P4766Edoxaban Treatment in routiNe clinical prActice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe): 1-year follow-up according to body mass index

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Weiss ◽  
R De Caterina ◽  
P Kelly ◽  
P Monteiro ◽  
J C Deharo ◽  
...  

Abstract Background Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), and available routine care data have so far broadly confirmed the safety of different NOACs in routine practice. However, such data for edoxaban are scarce, especially in extremely low and high body weight (BW). These extreme BWs may affect the bioavailability, distribution, and half-life of NOACs and, consequently, outcomes of treatment. Methods We analysed outcomes in normal-weight (BMI 18.5–25) vs overweight (BMI 25–30) and obese (BMI >30) patients enrolled into the ETNA-AF-Europe observational study (NCT02944019) collecting information on patients treated with edoxaban in 825 sites in 10 European countries. This snapshot analysis set includes data of 7,672 patients (56.3% of all enrolled patients) which have completed their 1-year follow-up visit (mean follow-up: 343.5 days). Results Median patient age was 74 years for all patients, 76 years for patients with a BMI 18.5–25 (group 1), 75 years for patients with BMI 25–30 (group 2), and 72 for patients with a BMI >30 (group 3). CrCl was 64 mL/min for patients with a BMI 18.5–25, 68 mL/min for patients with BMI 25–30, and 72 mL/min for patients with a BMI >30. The CHA2DS2-VASc (mean 3.1±1.38) and HAS-BLED (mean 2.5±1.10) score did not differ significantly between groups. As expected, diabetes and hypertension were significantly less prevalent in leaner patients and - accordingly - inversely correlated to age. There was no correlation between body weight and life-threatening bleeding (group 1: 0.28%; group 2: 0.40%; group 3: 0.14%). Also, stroke rates (group 1: 0.74%; group 2: 0.81%; group 3: 0.76%) did not differ between groups. Conclusion BMI, within the range here assessed, does not affect 1-year outcomes in European AF patients treated with edoxaban. Acknowledgement/Funding Daiichi Sankyo Europe GmbH, Munich, Germany

2021 ◽  
Vol 11 (5) ◽  
pp. 389-400
Author(s):  
E. A. Praskurnichiy ◽  
O. I. Morozova

Aims. To evaluate the impact of body weight dynamics on the clinical course of atrial fibrillation in obese patients.Materials and methods. The study included 101 primary obese patients with paroxysmal or persistent atrial fibrillation. Study design: a retrospective, single-center, comparative study. Retrospectively аccording to the he body weight dynamics, patients were divided into 3 groups: those who increased their body weight by >3 % (Group 1, n=40), maintained their initial body weight by ±2.9 % (Group 2, n=29), and reduced their initial body weight by >3 % (Group 3, n=32). Follow-up examinations by a doctor were carried out at least once every 6 months for minimum 36 months. Change in AF type was determined by disease patterns and 7-day Holter monitoring results. The groups were comparable in gender (p=0,9267), age (p=0,3841), height (p=0,8900), and disease form (Paroxysmal atrial fibrillation /Persistent atrial fibrillation) (p=0,8826), the severity of symptoms on the European Heart Rhythm Association score of atrial fibrillations (p=0,8687) and systolic blood pressure at the beginning of the study (p=0,4500).Results. At the final control examination, the body weight of patients in Group 1 increased by an average of 11,4 [9,3; 13,1] kg (р <0,001*), while weight loss in Group 3 averaged -6,2 [-8,4; -5,3] kg (p <0,001*). The decrease in body weight of Group 2 patients was insignificant (p=0,5377) and amounted to -0,1 [-2,0; 1,3] kg. The progression of the disease from paroxysmal to persistent form was observed among 15 (37 %) patients in Group 1, 9 (31 %) patients — in Group 2, 2 (6 %) patients — in Group 3 (p=0,0079*). The regression of arrhythmia from persistent to paroxysmal form was not registered in group 1 (0 %), in group 2, the reverse development of the disease was noted in 1 patient (3 %) and in group 3 — in 6 patients (19 %) (p=0,0053*). There were no free from AF patients in Group 1 at the final follow-up, while 2 (7 %) patients were free from AF in Group 2 and 7 (22 %) — in Group 3 (р=0,0047*). In patients undergoing ablation, procedural success was determined after a 3-month blind period. The need for interventional procedures to restore the sinus rhythm and their multiplicity when comparing the groups did not differ significantly. However, in a pairwise comparison, the difference between groups 1 and 3 of participants was statistically significant (p=0,0079* and p=0,0374*, respectively). Conclusion. This study demonstrates the relationships between the dynamics of body weight and the clinical course of atrial fibrillation. The progression of obesity leads to the progression of the disease. Weight-loss management reverses the type and natural progression of AF, improves the prognosis and the course of disease, regardless of other significant risk factors, increases the anti-arrhythmic therapy effect and the effect of interventional treatment.


2015 ◽  
Vol 23 (4) ◽  
pp. 384-391 ◽  
Author(s):  
Ozcan Basaran ◽  
Nesrin Filiz Basaran ◽  
Edip Guvenc Cekic ◽  
Ibrahim Altun ◽  
Volkan Dogan ◽  
...  

Introduction: Inappropriate use of oral anticoagulants (OACs) have not been well investigatedand, however, may be frequent in real-world practice in patients with nonvalvular atrial fibrillation (NVAF). This study was designed to evaluate the prescription patterns and appropriateness of OACs in patients with NVAF in real-world clinical settings. Methods: We performed a prospective, observational study (NCT02366338). A total of 148 patients with NVAF were screened for OAC prescription. Appropriateness of prescribing was evaluated using 9 criteria of the Medication Appropriateness Index (MAI): indication, choice, dosage, modalities and practicability of administration, drug–drug interactions, drug–disease interactions, duplication, and duration. For each criterion, the evaluator has to rate whether the medication is (A) appropriate, (B) inappropriate but with limited clinical importance, and (C) inappropriate. Results: Of 148 patients, 73 (50%) were on warfarin (group 1), 39 (26%) were on rivaroxaban (group 2), and 36 (24%) were on dabigatran therapy (group 3). The MAI showed that 83% of group 1, 28% of group 2, and 47% of group 3 patients had at least 1 inappropriate criterion. Moreover, according to the choice criterion, 37% of group 1, 8% of group 2 and 5% of group 3 were rated as inappropriate, and dosage was not appropriate in 77% of group 1, 23% of group 2, and 42% of group 3. Conclusion: Inappropriate drug use is frequent among patients with NVAF not only for warfarin but also for NOACs. Although there is an apparent improvement in thromboprophylaxis of NVAF, much more effort is needed for appropriate use of OACs.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
T Chao ◽  
Y.H Chan ◽  
G.Y.H Lip ◽  
S.A Chen

Abstract Background Hemoglobin (Hgb) levels and platelet (PLT) counts have beeen associated with adverse clinical outcomes in some patients with cardiovascular conditions. We aimed to assess the risks of clinical events among patients with atrial fibrillation (AF) in relation to Hgb levels and PLT counts. Second, we investigated clinical outcomes on warfarin or non-vitamin K antagonist oral anticoagulants (NOACs) compared to no oral anticoagulant use (non-OAC), in different Hgb and PLT strata. Methods We used medical data from a multi-center healthcare system in Taiwan which included 37,074 AF patients. Patients were categorized into 3 groups based on their Hgb levels and PLT counts: Group 1 (Hgb&gt;10g/dL and PLT&gt;100K/uL; n=29,147), Group 2 (Hgb&lt;10g/dL or PLT&lt;100K/uL; n=7,078) and Group 3 (Hgb&lt;10g/dL and PLT&lt;100K/uL; n=849). Patients in each category were further stratified as 3 groups according to their stroke prevention strategies; that is, non-OAC, warfarin or NOACs. Results A higher Hgb level and/or PLT count was associated with a higher risk of ischemic stroke/systemic embolism (IS/SE), but lower risks of intracranial hemorrhage (ICH) and major bleeding. The composite risks of IS/SE, ICH and major bleeding were higher in Group 3 or Group 2, compared to Group 1 (6.75%/yr versus 6.41%/yr versus 4.13%/yr). Compared to non-OACs, the use of warfarin was not associated with a lower composite risk of IS/SE, ICH and major bleeding in the 3 groups. NOACs were associated with a lower composite risk in Group 1 (aHR 0.68, 95% CI 0.60–0.76) and Group 2 (aHR 0.73, 95% CI 0.53–0.99), but was non-significant in Group 3 (aHR 0.73, 95% CI 0.17–3.07) (Figure). The net clinical benefits were consistently positive in different weight models, in favor of NOAC use, in Group 2 and its subgroups with either anemia or thrombocytopenia. Conclusions AF patients with anemia and/or thrombocytopenia were a high-risk population. Compared to no OAC use, NOACs were associated with significantly better clinical outcomes for patients with advanced anemia (Hgb&lt;10g/dL) or thrombocytopenia (PLT&lt;100K/uL), but not for those with both conditions. Harms or benefits of NOACs should be carefully evaluated and balanced in this population. FUNDunding Acknowledgement Type of funding sources: None.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Toma ◽  
E Rrapaj ◽  
S Giovinazzo ◽  
M Sarocchi ◽  
G Stronati ◽  
...  

Abstract Background Direct oral anticoagulants (DOAC) are the standard of care for the prophylaxis of non-valvular atrial fibrillation (NVAF)-cardioembolism, but their use in oncological patients has been limited so far. Methods We retrospectively reviewed the records of the patients referred to two cardio-oncology outpatient units between January 2017 and July 2019, and selected those presenting with NVAF, CHA2DS2-VASc ≥1 for men and ≥2 for women, and cancer on active treatment. The following were considered as contraindications to DOAC: severe chronic kidney disease; anti-neoplastic therapy unknown or with potential moderate-to-severe adverse interactions; cirrhosis or liver metastases. Clinical characteristics of patients on DOAC (group 1), on VKA or LMWH with at least 1 contraindication to DOAC (group 2), and on VKA or LMWH despite not having contraindications to DOAC (group 3) were compared by chi-square or ANOVA. Results Of a total of 3,831 patients, 264 (6.9%) met the inclusion criteria (Figure 1). One-hundred fourteen (43.2%) were in group 1, 61 (23.1%) in group 2 (18 on VKA, 43 on LMWH), and 65 (24.6%) in group 3 (27 on VKA, 38 on LMWH). Anticoagulation was omitted in 24 (9.1%) cases for various reasons: spontaneous bleeding (5), anaemia and/or thrombocytopenia (5), frailty (4), CHA2DS2-VASc 1 (3), pharmacological interactions (1), single episode of NVAF (1); and not clearly motivated in 5 subjects. The only significant difference between the 3 groups was serum creatinine concentration (Table 1). Of note, only 10% of subjects in group 1 received an inappropriate DOAC dose, while LMWH was under-dosed for 18% of patients in group 2 and 31% of patients in group 3 (P=0.002). Conclusions In the setting of a dedicated cardio-oncology consultation, DOAC and VKA are most often appropriately prescribed to cancer patients with NVAF. However, there is residual use of LMWH, not infrequently at non-anticoagulant dosage. This is a non-evidence based common practice in clinical oncology that clearly must be abandoned Figure 1 Funding Acknowledgement Type of funding source: None


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4045-4045
Author(s):  
Patricia Casais

Abstract Introduction: Our objectives were to investigate if aging is an independent risk factor for major bleeding during oral anticoagulant treatment (OAT) for atrial fibrillation (AF). Patients and Methods: An inception cohort study was designed to include patients (pts) referred to our Department to initiate OAT due to AF from July 2000 to July 2007. Inclusion criteria: no prior OAT, AF being the only reason to OAT, follow-up at our Institution, and signed informed consent. Exclusion criteria: concomitant reason for OAT, and pts refusal to participate. Pts were followed until OAT was stopped by the patient’s cardiologist or until July 2007. Patients who underwent a successful electric cardioversion and were followed up only for 4 weeks were not included unless they presented a bleeding episode. Epidemiological and clinical data were documented for all patients. Major bleeding episodes, age, time on OAT, and INR at the bleeding event were recorded. Deaths were registered and classified as “related” or “not related” to OAT. For the analysis, the inception cohort was divided into three groups according to the age of beginning and ending of OAT. Group 1 included patients younger than 77 at the end of OAT. Group 2 was constituted by the patients that initiated therapy before 80 and were followed after that age. Patients starting after 80 years of age were the group 3. Time in therapeutic range and INR variability were calculated. Incidence rate and relative risk (RR) of major hemorrhage (MH) was estimated. Results: During the study period, 2.971 patients were referred for initiation of OAT, 40% (1.172) had AF, and 671 met the exclusion criteria (138 patients had a prior OAT, 111 were not going to go on control OAT at the Institution, and 422 had a concomitant reason for OAT (mitral estenosis, heart valve prostheses, venous thrombosis, coronary artery by-pass, etc.) Five-hundred and one patients were included in the study, 68 (13.5%) were lost for follow-up after inclusion or had less than 4 weeks after initiation, and 433 had complete follow-up. Patients’ characteristics and MH are shown in Table 1. Time within therapeutic range was similar in all age-groups (65.0%, 62.8%, and 65.4% for group 1, 2 and 3, respectively). There were 28 MH in 23 pts during the study period. In group 3, the rate of MH was 3.39/100 patient-years while in group 1 it was 0.85/100 patient-years. The RR was 3.0 (1.2–7.6 95%CI) in group 3 compared to group 1(p= 0.02). Among patients in group 2, the RR of bleeding increased to 5.8 (2.27–14.95) after the age of 80. The likelihood ratio of MH with increasing age was 14.1 (p= 0.001). INR variability tended to be higher in Group 3 and in bleeding patients regardless their age. Aspirin, number of concomitant medications and CHADS2 score were not associated with the risk of MH. There were 10 deaths, all in pts older than 80. In 9/10 the cause of death was documented and was unrelated to OAT. One patient died after a non-characterized stroke, it was considered hemorrhagic. Rate of death related to bleeding after age of 80 (groups 2 and 3) was 0.54%. Conclusions: This long-term follow up cohort study shows that aging is an independent risk factor for MH; this observation might have clinical implications for the management of elderly pts. Table 1: Patients’ characteristics Group 1 Group 2 Group 3 N 249 55 129 * 8/9 events after the age of 80. Sex Female (%)&#x2028; Male (%) 55 (49.5)&#x2028; 56 (50.0) 29 (54)&#x2028; 25 (46) 69 (55)&#x2028; 57 (45) Age at beginning OAT mean± SD 63.9±8.4 74.9 ± 2.0 82.8 ± 2.7 Age at ending OAT mean± SD 68.7±7.9 81.3 ± 1.4 85.7 ± 3.1 Follow-up (years) mean± SD 5.2±0.2 4.5 ±0.3 2.5 ± 0.1 Prior ischemic stroke N (%) 15 (13.5) 9 (17) 28 (22) Deaths N (%) 0 1 (2) 9 (7%) Major hemorrhages Events (pts) 8 (7) 9 (8)* 11 (8) Mean age (years) 68.4 ± 2.6 79.7 ± 0.5 83.0 ± 0.8 Mean Time on OAT (weeks± SE) 32.1±8 142.2 ± 28.6 77.8 ± 22.5 Mean INR ±SE at 3.9 ± 0.7 3.5 ± 1.0 3.6 ± 0.5 1st event (range) (2.6–8.2) (2.0–10.8) (1.6–6.0)


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Ikeda ◽  
M Iguchi ◽  
H Ogawa ◽  
K Ishigami ◽  
Y Aono ◽  
...  

Abstract Background Previous studies have suggested that proteinuria is independently associated with clinical outcomes in diabetic patients, irrespective of the presence of renal dysfunction. However, data regarding the impact of proteinuria on clinical outcomes in diabetic patients with atrial fibrillation (AF) are limited. Methods The Fushimi AF Registry is a community-based prospective survey of AF patients in our city in Japan. Follow-up data were available in 4,454 patients, and 634 diabetic patients with available data of proteinuria and estimated glomerular filtration rate (eGFR) were examined. We compared the clinical background and outcomes between patients with proteinuria (n=251) and those without (n=383). Then, we divided the patients into 4 subgroups according to the presence of proteinuria and renal dysfunction, and compared the clinical outcomes between groups; group 1 (without proteinuria, eGFR ≥60 ml/min/1.73 m2; n=203), group 2 (with proteinuria, eGFR ≥60; n=96), group 3 (without proteinuria, eGFR <60; n=180), group 4 (with proteinuria, eGFR <60; n=155). Results Age was comparable between patients with or without proteinuria. Patients with proteinuria had higher prevalences of previous heart failure (HF), stroke/systemic embolism, hypertension and renal dysfunction. The prevalences of previous myocardial infarction, and major bleeding were similar between two groups. During the median follow-up of 1,505 days, the incidence rates of HF hospitalization (4.1/100 person-years vs. 2.5/100 person-years; p<0.01) and cardiovascular death (1.8/100 person-years vs. 0.4/100 person-years; p<0.01) were higher in patients with proteinuria. When we divided patients into 4 subgroups, the incidences of HF hospitalization (group 1: 1.8/100 person-years vs. group 2: 3.4/100 person-years vs. group 3: 3.8/100 person-years vs. group 4: 4.9/100 person-years; p<0.01) and cardiovascular death (group 1: 0.3/100 person-years vs. group 2: 1.8/100 person-years vs. group 3: 0.5/100 person-years vs. group 4: 2.2/100 person-years; p<0.01) tended to be higher in not only group 3 and group 4 but also group 2 than group 1 (Figure). Multivariate Cox proportional hazards regression analysis including female gender, age (≥75 years), hypertension, pre-existing HF, renal dysfunction (eGFR <60),low left ventricular ejection fraction (<40%) and proteinuria revealed that proteinuria was an independent determinant of both of HF hospitalization (adjusted hazard ratio [HR]: 1.57, 95% confidence interval [CI]: 1.05–2.34) and cardiovascular death (HR: 3.76, 95% CI: 1.59–8.88). Figure 1 Conclusion In Japanese diabetic patients with AF, proteinuria was associated with higher incidences of HF hospitalization and cardiovascular death, irrespective of the presence of renal dysfunction.


Arthroplasty ◽  
2021 ◽  
Vol 3 (1) ◽  
Author(s):  
Zhijie Chen ◽  
Kaizhe Chen ◽  
Yufei Yan ◽  
Jianmin Feng ◽  
Yi Wang ◽  
...  

Abstract Objective To evaluate the effect of medial posterior tibial slope (PTS) on mid-term postoperative range of motion (ROM) and functional improvement of the knee after medial unicompartmental knee arthroplasty (UKA). Methods Medical records of 113 patients who had undergone 124 medial UKAs between April 2009 through April 2014 were reviewed retrospectively. The mean follow-up lasted 7.6 years (range, 6.2–11.2 years). Collected were demographic data, including gender, age, height, weight of the patients. Anteroposterior (AP) and lateral knee radiographs of the operated knees were available in all patients. The knee function was evaluated during office follow-up or hospital stay. Meanwhile, postoperative PTS, ROM, maximal knee flexion and Hospital for Special Surgery (HSS) knee score (pre−/postoperative) of the operated side were measured and assessed. According to the size of the PTS, patients were divided into 3 groups: group 1 (<4°), group 2 (4° ~ 7°) and group 3 (>7°). The association between PTS and the knee function was investigated. Results In our cohort, the average PTS was 2.7° ± 0.6° in group 1, 5.6° ± 0.9° in group 2 and 8.7° ± 1.2° in group 3. Pairwise comparisons showed significant differences among them (p < 0.01). The average maximal flexion range of postoperative knees in each group was 112.4° ± 5.6°, 116.4° ± 7.2°, and 117.5° ± 6.1°, respectively, with significant difference found between group 1 and group 2 (p < 0.05), and between group 1 and group 3 (p < 0.05). However, the gender, age, and body mass index (BMI) did not differ between three groups and there was no significant difference between groups in terms of pre−/postoperative HSS scores or postoperative knee ROM. Conclusion A mid-term follow-up showed that an appropriate PTS (4° ~ 7°) can help improve the postoperative flexion of knee. On the other hand, too small a PTS could lead to limited postoperative knee flexion. Therefore, the PTS less than 4° should be avoided during medial UKA.


2021 ◽  
pp. 1-7
Author(s):  
Emre Erdem ◽  
Ahmet Karatas ◽  
Tevfik Ecder

<b><i>Introduction:</i></b> The effect of high serum ferritin levels on long-term mortality in hemodialysis patients is unknown. The relationship between serum ferritin levels and 5-year all-cause mortality in hemodialysis patients was investigated in this study. <b><i>Methods:</i></b> A total of 173 prevalent hemodialysis patients were included in this study. The patients were followed for up to 5 years and divided into 3 groups according to time-averaged serum ferritin levels (group 1: serum ferritin &#x3c;800 ng/mL, group 2: serum ferritin 800–1,500 ng/mL, and group 3: serum ferritin &#x3e;1,500 ng/mL). Along with the serum ferritin levels, other clinical and laboratory variables that may affect mortality were also included in the Cox proportional-hazards regression analysis. <b><i>Results:</i></b> Eighty-one (47%) patients died during the 5-year follow-up period. The median follow-up time was 38 (17.5–60) months. The 5-year survival rates of groups 1, 2, and 3 were 44, 64, and 27%, respectively. In group 3, the survival was lower than in groups 1 and 2 (log-rank test, <i>p</i> = 0.002). In group 1, the mortality was significantly lower than in group 3 (HR [95% CI]: 0.16 [0.05–0.49]; <i>p</i> = 0.001). In group 2, the mortality was also lower than in group 3 (HR [95% CI]: 0.32 [0.12–0.88]; <i>p</i> = 0.026). No significant difference in mortality between groups 1 and 2 was found (HR [95% CI]: 0.49 [0.23–1.04]; <i>p</i> = 0.063). <b><i>Conclusion:</i></b> Time-averaged serum ferritin levels &#x3e;1,500 ng/mL in hemodialysis patients are associated with an increased 5-year all-cause mortality risk.


Cartilage ◽  
2021 ◽  
pp. 194760352110309
Author(s):  
Alexandre Barbieri Mestriner ◽  
Jakob Ackermann ◽  
Gergo Merkely ◽  
Pedro Henrique Schmidt Alves Ferreira Galvão ◽  
Luiz Felipe Morlin Ambra ◽  
...  

Objective To determine the relationship between cartilage lesion etiology and clinical outcomes after second-generation autologous chondrocyte implantation (ACI) in the patellofemoral joint (PFJ) with a minimum of 2 years’ follow-up. Methods A retrospective review of all patients that underwent ACI in the PFJ by a single surgeon was performed. Seventy-two patients with a mean follow-up of 4.2 ± 2.0 years were enrolled in this study and were stratified into 3 groups based on the etiology of PFJ cartilage lesions: patellar dislocation (group 1; n = 23); nontraumatic lesions, including chondromalacia, osteochondritis dissecans, and degenerative defects (group 2; n = 28); and other posttraumatic lesions besides patellar dislocations (group 3; n = 21). Patient’s mean age was 29.6 ± 8.7 years. Patients in group 1 were significantly younger (25.4 ± 7.9 years) than group 2 (31.7 ± 9.6 years; P = 0.025) and group 3 (31.5 ± 6.6 years; P = 0.05). Body mass index averaged 26.2 ± 4.3 kg/m2, with a significant difference between group 1 (24.4 ± 3.2 kg/m2) and group 3 (28.7 ± 4.5 kg/m2; P = 0.005). A clinical comparison was established between groups based on patient-reported outcome measures (PROMs) and failure rates. Results Neither pre- nor postoperative PROMs differed between groups ( P > 0.05). No difference was seen in survivorship between groups (95.7% vs. 82.2% vs. 90.5%, P > 0.05). Conclusion Cartilage lesion etiology did not influence clinical outcome in this retrospective study after second generation ACI in the PFJ. Level of Evidence Level III, retrospective comparative study.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Arkadiusz Jundziłł ◽  
Piotr Kwieciński ◽  
Daria Balcerczyk ◽  
Tomasz Kloskowski ◽  
Dariusz Grzanka ◽  
...  

AbstractThe use of an ileal segment is a standard method for urinary diversion after radical cystectomy. Unfortunately, utilization of this method can lead to numerous surgical and metabolic complications. This study aimed to assess the tissue-engineered artificial conduit for urinary diversion in a porcine model. Tissue-engineered tubular polypropylene mesh scaffolds were used for the right ureter incontinent urostomy model. Eighteen male pigs were divided into three equal groups: Group 1 (control ureterocutaneostomy), Group 2 (the right ureter-artificial conduit-skin anastomoses), and Group 3 (4 weeks before urostomy reconstruction, the artificial conduit was implanted between abdomen muscles). Follow-up was 6 months. Computed tomography, ultrasound examination, and pyelogram were used to confirm the patency of created diversions. Morphological and histological analyses were used to evaluate the tissue-engineered urinary diversion. All animals survived the experimental procedures and follow-up. The longest average patency was observed in the 3rd Group (15.8 weeks) compared to the 2nd Group (10 weeks) and the 1st Group (5.8 weeks). The implant’s remnants created a retroperitoneal post-inflammation tunnel confirmed by computed tomography and histological evaluation, which constitutes urostomy. The simultaneous urinary diversion using a tissue-engineered scaffold connected directly with the skin is inappropriate for clinical application.


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