RESUMEN
BACKGROUND: In 2019, Bard Peripheral Vascular Inc (BV; now Becton, Dickinson and Company; Sparks, Maryland) received Food and Drug Administration (FDA) approval to begin marketing the WavelinQ EndoAVF System through a process known as 510(k) authorization. Such authorization relies on BV proving that the new WavelinQ EndoAVF System was of "substantial equivalence" to the WavelinQ 4F EndoAVF System. We set forth to analyze patient problems and device issues reported for the new device and determine if they were significantly different from the predicate device its 510(k) approval was based on. METHODS: FDA database Manufacturer and User Facility Device Experience was queried for all adverse report events for the WavelinQ EndoAVF System and WavelinQ 4F EndoAVF System. Data were collected on patient issues and device issues. Fisher's exact test was used. RESULTS: There were a total of 125 reports for the WavelinQ 4F EndoAVF System and 78 for the WavelinQ EndoAVF System. There was a significant increase in patient problem "hypertension" (0% vs. 5.1%; P = 0.02) for the WavelinQ EndoAVF System but a statistically significant decrease in device issue "failure to align" for the WavelinQ EndoAVF System (24.8% vs. 10.3%; P ≤ 0.01). CONCLUSIONS: There were changes in device and patient outcomes between the WavelinQ EndoAVF System and WavelinQ 4F EndoAVF System. While we noted a decrease in device problem "failure to align", there was an overall increase in patients' "hypertension" rates. This highlights the importance of the FDA Manufacturer and User Facility Device Experience reporting in ensuring that device safety is maintained when devices are approved for marketing through the 510(k) process.
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Derivación Arteriovenosa Quirúrgica , Bases de Datos Factuales , Aprobación de Recursos , Procedimientos Endovasculares , Diseño de Prótesis , United States Food and Drug Administration , Humanos , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversos , Estados Unidos , Derivación Arteriovenosa Quirúrgica/efectos adversos , Derivación Arteriovenosa Quirúrgica/instrumentación , Prótesis Vascular , Resultado del Tratamiento , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/efectos adversos , Diálisis Renal , Factores de RiesgoRESUMEN
BACKGROUND: This review will discuss the use of distal adjuncts for improving graft patency in high-risk lower extremity bypasses. METHODS: Factors that contribute to the increased risk of failure in high-risk lower extremity bypasses, such as the use of nonautogenous conduits, the creation of bypasses to very distal arterial targets, and bypasses in patients with significant tibial arterial disease, will be discussed. RESULTS: The use of surgical techniques such as creating venous cuffs, venous patches, and arteriovenous fistulas have been shown to improve the patency of high-risk bypasses. CONCLUSIONS: Despite the increased risk of failure, the use of surgical adjuncts such as cuffs, patches, and arteriovenous fistulas can improve the patency rates of high-risk lower extremity bypasses.
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Extremidad Inferior , Enfermedad Arterial Periférica , Grado de Desobstrucción Vascular , Humanos , Extremidad Inferior/irrigación sanguínea , Factores de Riesgo , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/fisiopatología , Enfermedad Arterial Periférica/diagnóstico por imagen , Resultado del Tratamiento , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/fisiopatología , Derivación Arteriovenosa Quirúrgica/efectos adversos , Derivación Arteriovenosa Quirúrgica/instrumentación , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/efectos adversos , Medición de RiesgoRESUMEN
OBJECTIVE: Hemodialysis patients usually receive an arteriovenous fistula (AVF) in the arm as vascular access conduit to allow dialysis 2-3 times a week. This AVF introduces the high flow necessary for dialysis, but over time the ever-present supraphysiological flow is the leading cause of complications. This study aims to develop an implantable device able to non-invasively remove the high flow outside dialysis sessions. METHODS: The developed prototype features a magnetic ring allowing external coupling and torque transmission to non-invasively control an AVF valve. Mock-up devices were implanted into arm and sheep cadavers to test sizes and locations. The transmission torque, output force, and valve closure are measured for different representative skin thicknesses. RESULTS: The prototype was placed successfully into arm and sheep cadavers. In the prototype, a maximum output force of 78.9 ± 4.2 N, 46.7 ± 1.9 N, 25.6 ± 0.7 N, 13.5 ± 0.6 N and 6.3 ± 0.4 N could be achieved non-invasively through skin thicknesses of 1-5 mm respectively. The fistula was fully collapsible in every measurement through skin thickness up to the required 4 mm. CONCLUSION: The prototype satisfies the design requirements. It is fully implantable and allows closure and control of an AVF through non-invasive torque transmission. In vivo studies are pivotal in assessing functionality and understanding systemic effects. SIGNIFICANCE: A method is introduced to transfer large amounts of energy to a medical implant for actuation of a mechanical valve trough a closed surface. This system allows non-invasive control of an AVF to reduce complications related to the permanent high flow in conventional AVFs.
Asunto(s)
Derivación Arteriovenosa Quirúrgica , Animales , Ovinos , Derivación Arteriovenosa Quirúrgica/instrumentación , Diseño de Equipo , Torque , Diálisis Renal/instrumentación , Diálisis Renal/métodosRESUMEN
OBJECTIVE: It is unclear whether tapered arteriovenous grafts (AVGs) are superior to non-tapered AVGs when it comes to preventing upper extremity ischemic steal syndrome. We aimed to evaluate the outcomes of tapered and non-tapered AVGs using systematic review and meta-analysis. METHODS: A literature search was systemically performed to identify all English publications from 1999 to 2019 that directly compared the outcomes of upper extremity tapered and non-tapered AVGs. Outcomes evaluated were the primary patency at 1-year (number of studies (n) = 4), secondary patency at 1-year (n = 3), and risk of ischemic steal (n = 5) and infection (n = 4). Effect sizes of individual studies were pooled using random-effects model, and between-study variability was assessed using the I2 statistic. RESULTS: Of 5808 studies screened, five studies involving 4397 patients have met the inclusion criteria and included in the analysis. Meta-analyses revealed no significant difference for the risk of ischemic steal syndrome (pooled odds ratio (OR) 0.92, 95% Confidence Incidence (CI) 0.29-2.91, p = 0.89, I2 = 48%) between the tapered and non-tapered upper extremity AVG. The primary patency (OR 1.33, 95% CI 0.93-1.90, p = 0.12, I2 = 10%) and secondary patency at 1-year (OR 1.49, 95% CI 0.84-2.63, p = 0.17, I2 = 13%), and rate of infection (OR 0.62, 95% CI 0.30-1.27, p = 0.19, I2 = 29%) were also similar between the tapered and non-tapered AVG. CONCLUSIONS: The risk of ischemic steal syndrome and patency rate are comparable for upper extremity tapered and non-tapered AVGs. This meta-analysis does not support the routine use of tapered graft over non-tapered graft to prevent ischemic steal syndrome in upper extremity dialysis access. However, due to small number of studies and sample sizes as well as limited stratification of outcomes based on risk factors, future studies should take such limitations into account while designing more robust protocols to elucidate this issue.
Asunto(s)
Derivación Arteriovenosa Quirúrgica , Implantación de Prótesis Vascular , Diálisis Renal , Derivación Arteriovenosa Quirúrgica/instrumentación , Implantación de Prótesis Vascular/efectos adversos , Oclusión de Injerto Vascular/etiología , Humanos , Estudios Retrospectivos , Factores de Riesgo , Extremidad Superior , Grado de Desobstrucción VascularRESUMEN
OBJECTIVE: Arteriovenous grafts (AVGs) are frequently needed in hemodialysis (HD) patients with unsuitable superficial veins. First cannulation of standard arteriovenous grafts (sAVGs) still require about 2 weeks after implantation. Early cannulation arteriovenous grafts (eAVGs) were suggested to overcome this shortcoming. The present randomized study proposed to compare the clinical outcomes of sAVGs and eAVGs in HD patients. METHODS: The present single-center randomized clinical study recruited 477 HD patients indicated for AVG creation. They included 236 in the sAVG group and 241 in the eAVG group. Eligible patients were simply randomized and allocated to the studied groups using 1:1 allocation ratio. Blinding was secured using the sealed envelope technique. Enrolled patients were followed up for 12 months. The primary outcome in the present study was primary, primary assisted, and secondary patency rates at 12 months. Other outcome parameters included time to first cannulation, graft complications, and mortality. RESULTS: Comparison between the studied groups regarding the primary outcomes revealed no statistically significant differences. Primary patency rate was 65.7% and 68.0% (P = .58) at 6 months and 53.8% and 56.4% (P = .57) at 12 months in the sAVG and eAVG groups, respectively. Primary assisted patency rate was 70.8% and 69.7% (P = .8) in patients with sAVG and eAVG, whereas the reported rates at 12 months were 59.3% and 61.0% (P = .71), respectively. Secondary patency rate was 78.4% and 73.9% (P = .25) at 6 months and 67.8% and 69.7% (P = .65) at 12 months in the sAVG and eAVG groups, respectively. As expected, patients in the eAVG group experienced significantly earlier cannulation when compared with patients in the sAVG group (median, 3.0 days; range, 1.0-9.0 days vs 19.0 days; range, 15.0-22.0 days; P < .001). CONCLUSIONS: Patients in the eAVG group have comparable outcomes to those in the sAVG group at 12 months with the added advantage of earlier time to first cannulation.
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Derivación Arteriovenosa Quirúrgica , Implantación de Prótesis Vascular , Cateterismo , Diálisis Renal , Adulto , Derivación Arteriovenosa Quirúrgica/efectos adversos , Derivación Arteriovenosa Quirúrgica/instrumentación , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Cateterismo/efectos adversos , Egipto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Politetrafluoroetileno , Diseño de Prótesis , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Percutaneous devices for creation of native arteriovenous fistulae offer an alternative to traditional open surgical techniques. The 4F WavelinQ EndoAVF System was developed as a lower profile alternative to facilitate access through smaller vessels and minimize access site complications; The current report is the original first experience of this device, assessing outcome in 120 patients followed for 6 months. METHODS: The use of the 4F WavelinQ system in three studies, EASE (32 patients), EASE-2 (24 patients), and the EU postmarket clinical follow-up study (64 patients) was aggregated and analyzed. Patients were followed with duplex ultrasound at discharge and follow-up visits at 1, 3, and 6 months. Primary, assisted primary, and secondary patency rates were evaluated as Kaplan-Meier estimates and standard errors. Time to maturity and time to successful cannulation were defined as the mean ± standard deviation days from the procedure in patients enrolled on dialysis. RESULTS: Procedural success was achieved in 116 patients (96.7%). Primary, assisted-primary, and secondary 6-month patency rates were 71.9% ± 4.5%, 80.7% ± 4.1%, and 87.8% ± 3.3%, respectively. Time to maturity averaged 41 ± 17 days. Time to successful cannulation averaged 68 ± 51 days. Device-related serious adverse events were reported in 3 of 120 patients (2.5%) and procedure-related serious adverse events occurred in 7 of 120 patients (5.8%). Arterial or venous access complications were not reported in any of the patients. Access circuit reinterventions were performed in 23 patients (19.2%), split between those performed for EndoAVF maturation (13/120 [10.8%]) and maintenance (11/120 [9.2%]). CONCLUSIONS: Percutaneous creation of native dialysis fistulae with the 4F WavelinQ EndoAVF System is safe and effective, with favorable durability and a low rate of serious complications and reinterventions through 6-month follow-up. Use of the 4F device allows for percutaneous fistula creation between the radial artery and radial vein or the ulnar artery and ulnar vein. These findings suggest that the 4F device is a useful percutaneous alternative to open surgical AVF or endovascular AVF with larger bore devices.
Asunto(s)
Derivación Arteriovenosa Quirúrgica/instrumentación , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Diálisis Renal , Insuficiencia Renal Crónica/terapia , Extremidad Superior/irrigación sanguínea , Adulto , Anciano , Anciano de 80 o más Años , Derivación Arteriovenosa Quirúrgica/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Ensayos Clínicos como Asunto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Arteria Radial/cirugía , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Arteria Cubital/cirugía , Ultrasonografía Doppler Dúplex , Grado de Desobstrucción Vascular , Adulto JovenRESUMEN
BACKGROUND: In patients without suitable vasculature for autologous arteriovenous fistula, vascular access using a prosthetic graft is an option for hemodialysis. Gore® ACUSEAL Vascular graft is an early cannulation arteriovenous graft (AVG) that allows early puncture within 24 h after surgery. We aimed to report the outcomes of using this graft in patients from a single center. METHODS: This study included 113 patients who underwent surgery for a new AVG using ACUSEAL, between December 2015 and December 2017, and were followed up. The primary outcomes were primary patency, assisted-primary patency, and secondary patency. Secondary outcomes were postoperative complications such as graft infection and steal syndrome. RESULTS: Of the 113 patients, 60 were male and 53 were female. The average age was 74.4 ± 10.7 years. We could cannulate 69.1% of patients within 24 h. The average follow-up period was 20.1 ± 10.8 months. The primary patency rates after 3 months, 6 months, and 1 year were 76.2%, 60.4%, and 33.8%, respectively. The assisted-primary patency rates after 3 months, 6 months, and 1 year were 88.8%, 73.2%, and 58.9%, respectively. The secondary patency rates after 3 months, 6 months, and 1 year were 100%, 100%, and 98.8%, respectively. Fourteen patients (12.4%) developed graft infection and two patients (1.8%) developed steal syndrome. CONCLUSION: In our study, ACUSEAL showed satisfactory patency and acceptable complication rates in the short to medium term, similar to previous studies. ACUSEAL is beneficial for surgeons who are familiar with using AVG and for medical staff who control bleeding after dialysis. However, due to the large outer diameter of the graft, surgical wounds might become dehiscent, and careful designing of the subcutaneous graft route is necessary. It might be possible to reduce the rate of graft infection by planning the site and skin incision.
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Derivación Arteriovenosa Quirúrgica , Implantación de Prótesis Vascular , Diálisis Renal , Anciano , Anciano de 80 o más Años , Derivación Arteriovenosa Quirúrgica/instrumentación , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Femenino , Humanos , Japón , Masculino , Persona de Mediana Edad , Factores de Tiempo , Resultado del TratamientoRESUMEN
This prospective study compared methods using both arterial and venous needles with back eyes with those using only arterial needle with back eye for arteriovenous fistula cannulation. Sixty-one patients receiving hemodialysis (HD) via an arteriovenous fistula were evaluated. All patients underwent arteriovenous fistula puncture using only arterial needle with back eye in first 3 months and both arterial and venous needles with back eyes in following 3 months. Arterial and venous pressures, blood flow velocities, total blood volume cleared, and Kt/V values were compared. Mean blood flow velocity, arterial pressure, Kt/V, and cleared total blood volume values were higher and venous pressure was lower in patients who underwent cannulation using both needles with back eyes than in those with only the arterial needle with back eye. For arteriovenous fistula cannulation, using both arterial and venous needles with back eyes provides adequate HD more successfully.
Asunto(s)
Derivación Arteriovenosa Quirúrgica/instrumentación , Derivación Arteriovenosa Quirúrgica/métodos , Agujas , Punciones/instrumentación , Punciones/métodos , Diálisis Renal/métodos , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
OBJECTIVE: To evaluate the outcomes of arteriovenous fistulae (AVF), created with VasQ external support device under standard clinical practice across three vascular access clinics. METHODS: This multinational, retrospective study evaluated prospectively collected clinical outcomes of both forearm and upper arm brachiocephalic AVF (BCAVF) created using the VasQ device. Fifty-one AVF patients were pooled from three different vascular access centers in Germany, Italy, and Spain. Postprocedure outcomes were assessed by flow measurement with ultrasound examination in all centers. Primary failure, usability, patency, and intervention rates during the study period were evaluated. RESULTS: Fifty-one VasQ devices were implanted during 37 forearm (36 radiocephalic and 1 ulnar-basilic AVF) and 14 BCAVF procedures. The study population comprised mostly males (73%) and Caucasians (82%), with a mean age of 62.5 years (range, 38-84 years) and mean body mass index of 29.2. One patient died owing to access-unrelated reasons, and one patient was lost to follow-up without AVF assessment after its creation. From the remaining 49, 3 patients had a follow-up of less than 4 weeks and were excluded from maturation, primary failure, and dialysis initiation analysis (because those factors could not be evaluated yet), leaving 46 patients in this evaluation. Maturation was achieved in 91% of patients. The primary failure rate was 9%. A primary patency rate of 77% was observed at 6, 12, and 18 months. The secondary patency rate was 91% at 6 months, and 85% at 12 months and 18 months. Both primary patency and secondary patency did not differ statistically when comparing forearm AVF with BCAVF (P > .25). Successful cannulation was achieved in 86% of patients (32/37) requiring dialysis with a median time from creation to cannulation of 46 days. Of those patients, the functional patency rate was 94%. Five patients underwent seven interventions to maintain or restore patency or functionality, with an overall rate of 0.248 interventions per patient-year. CONCLUSIONS: AVFs created with VasQ external support device demonstrated promising patency and functionality outcomes in multicentric real-world setting across the two most commonly used anatomic locations.
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Derivación Arteriovenosa Quirúrgica/instrumentación , Diálisis Renal/métodos , Grado de Desobstrucción Vascular , Adulto , Anciano , Anciano de 80 o más Años , Arteria Braquial/cirugía , Femenino , Estudios de Seguimiento , Antebrazo/irrigación sanguínea , Humanos , Fallo Renal Crónico/terapia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Arteria Radial/cirugía , Diálisis Renal/instrumentación , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
RATIONALE & OBJECTIVE: Percutaneous arteriovenous fistulas (AVF) are created by establishing a proximal forearm anastomosis and offer a safe and reliable vascular access. This study compares the Ellipsys percutaneous AVF with a proximal forearm Gracz-type surgical AVF, chosen for comparison as it is constructed at the same anatomical site. STUDY DESIGN: Retrospective study of prospectively collected clinical data. SETTING & PARTICIPANTS: All vascular access procedures conducted during a 34-month period were reviewed. The study groups comprised 89 percutaneous AVFs and 69 surgical AVFs. EXPOSURE: Percutaneous or surgical AVF placement. OUTCOME: AVF patency, function, and complications. ANALYTICAL APPROACH: Patency rates for each AVF group were evaluated by competing risk survival analysis using a cumulative incidence function. Association of primary, primary assisted, and secondary patency with the AVF groups was examined by Cox proportional hazard models. RESULTS: Technical success was 100% for both groups. Average procedure times were 14 minutes for percutaneous AVFs and 74 minutes for surgical AVFs (P < 0.001). Proximal radial artery (PRA) was used in all percutaneous AVF cases. Inflow for surgical AVFs included radial (30%), ulnar (12%), and brachial (58%) arteries. Outflow veins for both groups were the cephalic and/or basilic veins. Access flow volumes, times to maturation, and overall numbers of interventions per patient-year were not significantly different. Cumulative incidence of primary patency failure at 12 months was lower for surgical AVF (47% vs 64%, P = 0.1), but secondary patency failure was not different between groups (20% vs 12%, P = 0.3). PRA surgical AVFs had similar primary patency (65% vs 64%, P = 0.8) but higher secondary patency failure rates than percutaneous AVFs at 12 months (34% vs 12%, P = 0.04). LIMITATIONS: Retrospective study with a relatively short follow-up period, and not all patients required hemodialysis at the end of study. CONCLUSIONS: Both percutaneous and surgical AVFs demonstrated high rates of technical success and secondary patency. Percutaneous AVFs required shorter procedure times. The rate of intervention was similar. When a distal radial artery AVF is not feasible, percutaneous AVF might offer an appropriate procedure for creating a safe and functional access, maintaining further proximal forearm surgical AVF creation options.
Asunto(s)
Derivación Arteriovenosa Quirúrgica/métodos , Antebrazo/irrigación sanguínea , Fallo Renal Crónico/terapia , Diálisis Renal/métodos , Adulto , Anciano , Anciano de 80 o más Años , Derivación Arteriovenosa Quirúrgica/instrumentación , Arteria Braquial/fisiología , Femenino , Estudios de Seguimiento , Humanos , Fallo Renal Crónico/diagnóstico , Masculino , Persona de Mediana Edad , Arteria Radial/fisiología , Diálisis Renal/instrumentación , Estudios Retrospectivos , Arteria Cubital/fisiología , Grado de Desobstrucción Vascular/fisiologíaRESUMEN
OBJECTIVE: Creation of good long-term arteriovenous access is essential in patients requiring hemodialysis for end-stage renal failure. However, arteriovenous grafts or fistulae can be complicated by infection that may require emergency surgery. For infections that involve the brachial artery anastomosis, or if total graft explantation is indicated, brachial artery repair or reconstruction is often required. An alternative management strategy would be brachial artery ligation (BAL). We performed a systematic review to evaluate the outcomes of BAL that has been performed for infected arteriovenous grafts or fistulae. METHODS: A thorough literature search was conducted using various electronic databases. We included articles that reported outcomes of BAL performed for infected arteriovenous grafts or fistulae. The primary outcome was the incidence of upper limb ischemia after BAL. Secondary outcomes were the need for urgent revascularization, need for upper limb amputation, and incidence of postoperative neurological deficit after BAL. RESULTS: A total of five studies with a total of 125 patients were included in our systematic review. BAL was performed for infected arteriovenous grafts or fistulae for all studies. Follow-up period ranged from 1 to 27 months. The incidence of upper limb ischemia after BAL was low. Only a single study reported three patients who developed upper limb ischemia. Two patients required urgent revascularization, and one patient required forearm amputation after proximal ligation. All studies reported clearance of infection with no recurrence. CONCLUSIONS: Distal BAL may be performed safely for patients with infected arteriovenous fistulae or grafts with low risk of upper limb ischemia, postoperative neurological deficit, and recurrent infection.
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Derivación Arteriovenosa Quirúrgica/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Prótesis Vascular/efectos adversos , Arteria Braquial/cirugía , Infecciones Relacionadas con Prótesis/cirugía , Diálisis Renal , Adulto , Anciano , Anciano de 80 o más Años , Derivación Arteriovenosa Quirúrgica/instrumentación , Implantación de Prótesis Vascular/instrumentación , Femenino , Humanos , Ligadura , Masculino , Persona de Mediana Edad , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/etiología , Reinfección , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVE: The aim of the present study was to compare the results between percutaneous arteriovenous fistulas (p-AVFs) created with the Ellipsys device (Ellipsys Vascular Access System; Avenu Medical, San Juan Capistrano, Calif) and surgical arteriovenous fistulas (s-AVFs). METHODS: A single-center retrospective comparative study of the first 107 patients who had undergone p-AVF creation with the Ellipsys system from May 2017 to May 2018 with an equal number of consecutive patients who had undergone s-AVF creation in our center during the same period. The primary endpoints included the maturation and patency rates. The secondary endpoints were reintervention, risk of infection, and the incidence of steal syndrome and aneurysm formation. RESULTS: The demographic, hypertension, and diabetes data were similar for both groups. The only difference between the two groups was that more p-AVF patients had already been receiving hemodialysis (61% vs 47%; P < .05). The p-AVFs showed superior maturation rates at 6 weeks (65% vs 50%; P = .01). The primary patency rates were greater for the s-AVFs at 12 months (86% vs 61%; P < .01). However, primary patency was comparable between the two groups at 24 months (52% vs 55%; P = .48). No significant difference was found in the secondary patency rates at 12 (90% vs 91%) and 24 (88% vs 91%) months. At the 2-year follow-up point, the rate of percutaneous reintervention was similar; however, the s-AVFs had required more frequent surgical revision (36% vs 17%; P = .01). Issues with wound healing and infection were also more frequent with s-AVFs (9% vs 0.9%; P < .01). CONCLUSIONS: Fistulas created percutaneously with the Ellipsys system showed superior maturation rates and similar patency with s-AVFs created in an experienced high-volume vascular surgery practice. p-AVFs had a lower risk of wound healing issues, infection, and surgical revision. Larger, prospective, randomized multicenter studies are needed to confirm these findings.
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Derivación Arteriovenosa Quirúrgica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Diálisis Renal , Anciano , Aneurisma/etiología , Aneurisma/terapia , Derivación Arteriovenosa Quirúrgica/efectos adversos , Derivación Arteriovenosa Quirúrgica/instrumentación , Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/fisiopatología , Oclusión de Injerto Vascular/terapia , Humanos , Isquemia/etiología , Isquemia/fisiopatología , Isquemia/terapia , Masculino , Persona de Mediana Edad , Infecciones Relacionadas con Prótesis/etiología , Infecciones Relacionadas con Prótesis/terapia , Retratamiento , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Recently, there has been an abundance of encouraging data regarding the creation of percutaneous arteriovenous fistulas. Despite promising data regarding their clinical maturation, a paucity of data exists which provides direct comparison between percutaneously created AVFs (pAVF) and open surgically created AVFs (sAVF). This study has 2 primary objectives: First, to compare clinical outcomes of pAVFs to sAVFs, with emphasis on clinical maturation and frequency of postoperative interventions to facilitate maturation. Second, to contribute toward the evidence-based incorporation of the pAVF procedure into the hemodialysis access algorithm. METHODS: A single-center retrospective review was performed on all consecutive patients undergoing surgically created brachiocephalic arteriovenous fistula (BC-AVF, sAVF group) from January 1, 2018 to December 31, 2018 and Ellipsys-created percutaneous arteriovenous fistula (pAVF group) from January 1, 2019 to December 31, 2019. Comparative analysis between groups was performed. RESULTS: A total of 24 patients underwent Ellipsys-created pAVF with mean age of 56.7 ± 22.6 years (12 males [50%], 12 females [50%]) and 62 patients underwent surgically created BC-AVF with mean age of 62.5 ± 13.2 years (32 males [52%], 30 females [48%]). Both the pAVF and sAVF groups had comparable mean operating times (60 ± 40 vs. 56 ± 25 min, Pâ¯=â¯0.67) and frequency of procedural technical success (23 [96%] vs. 62 [100%], Pâ¯=â¯0.28), respectively. The pAVF group had a lower clinical maturation rate (12 [52%] vs. 54 [87%], Pâ¯=â¯0.003) and a higher primary failure rate (9 [39%] vs. 6 [10%], Pâ¯=â¯0.003) when compared to the sAVF group. The pAVF group had an increased overall rate of undergoing a postoperative intervention (18 [78%] vs. 13 [21%], P< 0.001), as well as an increased number of total postoperative interventions (1.1 ± 0.9 vs. 0.3 ± 0.6 interventions, P< 0.001) compared to the sAVF group. Percutaneous transluminal angioplasty of the juxta anastomotic segment was the most prevalent postoperative intervention performed in the pAVF group and occurred at a significantly increased frequency when compared to the sAVF group rate (13 [57%] vs. 5 [8%], P< 0.001). CONCLUSIONS: In our single-center retrospective review, patients undergoing Ellipsys-created pAVF in the first year following introduction of percutaneous endovascular had inferior rates of clinical maturation and underwent more postoperative interventions when compared to historical patients undergoing surgically created BC-AVF. Outcome discrepancies compared to previously reported Ellipsys data demonstrate a need for further studies examining the practical translatability of the pAVF.
Asunto(s)
Derivación Arteriovenosa Quirúrgica , Arteria Braquial/cirugía , Procedimientos Endovasculares , Diálisis Renal , Extremidad Superior/irrigación sanguínea , Adulto , Anciano , Derivación Arteriovenosa Quirúrgica/efectos adversos , Derivación Arteriovenosa Quirúrgica/instrumentación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , New Mexico , Tempo Operativo , Complicaciones Posoperatorias/etiología , Evaluación de Programas y Proyectos de Salud , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: The VasQTM device was designed to improve the outcome of arteriovenous fistulae by optimizing the hemodynamics of the flow in the juxta-anastomotic region of the arteriovenous fistulae through tailored external support. The aim of the study was to evaluate the impact of the VasQ on outcome of radiocephalic arteriovenous fistulae in a real-world setting. METHODS: This was a single-center, retrospective analysis of patients with either fistula creation before or after dialysis initiation with implantation of the VasQ device during creation of end-to-side radiocephalic arteriovenous fistulae between June 2018 and May 2019. The flow rate and vein diameter were evaluated intraoperatively, at discharge within 48 h postprocedure and at a follow-up of 1, 3, 6, 9, and 12 months. RESULTS: Thirty-three VasQ devices were implanted during 33 radiocephalic arteriovenous fistula procedures. The study population comprised mostly of men, with an average age of 66 years. Mean intraoperative flow was 428 mL/min (range: 130-945). All patients were discharged with patent arteriovenous fistulae and mean fistula flow of 740 mL/min (range: 230-1300 mL/min). The primary patency was 100% and 79% at 3 and 6 months, respectively. Cumulative/secondary patency was 100% and 90% at 3 and 6 months, respectively. CONCLUSION: Data presented here suggest that the VasQ device has the potential to provide benefit to the functionality of radiocephalic arteriovenous fistulae.
Asunto(s)
Derivación Arteriovenosa Quirúrgica/instrumentación , Arteria Radial/cirugía , Diálisis Renal , Extremidad Superior/irrigación sanguínea , Grado de Desobstrucción Vascular , Adulto , Anciano , Anciano de 80 o más Años , Derivación Arteriovenosa Quirúrgica/efectos adversos , Femenino , Alemania , Humanos , Masculino , Persona de Mediana Edad , Arteria Radial/diagnóstico por imagen , Arteria Radial/fisiopatología , Flujo Sanguíneo Regional , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: More than 400,000 Americans require dialysis, and many receive it via a prosthetic arteriovenous graft. Infection of these grafts is rare, but associated with significant morbidity and mortality. The gold standard is total graft excision with arteriotomy closure. This was previously done with autologous vein, but bovine tissue offers a reasonable alternative. The objective of this article is to evaluate a community hospital experience with bovine tissue arterial repair after total graft excision of infected prosthetic arteriovenous graft. METHODS: A retrospective review was performed of all cases of infected prosthetic arteriovenous graft removal with bovine tissue arterial repair was performed. Thirteen cases were identified. Presentation, location of graft, and causative organism were reviewed; outcomes including reoperation and mortality were recorded. RESULTS: Of the 13 patients, 12 (92%) had positive cultures of the graft, bloodstream, or wound. Methicillin-resistant Staphylococcus aureus was the most commonly isolated organism (54%). There were two unplanned reoperations including hematoma drainage and wound debridement within the first year. Over the 1-year follow-up period, 1 patient died for a mortality of 8%. There were no re-infections during follow-up. DISCUSSION: Prosthetic arteriovenous graft infection remains a difficult challenge and is associated with significant morbidity and mortality. It presents in a variety of ways, including within an old thrombosed graft. Over the last several years, the causative organism has increasingly become drug resistant. Treatment with total graft excision requires arteriotomy closure, and for this bovine tissue has been demonstrated to be a viable option.
Asunto(s)
Derivación Arteriovenosa Quirúrgica/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular/efectos adversos , Arterias Carótidas/trasplante , Remoción de Dispositivos , Pericardio/trasplante , Infecciones Relacionadas con Prótesis/cirugía , Diálisis Renal , Adulto , Anciano , Animales , Derivación Arteriovenosa Quirúrgica/instrumentación , Derivación Arteriovenosa Quirúrgica/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Bovinos , Bases de Datos Factuales , Remoción de Dispositivos/efectos adversos , Remoción de Dispositivos/mortalidad , Femenino , Xenoinjertos , Humanos , Masculino , Persona de Mediana Edad , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/microbiología , Infecciones Relacionadas con Prótesis/mortalidad , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Surgical resection could be an eradication treatment for patients with infected hemodialysis arteriovenous grafts (AVGs). This study aimed to investigate the outcomes of 3 surgical methods, including total resection, subtotal resection, and revision. METHODS: The patients who underwent surgical excision of infected AVGs performed at a single center from August 2012 to March 2019 were retrospectively analyzed. The following 3 surgical methods were used in our study: revision, subtotal resection, and total resection. Patients' demographics, medical history, perioperative details, reconstruction time, and follow-up data were collected. The outcomes including perioperative complications (within 30 days), mortality, reinfection rate of AVGs, with new access reconstruction or not, and the outcomes between reconstruction and nonreconstruction in the follow-up period were evaluated. RESULTS: Forty-one patients had infected AVGs in our study. Patients' mean age was 62 years, and 65.9% of the patients were female. The mean duration from the time of diagnosis to the operation was 14.4 days. Signs and symptoms at presentation included fever (51.2 %), swelling (43.9%), pain (58.5%), erythematous change (92.7%), and more severe features, such as altered consciousness (14.6%) and hypotension (12.2%). The pathological changes in the infected grafts included bleeding (29.3%), pus formation (73.2%), pseudoaneurysm (26.8%), and graft exposure (17.1%). Wound and graft cultures revealed an infectious etiology with fungi (7.3%), Pseudomonas aeruginosa (12.2%), Enterococcus spp. (2.4%), and Staphylococcus spp. (58.5%), with methicillin-resistant Staphylococcus aureus accounting for only 7.3%. Total resection, subtotal resection, and revision surgery were performed in 17.1%, 63.4%, and 19.5% of patients, respectively. Seven patients with complications required reoperation (17.1%), and adhesion ileus and hospital-acquired pneumonia occurred in only 2.4% and 7.3% of patients, respectively. During follow-up, most patients (82.9%) had reconstruction of the peripheral hemodialysis access with mean time of 64.3 (range: 21-92) days; mean time of use of new access was 90.5 days; and mean time of removal of catheter was about 106.3 days. Mortality rates in patients without and with reconstructed AV access during follow-up were 50% and 18%, respectively (P < 0.004). Eight cases (19.5%) had recurrence of AV access infections during follow-up; of these, 2 had revision surgery and 6 had subtotal resection. However, no patient with total resection had recurrent infections. CONCLUSIONS: The total resection group had no recurrent infection compared to the subtotal and revision groups. In addition, patients with reconstruction of peripheral hemodialysis access had a low mortality rate during the follow-up period.
Asunto(s)
Derivación Arteriovenosa Quirúrgica/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Prótesis Vascular/efectos adversos , Remoción de Dispositivos , Infecciones Relacionadas con Prótesis/cirugía , Diálisis Renal , Derivación Arteriovenosa Quirúrgica/instrumentación , Derivación Arteriovenosa Quirúrgica/mortalidad , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Remoción de Dispositivos/efectos adversos , Remoción de Dispositivos/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/terapia , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/microbiología , Infecciones Relacionadas con Prótesis/mortalidad , Recurrencia , Reoperación , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
We report a case of stenosis involving the midportion of a polytetrafluoroethylene graft caused by the infiltration of fibroblasts into the lumen of the graft with the development of fibrovascular tissue.
Asunto(s)
Derivación Arteriovenosa Quirúrgica/efectos adversos , Implantación de Prótesis Vascular/efectos adversos , Fibroblastos/patología , Oclusión de Injerto Vascular/etiología , Fallo Renal Crónico/terapia , Neointima , Diálisis Renal , Anciano , Derivación Arteriovenosa Quirúrgica/instrumentación , Prótesis Vascular , Implantación de Prótesis Vascular/instrumentación , Remoción de Dispositivos , Oclusión de Injerto Vascular/diagnóstico por imagen , Oclusión de Injerto Vascular/patología , Oclusión de Injerto Vascular/cirugía , Humanos , Hiperplasia , Masculino , Politetrafluoroetileno , Diseño de Prótesis , Resultado del TratamientoRESUMEN
BACKGROUND: The first arteriovenous fistulas were created at the wrist more than 60 years ago. Basic surgical construction techniques remain unchanged with mobilization and repositioning of the vessels followed by a sutured anastomosis. We used the Ellipsys device to construct percutaneous radiocephalic-arteriovenous fistulas at the wrist and report the results. METHODS: Data were reviewed retrospectively for all patients who had a percutaneous radiocephalic-arteriovenous fistula created during a 6-month period. Each individual underwent ultrasound vessel mapping in addition to physical examination. When a radiocephalic-arteriovenous fistula was feasible and a communicating vein ⩾ 2 mm in diameter was noted in the distal forearm along with a radial artery ⩾ 2 mm, a percutaneous radiocephalic-arteriovenous fistula was considered and reviewed with the patient. RESULTS: Four individuals met the criteria to consider a percutaneous radiocephalic-arteriovenous fistula and all elected to have the procedure performed. Ages were 54-85 years. Three were diabetic and one was female. All percutaneous radiocephalic-arteriovenous fistulas were technically successful. Two individuals had not yet started dialysis therapy. Successful and repetitive cannulation for the two individuals with catheters was initiated at 4 and 8 weeks post procedure. The two pre-dialysis patients had physiologic arteriovenous fistula maturation (6 mm vein diameter and >500 mL/min flow) at 4 and 12 weeks. There were no procedural or late complications and none required intervention. Follow-up was 8-23 months (mean 16 months). CONCLUSION: The success of these percutaneous radiocephalic-arteriovenous fistulas suggests that use of the Ellipsys device will be applicable at the wrist in selected patients where appropriate vessel sizes and configurations are found.
Asunto(s)
Derivación Arteriovenosa Quirúrgica , Implantación de Prótesis Vascular , Arteria Radial/cirugía , Diálisis Renal , Muñeca/irrigación sanguínea , Anciano , Anciano de 80 o más Años , Derivación Arteriovenosa Quirúrgica/efectos adversos , Derivación Arteriovenosa Quirúrgica/instrumentación , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Arteria Radial/diagnóstico por imagen , Arteria Radial/fisiopatología , Estudios Retrospectivos , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
OBJECTIVE: We evaluate the creation of a percutaneous proximal radial artery-radial vein arteriovenous fistula with Ellipsys® instead of the usual first-stage brachial artery fistula prior to a second-stage brachial vein elevation, in patients with inadequate cephalic and basilic veins. METHODS: Single center study of eight patients (six males, mean = 54 years) who underwent a two-stage brachial vein elevation procedure between May 2017 and October 2019. Inclusion criteria were life expectancy > 6 months, patent brachial and proximal radial artery (>2 mm in diameter) absent/inadequate cephalic and basilic veins, existence of a brachial vein >3 mm in diameter, and in continuity with a proximal radial vein > 2 mm in diameter. RESULTS: Technical success was 100%. Four patients required angioplasty of a juxta-anastomotic stenosis, accounting for a 6-month primary and secondary patency rates were 68% and 100%, respectively. Access flow averaged 982 mL/min (range 768-1586) at final follow-up evaluation. There were no significant adverse events related to the procedures. All fistulae were elevated at 4-12 (mean: 8) weeks post creation and were successfully cannulated with two needles after healing was completed (2-4 weeks after elevation). No patients developed hand ischemia or arm edema. CONCLUSIONS: Percutaneous creation of a proximal radial artery-radial vein fistula followed by brachial vein elevation is a safe and reliable option for autogenous access creation in patients with inadequate cephalic or basilic veins. Minimally invasive radial artery inflow and longer available length of the targeted brachial vein available for elevation are the main advantages in skilled hands.