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1.
J Vasc Access ; : 11297298241262344, 2024 Aug 01.
Article in English | MEDLINE | ID: mdl-39091077

ABSTRACT

Central venous catheters are a frequently used vascular access for hemodialysis. Fibrin sheath formation is a common complication and is associated with catheter malfunction. Although fibrin sheath angioplasty with catheter exchange is a frequently employed procedure, it can be associated with mechanical complications. An important technical step in this procedure is progression of the guide-wire into the inferior vena cava. Focal alveolar hemorrhage is a very rare complication of this procedure. We report a case of a 70-year old patient on dual antiplatelet therapy who underwent fibrin sheath angioplasty with guide-wire catheter exchange and experienced focal alveolar hemorrhage presenting as hemoptysis and acute type 1 respiratory failure. Progression of the guide-wire into the pulmonary circulation and antithrombotic therapy played a significant role in the development of this complication. This report aims to call attention to a poorly described and potentially serious yet avoidable complication of fibrin sheath angioplasty with guide-wire catheter exchange.

2.
J Vasc Access ; : 11297298241260899, 2024 Aug 03.
Article in English | MEDLINE | ID: mdl-39097790

ABSTRACT

PURPOSE: To quantify the rates and identify risk factors for the complications of central venous access devices (CVADs) removal in children. METHOD: Retrospective (2018-2023) review of children undergoing CVADs removal at a single institution. Data are reported as frequency, percentages and median. Logistic regression analysis was used to identify risk factors associated with difficult removal. Receiver Operating Characteristic Curve (ROC) analysis was conducted to identify the age cut-off and positive likelihood ratio (+LH) for the indwelling time associated with complicated removal. p-Value <0.05 were considered statistically significant. RESULTS: We identified 208 CVAD removals with a median age of 7.2 (0.2-18.4) years including 116 (55.8%) males. The median CVAD placement duration was 1.26 years (0.4-5.7) years. Indications for insertion included acute lymphoblastic leukaemia (ALL; 78/208, 37.5%), lymphomas (31/208, 14.9%), other malignancies (58/208, 27.9%). Removal indications included completion of treatment (144/208, 69.2%), infection (22/208, 10.6%), malfunction (7/208, 3.4%) and other reasons (35/208, 16.8%). There were 20 (9.6%) complications characterised by difficulty removing the CVAD. Complicated removals were more likely to occur in children with ALL as the primary diagnosis (p = 0.001); independently of the indication for insertion, longer indwelling time was associated with higher risk of complicated removal (p < 0.001). Indwelling time >2.09 years was associated with a 2.87 increased risk of difficult removal. CONCLUSION: In our experience, almost 10% of CVAD removals in children result in complications. These findings are associated with an indwelling time >2 years; strategies to prevent complicated removals should be considered in children requiring long-term central venous access.

3.
J Vasc Access ; : 11297298241265163, 2024 Aug 03.
Article in English | MEDLINE | ID: mdl-39097789

ABSTRACT

The Renal Expert in Vascular Access (REVAC) is one of the four modules of the Nephrology Partnership for Advancing Technology in Healthcare (N-PATH) project, the first European-wide advanced training course in diagnostics and interventional nephrology, funded by Erasmus+ Knowledge Alliance, a European Commission program. The N-PATH primary goal was to train 40 young European nephrologists in both theoretical knowledge and practical skills related to interventional nephrology. The REVAC module focused on the crucial aspects of vascular access (VA) care in nephrology practice, as a complementary training path to the actual residency program. The aim was to provide nephrology fellows with comprehensive knowledge and skills related to VA management. The methodology was based on face-to-face meetings and online learning, modern facilities, experienced tutors, cutting edge simulators, augmented reality tools by means of a multidisciplinary international faculty and hands-on-courses. A feedback survey reported the experience of fellows who attended the REVAC module, confirming the positive impact on their ongoing nephrology training. We are confident that this project will revitalize their nephrology careers and will help training the next generation of nephrologists; they will be able to manage VA needs with the help of multi-disciplinary teams to safely optimize the care of hemodialysis patients.

4.
Resusc Plus ; 19: 100714, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39104444

ABSTRACT

Background: Obtaining intravenous access in hypotensive patients is challenging and may critically delay resuscitation. The Graduated Vascular Access for Hypotensive Patient (GAHP) protocol leverages intraosseous fluid boluses to specifically dilate proximal veins. This study aims to evaluate the efficacy of GAHP in maximizing venous targets through early distal intraosseous access and a small fluid bolus. Methods: This was a prospective randomized cadaveric pilot study to evaluate extremity venous engorgement during intraosseous infusion. Cadavers (n = 23) had an intraosseous needle inserted into four sites: distal radius, proximal humerus, distal femur, and distal tibia. Intraosseous saline was rapidly infused, venous optimization was measured using real-time ultrasound. Primary outcome was maximum vessel circumference increase with intraosseous infusion. Secondary outcomes were: time to maximum circumference, and infusion volume required. Statistical analyses included Levene's test for equality of variances, Wilcoxon signed-rank test, and generalized estimating equation. Results: There was a significant mean increase of 1.03 cm (95% CI 0.86, 1.20), representing a difference of 102%. We found no significant difference in time to optimize vessel circumference across sites, but volume required significantly differed. Conclusion: GAHP quickly and effectively increased the circumference of anatomically adjacent veins. Anatomical sites did not differ on time to reach maximum enlargement of vessels following intraosseous infusion but did differ in terms of volume required to maximize vessel circumference. Further research is needed using live, hypotensive patients.

5.
Infect Dis Health ; 2024 Aug 05.
Article in English | MEDLINE | ID: mdl-39107205

ABSTRACT

BACKGROUND: Peripheral venous catheters (PVCs) remain the primary mode of short-term venous access for managing intravenous fluid, obtaining blood samples, and peripheral parenteral nutrition. They may get contaminated and require regular monitoring to prevent complications. This study evaluated the occurrence of phlebitis and its associated-clinical and microbiological indicators. METHODS: The frequency of phlebitis was evaluated in hospitalized patients of both medical and surgical fields. Subsequently, the dichotomous association between the presence of phlebitis and the clinical aspects was investigated. In parallel, the bacterial contamination of PVCs was assessed through culture-based methods, microscopy observation, and 16S rRNA gene sequencing. RESULTS: Approximately one in four patients presented phlebitis (28.4%). The most frequent symptom was erythema at access site, with or without pain, corresponding to Score 1 on the phlebitis scale (17.9%). Colonization of both lumen and external surface of PVC was observed in 31.3% of the samples. Staphylococcus and Pseudomonas were the most isolated bacterial genera on the PVC surface. No significant association was observed between the presence of phlebitis and the clinical aspects, as well as the presence of microorganisms. CONCLUSION: Microorganism were present on both internal and external PVC surface, without being associated to phlebitis.

6.
J Vasc Access ; : 11297298241273651, 2024 Aug 16.
Article in English | MEDLINE | ID: mdl-39149909

ABSTRACT

The construction and utilization of dependable vascular access are essential for hemodialysis. Despite its importance, complications with vascular access are common, significantly impacting patient morbidity and mortality. This report presents a novel approach to treating chronic total occlusion (CTO) in hemodialysis vascular access using the "wire kissing technique" an "externalization and pull-through technique." An 82-year-old woman on hemodialysis had a thrombotic obstruction in her cephalic vein, which conventional methods failed to address. The wire kissing technique allowed the meeting of antegrade and retrograde wires within the CTO lesion, stabilizing the wire and facilitating balloon passage. The externalization and pull-through technique further enabled the balloon to cross the rigid CTO lesion, successfully completing percutaneous transluminal angioplasty (PTA). Post-procedure ultrasonography showed significant improvements in flow volume and resistance index. These techniques, commonly used in coronary and femoral arteries, have not been previously reported for dialysis vascular access. This case highlights a novel and effective solution for overcoming technical difficulties in crossing CTO lesions, potentially improving outcomes in vascular access for hemodialysis patients.

8.
J Clin Med ; 13(15)2024 Jul 30.
Article in English | MEDLINE | ID: mdl-39124736

ABSTRACT

Background: The transfemoral (TF) approach is the most common route in TAVI, but it is still associated with a risk of bleeding and vascular complications. The aim of this study was to compare the clinical outcomes between surgical cut-down (SC) and percutaneous (PC) approach. (2) Methods: Between January 2018 and June 2022, 774 patients underwent a transfemoral TAVI procedure. After propensity matching, 323 patients underwent TAVI in each group. (3) Results: In the matched population, 15 patients (4.6%) in the SC group vs. 34 patients in the PC group (11%) experienced minor vascular complications (p = 0.02), while no difference for major vascular complication (1.5% vs. 1.9%) were reported. The rate of minor bleeding events was higher in the percutaneous group (11% vs. 3.1%, p <.001). The SC group experienced a higher rate of non-vascular-related access complications (minor 8% vs. 1.2%; major 2.2% vs. 1.2%; p < 0.001). (4) Conclusions: SC for TF-TAVI did not alter the mortality rate at 30 days and was associated with reduced minor vascular complication and bleeding. PC showed a lower rate of non-vascular-related access complications and a lower length of stay. The specific approach should be tailored to the patient's clinical characteristics.

9.
Vascular ; : 17085381241273147, 2024 Aug 12.
Article in English | MEDLINE | ID: mdl-39132802

ABSTRACT

OBJECTIVE: To describe clinical outcomes associated with the use of the WRAPSODY Cell-Impermeable Endoprosthesis at a tertiary center in Western Australia. METHODS: Patients with recalcitrant occlusive disease in the venous outflow of their arteriovenous access circuits were treated with WRAPSODY. Patients were prospectively followed up to 12-month post-procedure. Study measures included 30-day adverse events, technical success, target lesion primary patency, access circuit primary patency, and assisted access circuit primary patency. RESULTS: Twenty-seven WRAPSODY devices were used to treat 15 consecutive patients. The technical success rate was 100%. No device-related adverse events were observed during the follow-up period. Two patients did not complete the full follow up. Patency rates at 3-, 6-, and 12 months for target lesion primary patency were 100% (15/15), 100% (15/15), and 100% (13/13), respectively. Rates for access circuit primary patency at 3-, 6-, and 12 months were 73.3% (11/15), 46.7 % (7/15), and 46.2% (6/13), respectively. Edge stenosis was observed in 33.3% (5/15) of cases and accounted for 5 of the 8 patients who experienced failed access circuit primary patency on angiogram. Primary assisted functional patency was 100% at 12 months. CONCLUSION: WRAPSODY can be utilized safely and has durable patency in real-world patients with complex anatomical renal access stenotic lesions. The therapeutic benefits associated with the device may encourage broader use in clinical practice.

10.
Int J Surg Case Rep ; 122: 110165, 2024 Aug 13.
Article in English | MEDLINE | ID: mdl-39142190

ABSTRACT

INTRODUCTION AND IMPORTANCE: Hemodialysis is the most prevalent type of Renal Replacement Therapy in end stage renal disease patients. Arterio-venous fistulas/grafts and central venous catheters are the most prevalent vascular accesses. But in some patients these options are not feasible because of different reasons. In such cases arterio-arterial grafts may be a viable option to provide vascular access. In this study we present a case of axillary artery arterio-arterial graft. CASE PRESENTATION: A 66-year-old patient was scheduled for arterio-arterial graft implantation following failure of multiple previous vascular accesses. An 8 mm ringed PTFE graft was implanted in loop fashion subcutaneously in left anterior chest wall and anastomosed to transected ends of the axillary artery. Post-operative period was unremarkable and the graft was used for hemodialysis successfully for a period of 8 months. CLINICAL DISCUSSION: Arterio-arterial grafts can provide a flow rate up to 400 ml per minute for hemodialysis. Although the risk of steal syndrome is minimal in this form of vascular access, but the risk of limb ischemia following graft thrombosis should be considered. CONCLUSION: Arterio-arterial grafts may be the only available option for continued hemodialysis in some patients and any vascular surgeon should be familiar with this type of vascular access.

11.
Resusc Plus ; 19: 100694, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39006134

ABSTRACT

Umbilical vascular catheterization remains an important technique in case a newly born infant requires resuscitation. Most textbooks recommend a complete transection of the umbilical cord and subsequent opening of vessel lumen with an iris forceps to place the catheter. That method, however, is challenging in emergencies. Here we present an easy, quick and safe method of placing the umbilical catheters. The side-entry method could be an alternative to the conventional approach and is worth to enter pediatric textbooks and neonatal resuscitation guidelines.

12.
Cureus ; 16(6): e62298, 2024 Jun.
Article in English | MEDLINE | ID: mdl-39006556

ABSTRACT

BACKGROUND: Arteriovenous fistula (AVF) is the vascular access of choice for hemodialysis in end-stage renal disease (ESRD) patients but has a significant failure rate. Atherosclerotic cardiovascular disease (ASCVD) is a major cause of mortality in ESRD patients. Atherosclerosis of the peripheral vessels may contribute to poor maturation of AVF leading to the exploration of the ASCVD score as a prognostic tool for AVF failure. METHODS: This study included 110 hemodialysis patients with AVFs and aimed to examine the association between ASCVD score and AVF failure. Participants were categorized into the presence of vascular access failure (N=12) and absence of vascular access failure (N=98), and demographic and clinical data were collected.  Results: The study comprised predominantly male patients (63.6%), with a notable prevalence of hypertension and diabetes. Twelve patients experienced AVF failure, with pseudoaneurysms and thrombosis being the predominant causes. The ASCVD risk group at intermediate and high stages exhibited a statistically significant risk (relative risk (RR)=1.403; 95% CI, 1.041-1.904) of AVF failure in comparison to the low and borderline ASCVD risk groups. There was no association of age, gender (male and female), body mass index (BMI), serum calcium, serum phosphorus, intact parathyroid hormone (iPTH), and serum albumin with AVF failure. CONCLUSION: The ASCVD score emerges as a potential prognostic tool to identify dialysis patients at high risk of AVF failure, suggesting avenues for targeted interventions and improved patient care. However, limitations of the ASCVD risk estimator and study limitations, such as small sample size and absence of mortality data, warrant cautious interpretation and necessitate further exploration in larger patient populations.

13.
Article in English | MEDLINE | ID: mdl-39004562

ABSTRACT

INTRODUCTION: The installation of an arterial line is one of the invasive procedures performed for hemodynamic monitoring and, even with its clear importance in intensive care, it is still an invasive procedure and liable to cause harms to the patients. OBJECTIVE: To identify the adverse events associated with the use of arterial catheters in critically-ill patients in the world scientific production. METHODOLOGY: The present scoping review was conducted according to the JBI methodology for scoping reviews. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist was used for reporting. The research question was "Which adverse events related to the use of arterial catheters in patients admitted to intensive care are more evident in the literature?". Data collection took place in the following databases: LILACS; MEDLINE; EMBASE; CINAHL, EBSCOhost; and WEB OF SCIENCE. RESULTS: Through the search strategies, 491 articles were found in the databases. After exclusion of duplicates, peer analysis of titles and abstracts, full reading and screening of lists of references, the final sample of studies included was 38 articles. The main harms cited by the publications were as follows: limb ischemia, thrombosis, hemorrhage, accidental removal, inadvertent connection of inadequate infusion solution, pseudoaneurysm and bloodstream infection. CONCLUSIONS: It was evidenced that patients are subjected to risks of adverse events from the insertion moment to removal of the arterial catheter, focusing on the infusion solution used to fill the circuit, the type of securement and dressings chosen, as well as the Nursing care measures for the prevention of bloodstream infection.

14.
Nurs Open ; 11(7): e2177, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38967938

ABSTRACT

AIM: To develop and psychometrically test an instrument to assess nurses' evidence-based knowledge and self-efficacy regarding insertion and management of venous access devices (short peripheral catheter (SPC), long peripheral catheter/midline (LPC) and PICC) and the management of totally implantable central venous catheter (Port) in adult patients. DESIGN: Multicenter cross-sectional observational study with questionnaire development and psychometric testing (validity and reliability). METHODS: An evidence-based instrument was developed including a 34-item knowledge section and an 81-item self-efficacy section including four device-specific parts. Nineteen experts evaluated content validity. A pilot study was conducted with 86 nurses. Difficulty and discrimination indices were calculated for knowledge items. Confirmatory factor analyses tested the dimensionality of the self-efficacy section according to the development model. Construct validity was tested through known group validity. Reliability was evaluated through Cronbach's alpha coefficient for unidimensional scales and omega coefficients for multidimensional scales. RESULTS: Content validity indices and results from the pilot study were excellent with all the item-content validity indices >0.78 and scale-content validity index ranging from 0.96 to 0.99. The survey was completed by 425 nurses. Difficulty and discrimination indices for knowledge items were acceptable with most items (58.8%) showing desirable difficulty and most items (58.8%) with excellent (35.3%) or good (23.5%) discrimination power, and appropriate to the content. The dimensionality of the model posited for self-efficacy was confirmed with adequate fit indices (e.g., comparative fit index range 0.984-0.996, root mean square error of approximation range 0.054-0.073). Construct validity was determined and reliability was excellent with alpha values ranging from 0.843 to 0.946 and omega coefficients ranging from 0.833 to 0.933. Therefore, a valid and reliable tool based on updated guidelines is made available to evaluate nurses' competencies for venous access insertion and management.


Subject(s)
Psychometrics , Self Efficacy , Humans , Surveys and Questionnaires , Cross-Sectional Studies , Female , Adult , Male , Reproducibility of Results , Psychometrics/instrumentation , Psychometrics/standards , Pilot Projects , Clinical Competence/standards , Nurses/psychology , Health Knowledge, Attitudes, Practice , Middle Aged , Catheterization, Central Venous/nursing , Catheterization, Central Venous/standards , Vascular Access Devices
15.
Nephrology (Carlton) ; 2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39022890

ABSTRACT

Depletion of veins for dialysis access is a challenging life threatening situation for patients in need of haemodialysis. The utilisation of intracardiac catheter is a rare procedure with scarce reported experience. We describe the case of a 68-year-old male that contributes to the limited knowledge of performing a life-saving intracardiac catheter placement for emergency haemodialysis in a patient without immediate alternative renal replacement therapy available. We also retrospectively analyse the experience reported so far and summarise complications and outcomes. In our case, the patient was able to pursue haemodialysis after intracardiac catheter placement without any complications. Two weeks later, the patient successfully received a kidney transplant from a deceased donor and has a serum creatinine of 1.7 mg/dL after 2 years of follow-up. There are only four reported cases of kidney transplantation after the procedure, including our own. Intracardiac catheter is an emerging option that could be considered in certain patients as the last resort. Further investigation with regards to patient candidacy and procedure security are necessary.

16.
Br J Nurs ; 33(14): S25-S29, 2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39023019

ABSTRACT

BACKGROUND: The significance of vascular access devices for patients in the emergency department (ED) is undeniable. When it comes to evaluating the effectiveness of interventions, randomised controlled trials (RCTs) stand out as the most reliable sources of evidence compared with other study designs. AIM: To explore and synthesise the findings from RCTs related to vascular access devices in the ED setting. METHODS: A systematic search will be conducted in electronic medical databases including the Cochrane Central Register of Controlled Trials, Pubmed, CINAHL and Embase databases. All RCTs focusing on peripheral intravenous catheters, central venous catheters and intraosseous catheters, published in English and Chinese in peer-reviewed journals within the past decade, will be included. CONCLUSION: This scoping review will summarise the current state of evidence for vascular access devices in the ED setting. This will identify gaps in the literature and, in turn, assist clinicians and researchers in pinpointing areas for future exploration and provide a valuable guide for future research.


Subject(s)
Emergency Service, Hospital , Randomized Controlled Trials as Topic , Vascular Access Devices , Humans , Catheterization, Peripheral/instrumentation , Catheterization, Peripheral/methods , Review Literature as Topic
17.
J Nephrol ; 2024 Jul 30.
Article in English | MEDLINE | ID: mdl-39080223

ABSTRACT

BACKGROUND: International guidelines issued recommendations for vascular access (VA) care for hemodialysis, but there are no registry data regarding this topic in Italy. METHODS: A survey consisting of 17 items was sent to all Italian dialysis wards, via the Italian Society of Nephrology (SIN) website, from April to June 2021. The items were defined, discussed and approved by experts in vascular access management within the Italian Society of Nephrology. A total of 124 dialysis units answered, accounting for 14% of all dialysis units. The survey thus encompasses all regions within the country, with some regional variations in terms of adherence. RESULTS: One hundred twenty-four facilities provided data, regarding 12,276 patients: 61% had an arteriovenous fistula (AVF), 34% had a central venous catheter (CVC), and 5% had an arteriovenous graft (AVG). Among them, two-thirds of the facilities reported having a vascular access care pathway, formally standardized in 79% of cases. Forty-six % of centers had a fully equipped vascular access care pathway, encompassing preoperative mapping (80%), vascular access setup (71%), arteriovenous fistula maturation monitoring (76%), first-level (80%) and second-level (78%) monitoring, and surgical and/or endovascular treatment of complications (66%). Vascular access monitoring was computerized in 39% of facilities. First-level monitoring (physical examination) was primarily done by nurses in two-thirds of facilities. Of note, 45% of centers had nurses who were skilled in ultrasound-guided cannulation. Quite surprisingly, facilities with less than 100 patients had a greater prevalence of arteriovenous fistulas than those with more than 100 patients (p = 0.0023). A protocolled vascular access care pathway was associated with a higher likelihood of having an arteriovenous fistula (70% AVF vs 42,1% CVC; p = 0.04). The presence in the facility of interventional nephrologists or nurses with ultrasound-guided cannulation skills significantly reduced the prevalence of central venous catheters. CONCLUSION: These survey data further strengthen the need for formal and shared vascular access monitoring protocols.

18.
Ann Vasc Surg ; 2024 Jul 24.
Article in English | MEDLINE | ID: mdl-39059630

ABSTRACT

PURPOSE: This study aims to assess the efficacy and complications associated with upper limb catheterization during complex aneurysm endovascular surgery repair. METHODS: A systematic review was conducted following PRISMA guidelines, involving a search across PubMed, Cochrane CENTRAL, and Web of Science. Primary endpoint was represented by 30-day stroke. Secondary endpoints were target vessels technical success, 30-day mortality, local access-related complications. Meta-analyses were performed using a random-effects model. RESULTS: Sixteen observational studies encompassing 4,137 patients were included. The 30-day stroke incidence for upper limb access was 1.4% (95% CI 1.0%-1.8%), slightly higher than lower limb, despite not statistically significant. Mortality varied between 0-6.8%, and local access-related complications occurred in 3.2% (95% CI 1.9%-4.4%). Technical success in target vessel catheterization was 99.2% (95% CI 98.4%-100.0%). CONCLUSION: This systematic review and meta-analysis demonstrate the safety and efficacy of upper limb access for f/b-EVAR, with low stroke risk, mortality rates, and minimal local complications. Despite the risk of bias, the findings suggest that upper limb access may be beneficial, especially in bailout situations when femoral access fails, offering valuable insights for clinical decision-making.

19.
Antibiotics (Basel) ; 13(7)2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39061346

ABSTRACT

BACKGROUND: The aim of the study was to characterize the procedure of peripheral intravenous therapy (IT), including the characteristics of vascular access and related complications and qualitative and quantitative analyses of drug consumption. MATERIALS AND METHODS: A two-year, retrospective, single-center observational study was conducted. The criterion for including a patient in the study was the use of peripheral intravenous catheters (PIVCs) upon admission or during the stay at the internal medicine department (IMD). RESULTS: The main reasons for hospitalization were exacerbations of chronic diseases for 78% of the patients and acute infections for 22%. IT was used in 83.6% of all the patients. IT was used primarily for antibiotics (5009.9 defined daily doses (DDD)). Further, 22.6% of the PIVCs stopped functioning within 24 h, more frequently in infectious patients. The main reasons for PIVC removal were leakage (n = 880, 26.6%) and occlusion (n = 578, 17.5%). The PIVC locations were mostly suboptimal (n = 2010, 59.5%), and such locations were related to leakage and occlusion (p = 0.017). CONCLUSIONS: In the IMD, most patients require the use of a PIVC, and antibiotics dominate the group of drugs administered intravenously. Up to 1/5 of peripheral intravenous catheters are lost within the first 24 h after their insertion, with most of them placed suboptimally. A properly functioning PIVC appears to be crucial for antimicrobial treatment.

20.
Cardiovasc Intervent Radiol ; 47(8): 1057-1065, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38955816

ABSTRACT

PURPOSE: To evaluate the safety and performance of Wrapsody™, a cell-impermeable endoprosthesis (CIE), for treating hemodialysis vascular access outflow stenosis. MATERIALS AND METHODS: Investigators retrospectively analyzed 113 hemodialysis patients treated with a CIE (11/2021-12/2022) across four centers in Brazil. De novo or restenotic lesions were treated. The primary efficacy outcome measure was target lesion primary patency (TLPP) at 1, 3, 6, and 12 months; the primary safety outcome measure was the absence of serious local or systemic adverse events within the first 30 days post-procedure. Secondary outcome measures included technical and procedural success, access circuit primary patency (ACPP), and secondary patency at 1, 3, 6, and 12 months post-procedure. RESULTS: Thirty-nine patients (34.5%) had thrombosed access at the initial presentation, and 38 patients (33.6%) presented with recurrent stenosis. TLPP rates at 1, 3, 6, and 12 months were 100%, 96.4%, 86.4%, and 69.7%, respectively. ACPP rates were 100% at 1 month, 89.2% at 3 months, 70.9% at 6 months, and 56.0% at 12 months. The target lesion secondary patency rates at 1, 3, 6, and 12 months were 100%, 97.3%, 93.6%, and 91.7%, respectively. In the adjusted multivariate Cox regression analysis, male sex and endoprosthesis with diameters of 10, 12, 14, and 16 mm were associated with improved primary patency rates. No localized or systemic serious adverse event was observed through the first 30 days post-procedure. CONCLUSION: The CIE evaluated in this study is safe and effective for treating peripheral and central outflow stenoses in hemodialysis vascular access. LEVEL OF EVIDENCE: Level 2b, cohort study.


Subject(s)
Graft Occlusion, Vascular , Renal Dialysis , Vascular Patency , Humans , Retrospective Studies , Male , Female , Middle Aged , Brazil , Aged , Graft Occlusion, Vascular/therapy , Constriction, Pathologic , Treatment Outcome , Arteriovenous Shunt, Surgical , Blood Vessel Prosthesis , Adult
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