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Journal of Vascular Surgery Feb 2021Vascular closure devices (VCDs) have become a mainstay in endovascular interventions in recent years. On-label use only allows for retrograde interventions originating... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vascular closure devices (VCDs) have become a mainstay in endovascular interventions in recent years. On-label use only allows for retrograde interventions originating at the common femoral artery (CFA). However, off-label use in antegrade and/or superficial femoral artery (SFA) access has become more common in the treatment of peripheral arterial disease. Despite this, there is a paucity of comparative literature assessing individual VCD safety profiles and relative complication risks of CFA vs SFA applications.
METHODS
MEDLINE and EMBASE systematic searches were performed from inception to October 2019 to identify studies assessing VCD use in antegrade CFA and SFA interventions. Abstract selection and data extraction were performed by two independent reviewers. Primary outcomes included bleeding-related complications, vessel occlusion or stenosis, embolization, pseudoaneurysm formation, or arteriovenous fistula formation.
RESULTS
Twenty-four unique studies with 4124 vascular closure events via six unique VCDs were included (Angioseal, Exoseal, Femoseal, Glubran 2, Mynx, Starclose; 3698 CFA, 426 SFA). Pooled occurrence of all complications across closure devices used in the CFA and SFA ranged from 0.9% (Mynx) to 7.4% (Starclose) and 0% (Perclose) to 10.1% (Starclose), respectively, depending on VCD type. Clinically meaningful differences were identified between devices with a trend toward significance (P = .08 CFA, P = .07 SFA). Individual devices demonstrated a range of bleeding complication rates from 0.4% (Mynx) to 7.2% (Femoseal) for the CFA site and from 0% (Perclose) to 6.4% (Starclose) for the SFA site (P = .01 and P = .03, respectively). Significant heterogeneity between studies precludes definitive characterization of the device as cause for variations in bleeding complication rates. Pooled complication rates did not differ between the CFA and SFA arms (4.6% vs 5.8%, P = .56). Bleeding complication rates also did not differ between the CFA and SFA arms (3.6% vs 3.6%, P = .98).
CONCLUSIONS
Clinically meaningful differences in overall pooled complications were identified between VCDs with a trend toward significance. Significant differences between VCDs exist with respect to bleeding risk. However, this must be interpreted with caution as these differences could be secondary to interstudy heterogeneity. Finally, no difference was identified between antegrade SFA and CFA VCD use with respect to overall complication and bleeding risks.
Topics: Catheterization, Peripheral; Endovascular Procedures; Femoral Artery; Hemorrhage; Hemostatic Techniques; Humans; Punctures; Risk Assessment; Risk Factors; Treatment Outcome; Vascular Closure Devices
PubMed: 32950629
DOI: 10.1016/j.jvs.2020.08.133 -
BMC Anesthesiology Aug 2020Arteriovenous fistulae (AVF) are the hemodialysis access modality of choice for patients with end-stage renal disease. However, they have a high early failure rate. Good... (Comparative Study)
Comparative Study Meta-Analysis
BACKGROUND
Arteriovenous fistulae (AVF) are the hemodialysis access modality of choice for patients with end-stage renal disease. However, they have a high early failure rate. Good vascular access is essential to manage long-term hemodialytic treatment, but some anesthesia techniques directly affect venous diameter as well as intra- and post-operative blood flow. The main purpose of this meta-analysis was to compare the results of regional and local anesthesia (RA and LA) for arteriovenous fistula creation in end-stage renal disease.
METHODS
We conducted a systematic review and meta-analysis to synthesize evidence from 7 randomized controlled trials (565 patients) and 1 observational study (408 patients) with the aim of evaluating the safety and efficacy of RA versus LA in surgical construction of AVF.
RESULTS
Pooled data showed that RA was associated with higher primary patency rates than LA (odds ratio [OR], 1.88; 95% confidence interval [CI]: 1.24-2.84; P = 0.003; I = 31%). Additionally, brachial artery diameter was significantly increased in the RA versus LA group (mean difference [MD], 0.83; 95% CI: 0.75-0.92; P < 0.001; I = 97%) and the need for intra- as well as post-operative pain killers was significantly less (RA, P = 0.0363; LA, P = 0.0318). Moreover, operation duration was significantly reduced using RA versus LA (MD, - 29.63; 95% CI: - 32.78 - -26.48; P < 0.001; I = 100%).
CONCLUSIONS
This meta-analysis suggests that RA is preferable to LA in patients with end-stage renal disease in guaranteeing AVF patency and increasing brachial artery diameter.
Topics: Anesthesia, Conduction; Anesthesia, Local; Arteriovenous Shunt, Surgical; Humans; Kidney Failure, Chronic; Randomized Controlled Trials as Topic; Retrospective Studies; Treatment Outcome
PubMed: 32867692
DOI: 10.1186/s12871-020-01136-1 -
Kidney International Reports Jul 2020The last decade has seen a steady increase worldwide in the prevalence of end-stage renal disease (ESRD). Hemodialysis is the major modality of renal replacement therapy...
INTRODUCTION
The last decade has seen a steady increase worldwide in the prevalence of end-stage renal disease (ESRD). Hemodialysis is the major modality of renal replacement therapy (RRT) in 70% to 90% of patients, who require well-functioning vascular access for this procedure. The recommended access for hemodialysis is an arteriovenous fistula or a vascular graft. However, recourse to central venous catheters remains essential for patients whose chronic renal disease is diagnosed at the end stage or in whom an arteriovenous fistula cannot be created or maintained. Tunneled dialysis catheter (TDC) exposure can induce venous stenosis and occlusions and can result in superior vena cava syndrome and/or vascular access loss. Exhaustion of conventional vascular accesses is 1 of the greatest challenges that nephrologists and patients have to face. Several unconventional salvage-therapy routes for TDC placement in patients with exhausted upper body venous access have been reported in the literature.
METHODS
We report 2 new cases of intra-atrial TDC placement for patients with exhausted vascular access and perform a meta-analysis of cases from the literature.
RESULTS
A total of 51 patients were included. The TDC was inserted by a cardiovascular surgeon in all cases. At the end of follow-up, 75% patients were alive. The median survival time was 25 months. Survival time of hemodialysis patients with intra-atrial TDC was lower than that observed with conventional TDC.
CONCLUSIONS
This unconventional technique is safe and functional for hemodialysis patients with exhausted venous access. Atrial vascular access for TDC placement is salvage therapy and is therefore potentially lifesaving.
PubMed: 32647757
DOI: 10.1016/j.ekir.2020.04.006 -
Journal of Vascular Surgery Dec 2020The comparison between paclitaxel-coated balloon (PCB) angioplasty and plain balloon angioplasty (PBA) for hemodialysis (HD) access stenosis or occlusion has not been... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The comparison between paclitaxel-coated balloon (PCB) angioplasty and plain balloon angioplasty (PBA) for hemodialysis (HD) access stenosis or occlusion has not been well investigated. The objectives of this systematic review and meta-analysis were to compare all-cause mortality, HD access primary patency, and circuit primary patency after endovascular maintenance procedures using PCB angioplasty vs PBA.
METHODS
MEDLINE, Embase, and Cochrane Databases were systematically searched to identify all the relevant studies on paclitaxel-coated devices for stenosis or thrombosis of HD access. A random effects model was applied to pool the effect measures. Dichotomous data were presented using an odds ratio (OR). Effect data were presented using pooled hazard ratio (HR) with 95% confidence interval (CI).
RESULTS
A total of 16 studies were included in this meta-analysis, 12 randomized controlled trials and 4 cohort studies involving 1086 patients who underwent endovascular treatment for HD access stenosis or occlusion. All-cause mortality rates at 6, 12, and 24 months after intervention were similar between the PCB and PBA groups (6 months: OR, 1.06 [95% CI, 0.38-2.96; P = .907; I = 19.2%]; 12 months: OR, 1.20 [95% CI, 0.66-2.16; P = .554; I = 0%]; 24 months: OR, 1.43 [95% CI, 0.83-2.45; P = .195; I = 0%]). There was a significant improvement of primary patency in the PCB group compared with the PBA group (HR, 0.47; 95% CI, 0.33-0.69; P < .001; I = 67.3%). This benefit was consistent with the analysis of randomized controlled trials, whereas cohort studies were excluded. Further subgroup analysis of target lesions demonstrated that primary patency was significantly higher in the PCB group than in the PBA group, not only for arteriovenous fistula (HR, 0.54; 95% CI, 0.30-0.98; P = .041; I = 76.8%) but also for central venous stenosis (HR, 0.39; 95% CI, 0.22-0.71; P = .002; I = 0%). The PCB group was associated with higher 6-month (OR, 0.40; 95% CI, 0.27-0.59; P < .001) and 24-month lesion primary patency (OR, 0.28; 95% CI, 0.11-0.72; P = .009) than PBA and was marginally associated with 12-month lesion primary patency (OR, 0.52; 95% CI, 0.26-1.03; P = .06). Circuit primary patency analysis showed a marginal trend toward better outcome in the PCB group (HR, 0.63; 95% CI, 0.40-1.00) but no statistical significance (P = .052).
CONCLUSIONS
This systematic review and meta-analysis demonstrated that PCB angioplasty is associated with significantly improved primary patency of arteriovenous fistula and central venous stenosis for HD access maintenance, with no evidence of increasing all-cause mortality based on short-term and midterm follow-up. Further large cohort study is needed to investigate long-term mortality.
Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Equipment Design; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Recurrence; Renal Dialysis; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency
PubMed: 32540324
DOI: 10.1016/j.jvs.2020.04.525 -
PloS One 2020[This corrects the article DOI: 10.1371/journal.pone.0231463.].
Correction: Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials.
[This corrects the article DOI: 10.1371/journal.pone.0231463.].
PubMed: 32442223
DOI: 10.1371/journal.pone.0233923 -
The Journal of Vascular Access Jan 2021The aim of the present study was to perform cost-effectiveness and budget impact analyses comparing endovascular arteriovenous fistula creation to surgical arteriovenous... (Comparative Study)
Comparative Study
OBJECTIVES
The aim of the present study was to perform cost-effectiveness and budget impact analyses comparing endovascular arteriovenous fistula creation to surgical arteriovenous fistula creation in hemodialysis patients from the National Healthcare Service (NHS) perspective in Italy.
METHODS
A systematic literature review has been conducted to retrieve complications' rates after arteriovenous fistula creation procedures. One study comparing endovascular arteriovenous fistula creation, performed with WavelinQ device, to the surgical approach through propensity score matching was preferred to single-arm investigations to execute the economic evaluations. This study was chosen to populate a Markov model to project, on a time horizon of 1 year, quality adjusted life years and costs associated with endovascular arteriovenous fistula (WavelinQ) and surgical arteriovenous fistula options for both cohorts of incident and prevalent hemodialysis patients.
RESULTS
For both incident and prevalent hemodialysis patients, endovascular arteriovenous fistula creation, performed with WavelinQ, was the dominant strategy over surgical arteriovenous fistula approach, showing less cost and better patients' quality of life. Compared to the current scenario, progressively increasing utilization rates of WavelinQ over surgical arteriovenous fistula creation in the next 5 years in incident hemodialysis patients are expected to save globally 30-36 million euros to the NHS.
CONCLUSION
Endovascular arteriovenous fistula creation performed with WavelinQ could be a cost-saving strategy in comparison with the surgical approach for patients in hemodialysis. Future studies comparing different devices for endovascular arteriovenous fistula creation versus the surgical option would be needed to confirm or reject the validity of this preliminary evaluation. In the meantime, decision-makers can use these results to take decisions on the diffusion of endovascular procedures in Italy.
Topics: Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis Implantation; Budgets; Clinical Decision-Making; Cost Savings; Cost-Benefit Analysis; Decision Support Techniques; Endovascular Procedures; Health Care Costs; Humans; Italy; Markov Chains; Models, Economic; National Health Programs; Renal Dialysis; Treatment Outcome
PubMed: 32425096
DOI: 10.1177/1129729820921021 -
Annals of Translational Medicine Mar 2020Proximal femoral fracture (PFF), such as intertrochanteric femoral fracture or femur neck fracture, and its management are crucial issues to surgeons. PFF has been...
BACKGROUND
Proximal femoral fracture (PFF), such as intertrochanteric femoral fracture or femur neck fracture, and its management are crucial issues to surgeons. PFF has been dramatically is becoming exponentially prevalent, and it is at high risk of complication and mortality because it is frequently associated with serious trauma and advanced age, especially in patients treated with anticoagulants or antiplatelet agents. Surgical management is essential for the treatment of PFF. Unfortunately, current surgical procedures have been related to accompanied by vascular complications, including laceration, hemorrhage, thrombosis, embolism, intimal flap tear and pseudoaneurysm. Furthermore, these vascular injuries following surgical management of PFF are potentially limb- and life-threatening. Of the complications after operation of PFF, femoral arteriovenous fistula (AVF) is rare, but remains a challenging problem because it is frequently associated with significantly high mortality and morbidity and is very difficult to treat.
METHODS
A systematic literature review was conducted using the PRISMA guidelines with no language restriction. We searched scientific publications via PubMed, Embase, Cochrane central register of controlled trial, Google Scholar, the KoreaMed and the Research Information Sharing Service database. The goal of this study was to report on the incidence, clinical presentation, diagnosis, treatment, associated complications, morbidity and mortality of femoral AVF caused by PFF and to draw special attention to its prevention and management.
RESULTS
A total of 7 case reports on femoral AVF associated with operation of PFF were identified, and one our case was added to the systematic analysis. Of the 8 cases, 4 were male and 4 were female under the age of 67.87±18.44; 6 (75.0%) survived without any events, 1 (12.5%) survived with a sequela of peroneal nerve impairment, and 1 (12.5%) died of multi-organ failure and hypovolemia.
CONCLUSIONS
The incidence of femoral AVF associated with PFF is extremely low, though it appears to increase with the rising frequency of PFF. With a very few exceptions, complications following internal fixation are potentially limb- and life-threatening. There is still no definite consensus on the standardized diagnostic or therapeutic modalities. Therefore, surgeons should keep in mind that this serious complication requires early diagnosis and prompt treatment, which should not be underestimated. Femoral AVF following operation of PFF should be meticulously managed, because untreated fistulae result in serious unexpected complications including renin-mediated hypertension, high-output heart failure and venous and/or arterial insufficiency. Surgical treatment is still the gold standard for such cases, but in limited cases endovascular procedures using embolization and closure device can be a good treatment option.
PubMed: 32355735
DOI: 10.21037/atm.2020.03.08 -
PloS One 2020Restenosis remains a significant problem in endovascular therapy for hemodialysis vascular access. Drug-coated balloon (DCB) angioplasty decreases restenosis in... (Meta-Analysis)
Meta-Analysis
Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
Restenosis remains a significant problem in endovascular therapy for hemodialysis vascular access. Drug-coated balloon (DCB) angioplasty decreases restenosis in peripheral and coronary artery diseases. The aim of this systematic review and meta-analysis is to assess the patency outcomes following DCB angioplasty, as compared to conventional balloon (CB) angioplasty for the stenosis of hemodialysis vascular access.
METHODS
A comprehensive search in the MEDLINE, EMBASE, and CENTRAL databases was conducted in order to identify eligible randomized controlled trials evaluating DCB angioplasty for hemodialysis vascular access dysfunction. The primary endpoint was the 6-month target lesion primary patency and the secondary endpoints were 12-month target lesion primary patency and procedure-related complications. Risk ratios (RR) were pooled and relevant subgroups were analyzed separately.
RESULTS
Eleven randomized controlled trials comprised of 487 patients treated with DCB angioplasty and 489 patients treated with CB angioplasty were included. There were no significant differences in the target lesion primary patency at 6 months [RR, 0.75; 95% confidence interval (CI), 0.56, 1.01; p = 0.06] and at 12 months (RR 0.89; 95% CI, 0.79, 1.00; p = 0.06). The absence of benefit for the DCB group remained, even in the arteriovenous fistula subgroup or the subgroup of studies excluding central vein stenosis. The risk of procedure-related complication did not differ between the two groups (RR 1.00; 95% CI 0.98, 1.02; p = 0.95).
CONCLUSION
DCB angioplasty did not demonstrate significant patency benefit for the treatment of hemodialysis vascular access dysfunction. Wide variations in patency outcomes across studies were noted. Further studies focusing on specific types of access or lesions are warranted to clarify the value of DCB for hemodialysis vascular access. (PROSPERO Number CRD42019119938).
Topics: Aged; Aged, 80 and over; Angioplasty, Balloon; Arteriovenous Fistula; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Randomized Controlled Trials as Topic; Renal Dialysis; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency
PubMed: 32287283
DOI: 10.1371/journal.pone.0231463 -
Journal of Neurointerventional Surgery Sep 2020Despite the recent increase in the number of publications on diagnostic cerebral angiograms using transradial access (TRA), there have been relatively few regarding TRA...
BACKGROUND
Despite the recent increase in the number of publications on diagnostic cerebral angiograms using transradial access (TRA), there have been relatively few regarding TRA for neurointerventional cases. Questions of feasibility and safety may still exist among physicians considering TRA for neurointerventional procedures.
METHODS
A systematic literature review was performed following PRISMA guidelines. Three online databases (MedLine via PubMed, Scopus and Embase) were searched for articles published between January 2000 and December 2019. Search terms included "Transradial access", "Radial Access", "Radial artery" AND "Neurointerventions". The reference lists of selected articles and pertinent available non-systematic analysis were reviewed for other potential citations. Primary outcomes measured were access site complications and crossover rates.
RESULTS
Twenty-one studies (n=1342 patients) were included in this review. Two of the studies were prospective while the remaining 19 were retrospective. Six studies (n=616 patients) included TRA carotid stenting only. The rest of the studies included treatment for cerebral aneurysms (n=423), mechanical thrombectomy (n=127), tumor embolization (n=22), and other indications (n=154) such as angioplasty and stenting for vertebrobasilar stenosis, balloon test occlusion, embolization of dural arteriovenous fistula and arteriovenous malformation, chemotherapeutic drug delivery, intra-arterial thrombolysis, and arterial access during a venous stenting procedure. Two (0.15%) major complications and 37 (2.75%) minor complications were reported. Sixty-four (4.77%) patients crossed over to transfemoral access for completion of the procedure. Seven (0.52%) patients crossed over due to access failure and 57 (4.24%) patients crossed over to TFA due to inability to cannulate the target vessel.
CONCLUSION
This systematic review demonstrates that TRA has a relatively low rate of access site complications and crossovers. With increasing familiarity, development of TRA-specific neuroendovascular devices, and the continued reports of its success in the literature, TRA is expected to become more widely used by neurointerventionalists.
Topics: Angioplasty; Catheterization; Catheterization, Peripheral; Cerebral Angiography; Embolization, Therapeutic; Female; Humans; Intracranial Aneurysm; Male; Neurosurgical Procedures; Prospective Studies; Radial Artery; Randomized Controlled Trials as Topic; Retrospective Studies; Stents
PubMed: 32152185
DOI: 10.1136/neurintsurg-2019-015764 -
Journal of Vascular Surgery Mar 2020Owing to the lack of comparative evidence between the endovascular technologies for arteriovenous fistula (AVF) stenosis treatments, we sought to summarize the reported... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Owing to the lack of comparative evidence between the endovascular technologies for arteriovenous fistula (AVF) stenosis treatments, we sought to summarize the reported data comparing the effectiveness of different endovascular approaches for the treatment of AVF stenoses at the juxta-anastomotic site.
METHODS
We performed a systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases were searched from inception to June 12, 2018 for observational and randomized studies that had examined the effectiveness of AVF stenosis treatment using plain percutaneous balloon angioplasty (PTA), cutting balloon angioplasty, drug-eluting balloon (DEB) angioplasty, high-pressure balloon angioplasty, and stenting. Bias was assessed using the Newcastle-Ottawa scale for observational studies and the Cochrane Collaboration tool for randomized studies. Article screening, full-text review, assessment of bias, and data collection were conducted in duplicate, with a third reviewer to reconcile any discrepancies. We conducted a qualitative synthesis of the available evidence and a quantitative meta-analysis for the primary assisted patency outcome. The meta-analysis was conducted using Review Manager, version 5.3, using random effects models, with the I statistic used to assess heterogeneity. Statistical significance was set at P < .05.
RESULTS
Our search yielded 3683 reports. Of these, three randomized trials and three observational studies were included. Three studies with 342 patients had described the effectiveness of high-pressure balloon angioplasty, conventional PTA, and stenting and had analyzed the data qualitatively. Three studies with 141 patients had investigated native AVF patency after DEB angioplasty and conventional PTA and were included in the meta-analysis. DEB angioplasty showed significantly greater primary assisted patency rates at 12 months after treatment compared with PTA (odds ratio, 3.66; 95% confidence interval, 1.32-10.14; I = 49%). No statistically significant differences were found in 6-month primary assisted patency among the treatment groups (odds ratio, 2.03; 95% confidence interval, 0.64-6.45; I = 50%). A total of 58 of 72 AVFs remained patent 6 months after DEB angioplasty compared with 45 of 69 at 6 months after PTA. At 12 months after treatment, 48 of 72 AVFs remained patent after DEB angioplasty compared with 23 of 69 AVFs after PTA.
CONCLUSIONS
Our findings suggest DEB angioplasty is a more effective treatment option for AVF stenosis at the juxta-anastomotic site compared with PTA. Although DEB angioplasty might provide longer term patency than other endovascular treatments, further high-quality data are needed to confirm this finding.
Topics: Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Constriction, Pathologic; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Vascular Patency
PubMed: 32089200
DOI: 10.1016/j.jvs.2019.07.075