserving surgery.

Efficacy Evaluation of a Case-Specific Approach for Surgical Treatment of Inicisional Ventral Hernia.

BACKGROUND: The research aims to improve the surgical treatment results of incisional ventral hernia by applying a case-specific approach and a new method of anterior abdominal wall surgery. MATERIALS AND METHODS: The paper reports the results of the prospective dynamic cohort study on 219 patients under 60 years of age, with small and medium hernias and up to 10 cm defects in the anterior abdominal wall (W1-W2), who underwent incisional ventral hernia treatment with mesh endoprostheses. RESULTS: The paper offers a selection algorithm for anterior abdominal wall repair surgery and an original proprietary technique. We have developed and described in detail a new 'extra-sublay' technique of surgical intervention. The paper displays the frequency and pattern of complications, as well as the quality of life of patients after different prosthetic surgeries. In the main group, 65.0% of patients showed improvement, 88.4% showed long-term surgical success, 13.6% faced complications, and 4.5% experienced recurrence. CONCLUSION: After receiving the "on lay" treatment, 59.4% of patients showed positive results, 74.7% showed long-term surgical success, 40% had complications, and 3.1% experienced recurrence. After the "sub lay" intervention, 40.0% of patients demonstrated excellent results, 81.9% reached long-term success, 12% had complications, and 1.4% encountered recurrence. HIGHLIGHTS: The article shows a selection algorithm for anterior abdominal wall plastic repair method.One of the factors that cause relapses and ventral hernias themselves is obesity.The authors' method of the VH surgical treatment has shown good results.Excellent indicators showed 65.0% of patients of the main group.

Efficacy evaluation of case-specific approach for surgical treatment of incisional ventral hernia.

<b>Aim:</b> The aim of this research is to improve the results of surgical treatment of incisional ventral hernia by applying a case-specific approach and a new method of plastic repair of the anterior abdominal wall.<br/> <br/> <b>Methods:<b/> The prospective controlled dynamic study is based on incisional ventral hernia treatment results with the use of meshed endoprostheses among 219 patients. On-lay alloplasty was used in patients younger than 60 years of age, without severe concomitant pathology, with small and medium hernias and anterior abdominal wall defect of up to 10 cm (W1-W2).<br/> <br/> <b>Results:<b/> The article shows a selection algorithm for anterior abdominal wall plastic repair method. It goes through advantages of the author's proprietary technique. The article displays frequency and patterns of complications, with life quality of the patients after various prosthetic plastic repairs. In the main group, positive treatment results were observed in 65.0%, longterm results of the operation were observed in 88.4%, complications occurred in 13.6%, relapse in 4.5%. «Onlay¼ treatment tactics showed positive results in 59.4%, long-term results of the operation were observed in 74.7%, complications occurred in 40%, relapse in 3.1%. After «sublay¼ intervention, excellent results were observed in 40.0% of patients, long-term results of the operation were observed in 81.9%, complications occurred in 12%, and relapse in 1.4%<br/> <br/>.

Buccal mucosal graft urethroplasty of the bulbomembranous part of urethra.

INTRODUCTION: Urethral stricture is a partial or complete narrowing of the urethra, caused by damage to the urethral epithelium. This disease leads to a persistent urination dysfunction, the elimination of which is a difficult task. The aim of this study was to perform a comparative analysis of the immediate and long-term narrowing treatment results of the proximal part of the bulbar and membranous urethral parts using the developed magnifying and anastomotic methods. MATERIAL AND METHODS: A total of 102 patients with a confirmed diagnosis of stricture of the bulbomembranous urethral part of the urethra who underwent treatment in the urological hospital in Irkutsk City Clinical Hospital No. 1 during the period 2012-2018 participated in this prospective study. Urethroplasty operations were performed in two ways, using the anastomotic and intra-urethral substitution techniques. Through the assessment of preoperative parameters, statistical homogeneity of comparison groups was established. RESULTS: The final data analysis showed relapse for 4 patients from Group I and for 2 patients in Group II. The absence of relapse during the entire observation period was equal in both groups and after 2 years amounted to 83.0 ±7.9% in Group I and 92.5 ±5.1% in Group II. CONCLUSIONS: In both groups, the desired result was achieved - adequate independent urination was restored. The anastomotic method of urethroplasty should be used with caution in patients at risk groups, as well as with the presence of predictors of complications: previous transurethral surgeries on the urethra and prostate, anastomotic urethroplasty, radical prostatectomy. The developed minimally invasive substitution technique has a similar effectiveness with a lower risk of complications.

A multidisciplinary approach to urinary system iatrogenic injuries.

INTRODUCTION: Urinary system iatrogenic injuries appear because of urological, obstetric-gynecological, and surgical manipulations in the retroperitoneal space, pelvis, or perineum. The purpose of this research was to analyze and obtain knowledge about the issue of iatrogenic injuries, to apply injury prevention algorithms, and to assess multidisciplinary perspectives in modern surgery. MATERIAL AND METHODS: The research was interdisciplinary and consisted of several modules: a prospective, single-centre study of urinary system iatrogenic injuries (476 patients) along with four interregional and international procedural types of research. RESULTS: The analysis results indicate an extremely high significance of urinary system injuries evoking numerous negative consequences that are hard to eliminate. A comparative assessment of interdisciplinary interaction demonstrates the more effective interpretation of examination results, more comprehensive and credible clinical diagnosis, more qualitative evaluation of a patient's condition, more effective choice of initial treatment policy, and more satisfactory treatment in patients' opinion. The research allowed for the identification of a typical procedural mistake in the urethral catheter setting causing a high risk of urethra injuries followed by urethra strictures or consecutive infections of the urinary tract. CONCLUSIONS: More complicated treatment procedures cause a higher probability of urinary system iatrogenic injuries. The absence of unified algorithms and typical procedural mistakes cause such incidents. A partial solution to this issue could be found in a more profound interdisciplinary interaction in all treatment phases as well as in identifying and eliminating procedural mistakes.

Flavonoids with Glutathione Antioxidant Synergy: Influence of Free Radicals Inflow.

This report explores the antioxidant interaction of combinations of flavonoid-glutathione with different ratios. Two different 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid radical (ABTS•+)-based approaches were applied for the elucidation of the antioxidant capacity of the combinations. Despite using the same radical, the two approaches employ different free radical inflow systems: An instant, great excess of radicals in the end-point decolorization assay, and a steady inflow of radicals in the lag-time assay. As expected, the flavonoid-glutathione pairs showed contrasting results in these two approaches. All the examined combinations showed additive or light subadditive antioxidant capacity effects in the decolorization assay. This effect showed slight dilution dependence and did not change when the initial ABTS•+ concentration was two times as high or low. However, in the lag-time assay, different types of interaction were detected, from subadditivity to considerable synergy. Taxifolin-glutathione combinations demonstrated the greatest synergy, at up to 112%; quercetin and rutin, in combination with glutathione, revealed moderate synergy in the 30-70% range; while morin-glutathione appeared to be additive or subadditive. In general, this study demonstrated that, on the one hand, the effect of flavonoid-glutathione combinations depends both on the flavonoid structure and molar ratio; on the other hand, the manifestation of the synergy of the combination strongly depends on the mode of inflow of the free radicals.

Risk factors for recurrent lumbar disk herniation / Fatores de risco para hérnia de disco lombar recorrente / Factores de riesgo para la hernia discal lumbar recurrente

ABSTRACT Objective: to investigate the frequency of recurrent lumbar disk herniation (rLDH) and evaluated risk factors of rLDH in Russian population. Methods: this was a retrospective clinical study. From January 2015 to March 2022, 218 patients having single-level LDH at three institutes were included in this clinical study and who were then observed for a minimum of 5 years postoperatively. All the patients or relatives gave informed consent to participate in this study. The levels of disk herniation were L4-L5 in 132 cases (60.5 %), and L5-S1 in 86 cases (39.4 %). Results: The rLDH group was composed of 31 male and 12 female, whose ages ranged from 18 to 57 years (34.8±9.5 years). The non-rLDH group was composed of 97 male and 78 female, whose ages ranged from 19 to 73 years (47.5±9.8 years). According to the constructed binary logistic model, body mass index (p=0.021), current smoking (p=0.017), stage of disk degeneration (p=0.043), facet tropism (p=0.037), disk height index (p=0.018) and apparent diffusion coefficient (p=0.009) are significantly associated with incidence of rLDH. Conclusions: patients with these risk factors should be paid more attention for prevention of rLDH. Level of Evidence III; Retrospective Study.

RESUMO Objetivo: investigar a frequência de hérnia de disco lombar recorrente (rLDH) e avaliar os fatores de risco de rLDH na população russa. Métodos: este foi um estudo clínico retrospectivo. De janeiro de 2015 a março de 2022, 218 pacientes com LDH de nível único em três institutos foram incluídos neste estudo clínico e que foram observados por um período mínimo de 5 anos no pós-operatório. Todos os pacientes ou familiares deram consentimento informado para participar deste estudo. Os níveis de hérnia de disco foram L4-L5 em 132 casos (60,5%) e L5-S1 em 86 casos (39,4%). Resultados: o grupo rLDH foi composto por 31 homens e 12 mulheres, cujas idades variaram de 18 a 57 anos (34,8±9,5 anos). O grupo não-LDH foi composto por 97 homens e 78 mulheres, cujas idades variaram de 19 a 73 anos (47,5±9,8 anos). De acordo com o modelo logístico binário construído, índice de massa corporal (p=0,021), tabagismo atual (p=0,017), estágio de degeneração do disco (p=0,043), tropismo facetário (p=0,037), índice de altura do disco (p=0,018) e o coeficiente de difusão aparente (p=0,009) estão significativamente associados à incidência de rLDH. Conclusões: pacientes com esses fatores de risco devem receber mais atenção para prevenção de rLDH. Nível de evidência III; Estudo Retrospectivo.

RESUMEN Objetivo: investigar la frecuencia de hernia de disco lumbar recurrente (rLDH) y evaluar los factores de riesgo para rLDH en la población rusa. Métodos: se trata de un estudio clínico retrospectivo. Desde enero de 2015 hasta marzo de 2022, 218 pacientes con LDH de un solo nivel en tres institutos se inscribieron en este estudio clínico y se observaron durante un mínimo de 5 años después de la operación. Todos los pacientes o familiares dieron su consentimiento informado para participar en este estudio. Los niveles de hernia discal fueron L4-L5 en 132 casos (60,5%) y L5-S1 en 86 casos (39,4%). Resultados: el grupo rLDH estuvo compuesto por 31 hombres y 12 mujeres, cuyas edades oscilaron entre 18 y 57 años (34,8±9,5 años). El grupo no HDH estaba formado por 97 hombres y 78 mujeres, cuyas edades oscilaban entre 19 y 73 años (47,5±9,8 años). Según el modelo logístico binario construido, índice de masa corporal (p=0,021), tabaquismo actual (p=0,017), estadio de degeneración discal (p=0,043), tropismo facetario (p=0,037), índice de altura del disco (p =0,018) y el coeficiente de difusión aparente (p=0,009) se asocian significativamente con la incidencia de rLDH. Conclusiones: Los pacientes con estos factores de riesgo deberían recibir más atención para prevenir la rLDH. Nivel de evidencia II; Estudio Retrospectivo.

Prevalencia de la osificación heterotópica tras artroplastia de disco cervical a los 5 años / Prevalence of heterotopic ossification after cervical disk arthroplasty at 5 years

INTRODUCCION En los últimos años, la artroplastia de disco cervical (ADC) se ha utilizado ampliamente en pacientes como alternativa a la disectomía y fusión cervical anterior (DFCA). Sin embargo, se han informado osificación heterotópica (OH) y fusion espontánea después de ADCs, y el desarrollo de OH puede dificultar el mantenimiento de movimiento después de la artroplastia. MATERIALES Y METODOS El procedimiento ADC con prótesis Activ C y M6-C se realizó en 127 pacientes. El tiempo medio de seguimiento fue de 58.4 meses, con un rango de 51 a 66 meses. RESULTADOS Las osificaciones de grado 1 estuvieron presentes en 11 niveles (8,6%). Un total de 45 (35,4%) segmentos eran de OH de grado 2. Las OHs que produjeron restricciones del rango de movimiento estuvieron presentes en 13 (10,2%) casos. A los 5 años de seguimiento, sólo había 9 (7,0%) pacientes con osificación de grado 4 en el grupo de prótesis de disco artificial M6-C. En el análisis de la supervivencia tras la ocurrencia de OH, la mediana de los pacientes fue de 28,3 5,6 meses. El grupo de prótesis de disco artificial Activ C tuvo una supervivencia estadísticamente más larga (49,5 7,8 meses) que el grupo de disco M6-C. CONCLUSIONES En este estudio, el 61,4% de los pacientes desarrollaron OH en un período de seguimiento medio de 58,4 meses. En el análisis de la supervivencia tras la ocurrencia de OH, la mediana de los pacientes fue de 28.3 5.6 meses. El grupo de prótesis de disco artificial Activ C tuvo una supervivencia estadísticamente más larga (49.5 7.8 meses) que el grupo de disco M6-C.

INTRODUCTION In recent years, cervical disk arthroplasty (CDA) has become widely used in patients as a substitute to anterior cervical diskectomy and fusion (ACDF). However, heterotopic ossification (HO) and spontaneous fusion after CDA have been reported, and maintenance of motion following arthroplasty can be hindered by the development of HO. MATERIALS AND METHODS The CDA procedure with Activ C and M6-C prostheses was performed on 127 patients. The mean follow-up time was of 58.4 months, ranging from 51 to 66 months. RESULTS Grade-1 ossifications were present in 11 (8.6%) levels. A total of 45 (35.4%) segments showed grade-2 HO. Cases of HO that led to restrictions in the range of motion were present in 13 (10.2%) patients. Fives year postoperatively, there were only 9 (7.0%) patients with grade-4 ossifications in the M6-C artificial disk prosthesis group. In the survival analysis after HO occurrence, the median survival of the patients was of 28.3 5.6 months. The Activ C artificial disk prosthesis group had a statistically longer survival (49.5 7.8 months) than the M6-C disk group. CONCLUSION In the present study, 61.4% of the patients developed HO at a mean follow-up period of 58.4 months. In the survival analysis after HO occurrence, the median survival of the patients was of 28.3 5.6 months. The Activ C artificial disk prosthesis group had a statistically longer survival (49.5 7.8 months) than the M6-C disk group.

The prevalence of heterotopic ossification among patients after cervical disk arthroplasty at 5 years / Prevalência de ossificação heterotópica entre pacientes cinco anos depois de artroplastia de disco cervical / Prevalencia de osificación heterotópica en pacientes cinco años después de artroplastia de disco cervical

ABSTRACT Objective: This study was designed to evaluate the prevalence and grading of heterotopic ossification (HO) at five years, among patients after cervical disk arthroplasty (CDA). Methods: The CDA procedure with Activ C and M6-C prostheses was performed on 127 patients. The mean age of the cohort of patients was 38.4 years (range 18-49). The mean follow-up time was 58.4 months, ranging from 51 to 66 months. Results: Grade 1 ossifications were present in 11 (8.6 %) levels. A total of 45 (35.4 %) segments showed grade 2 HO. HO that led to restrictions in range of motion were present in 13 (10.2 %) cases. Five years after surgery, 9 (7.0 %) patients with grade 4 ossifications were found only in the M6-C artificial disk prosthesis group. In the analysis of patient survival following the occurrence of HO, all patients showed median survival of 28.3±5.6 months. The group that received the Activ C artificial disk prosthesis showed statistically longer survival (49.5±7.8 months) than the M6-C disk group. Conclusions: In our study 61.4% of patients exhibited HO after a mean follow-up of 58.4 months. In the analysis of patient survival after HO, all patients showed median survival of 28.3±5.6 months. The group that received the Activ C artificial disk prosthesis showed statistically longer survival (49.5±7.8 months) than the M6-C disk group. Level of evidence III; Cross-sectional Observational Study.

RESUMO Objetivo: Este estudo foi desenhado para avaliar a prevalência e o grau de ossificação heterotópica (HO) entre pacientes depois de cinco anos de artroplastia de disco cervical (CDA). Métodos: O procedimento de CDA com próteses Activ C e M6-C foi realizado em 127 pacientes. A média de idade da coorte de pacientes foi de 38,4 anos (variação de 18 a 49). O tempo médio de acompanhamento foi de 58,4 meses, variando de 51 a 66 meses. Resultados: Ossificações de grau 1 foram encontradas em 11 (8,6%) níveis. Um total de 45 (35,4%) segmentos apresentou HO de grau 2. As HO que levaram à restrição da amplitude de movimento foram verificadas em 13 (10,2%) casos. Cinco anos depois da cirurgia, 9 (7,0%) pacientes com ossificações de grau 4 foram vistas apenas no grupo de prótese do disco artificial M6-C. Na análise de sobrevida depois da ocorrência de HO, todos os pacientes tinham sobrevida mediana de 28,3 ± 5,6 meses. O grupo que recebeu a prótese de disco artificial Activ C tinha sobrevida estatisticamente maior (49,5 ± 7,8 meses) do que a do grupo com disco M6-C. Conclusões: Em nosso estudo, 61,4% dos pacientes apresentaram HO no acompanhamento médio de 58,4 meses. Na análise de sobrevida depois de ocorrência de HO, todos os pacientes tinham sobrevida mediana de 28,3 ± 5,6 meses. O grupo que recebeu a prótese de disco artificial Activ C teve sobrevida estatisticamente maior (49,5 ± 7,8 meses) do que o grupo de disco M6-C. Nível de evidência III; Estudo Observacional Transversal.

RESUMEN Objetivo: Este estudio fue diseñado para evaluar la prevalencia y el grado de osificación heterotópica (HO) entre pacientes después de cinco años de artroplastia de disco cervical (CDA). Métodos: Se realizó el procedimiento de CDA con prótesis Activ C y M6-C en 127 pacientes. La edad promedio de la cohorte de pacientes fue de 38,4 años (rango 18-49). El tiempo medio de seguimiento fue de 58,4 meses, con un rango de 51 a 66 meses. Resultados: Se encontraron osificaciones de grado 1 en 11 (8,6%) niveles. Un total de 45 (35,4%) segmentos presentaron HO de grado 2. Las HO que llevaron a restricciones en el rango de movimiento estuvieron presentes en 13 (10,2%) casos. Cinco años después de la cirugía, se observaron 9 (7,0%) pacientes con osificaciones de grado 4 sólo en el grupo de prótesis de disco artificial M6-C. En el análisis de sobrevida tras la ocurrencia de HO, todos los pacientes presentaron una media de sobrevida de 28,3±5,6 meses. El grupo que recibió la prótesis de disco artificial Activ C presentó una sobrevida estadísticamente más larga (49,5±7,8 meses) que el grupo del disco M6-C. Conclusiones: En nuestro estudio el 61,4% de los pacientes presentaron HO en el seguimiento medio de 58,4 meses. En el análisis de sobrevida tras la ocurrencia de HO, todos los pacientes presentaron mediana de sobrevida de 28,3±5,6 meses. El grupo de prótesis de disco artificial Activ C tuvo una sobrevida estadísticamente más larga (49,5±7,8 meses) que el grupo de disco M6-C. Nivel de evidencia III; Estudio observacional transversal.

A scoring system to predict the risk of surgical site infections after spinal surgery / Sistema de pontuação para prever o risco de infecções locais depois de cirurgia da coluna / Sistema de puntuación para predecir el riesgo de infecciones locales después de cirugía de la columna

ABSTRACT Objective This retrospective clinical study was carried out to generate and cross-validate a scoring system for the identification of patients at risk of SSIs after spinal surgery. Methods A retrospective study was conducted, which included patients who underwent spinal surgery. The potential variables for SSIs were extracted from the database, including preoperative, intraoperative and postoperative risk factors for univariate and multivariate regression analyses. Results A total of 2347 patients were included in this retrospective clinical study. Postoperative SSIs were observed in 53 patients (2.2%). The multivariate logistic regression analysis revealed the following risk factors for SSIs after spinal surgery: diabetes mellitus ( P =0.029), body mass index ( P =0.008), low serum calcium concentration ( P =0.012), low pre- and postoperative albumin ( P =0.023, P =0.037), more than three operated segments ( P =0.008), operation time of more than 180 minutes ( P =0.019), estimated blood loss ( P =0.011), low postoperative hemoglobin ( P =0.017) and prolonged drainage time ( P =0.025). Each of these factors contributed 1 point to the risk score. The predicted rates of incidence for the low-, intermediate-, high-, and extremely high-risk categories in the validation set were 1.4%, 12%, 41.6%, and 66.6%, respectively. Conclusions Our scoring system allows for easy and validated risk stratification of SSIs after spinal surgery. Level of evidence III; Cross-sectional Observational Study.

RESUMO Objetivo Este estudo clínico cruzado retrospectivo foi realizado para gerar e validar um sistema de pontuação para a identificação de pacientes com risco de ICL após cirurgia da coluna vertebral. Métodos Foi realizado um estudo retrospectivo que incluiu pacientes submetidos à cirurgia de coluna vertebral. As possíveis variáveis para ICL foram extraídas do banco de dados, incluindo fatores de risco pré-operatórios, intraoperatórios e pós-operatórios para análises de regressão univariada e multivariada. Resultados Um total de 2.347 pacientes foram incluídos neste estudo clínico retrospectivo. As ICLs pós-operatórias foram observadas em 53 pacientes (2,2%).A análise de regressão logística multivariada revelou os seguintes fatores de risco de ICL depois de cirurgia da coluna: diabetes mellitus (P = 0,029), índice de massa corporal (P = 0,008), baixa concentração sérica de cálcio (P = 0,012), albumina pré e pós-operatória baixa (P = 0,023, P=0,037), mais de três segmentos operados (P = 0,008), tempo de cirurgia superior a 180 minutos (P = 0,019), perda de sangue estimada (P = 0,011), hemoglobina pós-operatória baixa (P = 0,017) e tempo prolongado de drenagem (P = 0,025). Cada um desses fatores contribuiu com 1 ponto para o escore de risco. As taxas de incidência previstas para as categorias de risco baixo, intermediário, alto e extremamente alto no conjunto de validação foram 1,4%, 12%, 41,6% e 66,6%, respectivamente. Conclusões Nosso sistema de pontuação permite uma estratificação de risco fácil e validada das ICLs depois de cirurgia da coluna. Nível de evidência III; Estudo Observacional Transversal.

RESUMEN Objetivo Este estudio clínico cruzado retrospectivo se realizó para generar y validar un sistema de puntuación para la identificar pacientes en riesgo de IQL después de cirugía de columna. Métodos Se realizó un estudio retrospectivo que incluyó pacientes sometidos a cirugía de columna. Las posibles variables de IQL se recopilaron de la base de datos, incluidos los factores de riesgo preoperatorios, intraoperatorios y posoperatorios para análisis de regresión univariados y multivariados. Resultados Se incluyó un total de 2.347 pacientes. Las IQLs posoperatorias se observaron en 53 pacientes (2,2%). El análisis de regresión logística multivariante reveló los siguientes factores de riesgo de IQL después de cirugía de columna: diabetes mellitus (P = 0,029), índice de masa corporal (P = 0,008), baja concentración sérica de calcio (P = 0,012), albúmina baja en el período pre y posoperatorio (P = 0,023, P = 0,037), más de tres segmentos operados (P = 0,008), tiempo de cirugía mayor de 180 minutos (P = 0,019), pérdida de sangre estimada (P = 0,011), hemoglobina postoperatoria baja (P = 0,017) y tiempo de drenaje prolongado (P = 0,025). Cada uno de estos factores contribuyó con 1 punto a la puntuación de riesgo. Las tasas de incidencia previstas para las categorías de riesgo bajo, intermedio, alto y extremadamente alto en el conjunto de validación fueron 1,4%, 12%, 41,6% y 66,6%, respectivamente. Conclusiones Nuestro sistema de puntuación permite una estratificación de riesgo fácil y validada de las IQLs después de la cirugía de columna. Nivel de evidencia III; Estudio observacional transversal.