Impact of arteriovenous fistulas versus arteriovenous grafts on vascular access performance in haemodialysis patients: A systematic review and meta-analysis

Vascular ◽  
2021 ◽  
pp. 170853812110414
Author(s):  
Shahin Hajibandeh ◽  
Hannah Burton ◽  
Philippa Gleed ◽  
Shahab Hajibandeh ◽  
Teun Wilmink
Keyword(s):  
Failure Rate ◽  
Vascular Access ◽  
Meta Analysis ◽  
Primary Patency ◽  
Free Access ◽  
Secondary Patency ◽  
Confounding By Indication ◽  
Arteriovenous Fistulas ◽  
Significant Difference ◽  
Arteriovenous Grafts

Background Controversy exists regarding the best-performing vascular access type for patients undergoing haemodialysis. We aimed to compare outcomes of starting dialysis on arteriovenous fistulas (AVFs) versus arteriovenous grafts (AVGs) in haemodialysis patients. Methods We conducted a systematic search of multiple electronic information sources and bibliographic reference lists. The following outcome parameters were evaluated at 1, 2 and 5 years: primary failure, defined as access never used for dialysis; primary patency, defined as intervention-free access survival; primary-assisted patency, defined as uninterrupted access survival with interventions; and secondary patency, defined as cumulative access survival. Results We identified 15 comparative studies reporting a total of 118,434 patients who initiated haemodialysis with AVF ( n = 95,143) or AVG ( n = 23,291). Our analysis demonstrated that AVF was associated with significantly higher primary failure rate (OR: 2.05, p = .0005) but significantly higher rate of primary patency at 1 year (OR: 1.91, p < .00001), at 2 years (OR: 2.52, p < .00001) and at 5 years (OR: 2.59, p < .00001); and primary-assisted patency at 1 year (OR: 1.71, p < .00001), at 2 years (OR: 2.13, p < .00001) and 5 years (OR: 2.79, p < .00001). There was no significant difference in secondary patency at 1 year (OR: 1.08, p < .00001) but AVF had better secondary patency at 2 years (OR: 1.26, p < .00001) and 5 years (OR: 1.60, p < .00001) than AVG. Conclusions The meta-analysis of best available comparative evidence (Level 2) demonstrated that AVFs may be associated with significantly higher primary failure rate but higher primary patency, primary-assisted patency and secondary patency at 1, 2 and 5 years compared to AVGs. However, the available evidence is subject to significant selection bias and confounding by indication.

Tapered and non-tapered prosthetic grafts in upper extremity dialysis access: A systematic review and meta-analysis

2020 ◽  
pp. 112972982097417
Author(s):  
Venkata Sai Jasty ◽  
David Haddad ◽  
Babu Mohan ◽  
Wei Zhou ◽  
Jeffrey J Siracuse ◽  
...  
Keyword(s):  
Systematic Review ◽  
Upper Extremity ◽  
Meta Analysis ◽  
Primary Patency ◽  
Secondary Patency ◽  
Dialysis Access ◽  
Significant Difference ◽  
Arteriovenous Grafts ◽  
Meta Analyses ◽  
Steal Syndrome

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.

Comparing Outcomes of Upper Extremity Brachiobasilic Arteriovenous Fistulas and Arteriovenous Grafts: A Systematic Review and Meta-Analysis

2020 ◽  
pp. 112972982097078
Author(s):  
David J. Haddad ◽  
Venkata Sai Jasty ◽  
Babu Mohan ◽  
Chiu-Hsieh Hsu ◽  
Chyi Chyi Chong ◽  
...  
Keyword(s):  
Systematic Review ◽  
Upper Extremity ◽  
Meta Analysis ◽  
Primary Patency ◽  
Secondary Patency ◽  
Random Effects Model ◽  
Hemodialysis Access ◽  
Basilic Vein ◽  
Arteriovenous Fistulas ◽  
Arteriovenous Grafts

Objective: It is unclear what the optimal upper extremity hemodialysis access is for patients without a suitable cephalic vein for arteriovenous fistulas (AVFs). The objective of this systematic review and meta-analysis was to compare the outcomes for upper extremity transposed brachiobasilic AVFs (BBAVFs) and prosthetic arteriovenous grafts (AVGs). Methods: A systematic review was performed to identify all English publications and abstracts comparing the patency outcomes of upper extremity BBAVFs and AVGs (January 1st, 1994 to April 1st, 2020). The outcomes assessed were 1-year and 2-year primary and secondary patency rates. Pooled odds ratios (OR) were calculated using the random-effects model, and I2 statistic was used to assess between-study variability. Results: Twenty-three studies examining 2799 patients were identified and included in the study. The 1-year primary patency rates (OR = 1.68, 95% CI 1.24–2.28, p = 0.001, I2 = 69.40%) and 2-year primary patency rates (OR = 2.33, 95% CI 1.59–3.43, p < 0.001, I2 = 68.26%) were significantly better for BBAVFs than AVGs. Compared to AVGs, the 1-year secondary patency rates (OR = 1.45, 95% CI 1.05–1.98, p = 0.022, I2 = 56.64%) and 2-year secondary patency rates (OR = 1.93, 95% CI 1.39–2.68, p < 0.001, I2 = 57.61%) were also significantly higher for BBAVFs. Conclusion: The outcomes for upper extremity BBAVFs appear to be consistently superior to prosthetic hemodialysis access. This analysis supports the preferential placement of BBAVFs over AVGs in patients with a suitable upper extremity basilic vein.

Thigh arteriovenous grafts. Quantitative comparison with alternative options: A meta-analysis

2018 ◽  
Vol 19 (5) ◽  
pp. 430-435 ◽  
Author(s):  
Miltos K Lazarides ◽  
Christos Argyriou ◽  
Andreas Koutsoumpelis ◽  
Efstratios I Georgakarakos ◽  
George S Georgiadis
Keyword(s):  
Confidence Interval ◽  
Failure Rate ◽  
Lower Limb ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Femoral Vein ◽  
Primary Patency ◽  
Secondary Patency ◽  
Number Of Patients ◽  
Arteriovenous Grafts

Thigh arteriovenous grafts are required in a number of patients with exhausted upper extremity veins and comprise 1%–5% of the total access procedures performed. Alternative autogenous lower extremity options are the rarely used sapheno-tibial arteriovenous fistulae, the saphenous vein transpositions, and the femoral vein transpositions. The latter have proven to be the most durable lower limb access procedures, with low infection rates and their primary patency rates ranged from 74% up to 87% at 2 years. Synthetic thigh grafts are suitable for patients who are not good candidates for any upper limb or any autogenous lower limb access and their secondary patency rates ranged from 54% up to 83% at 2 years. Thigh grafts often get infected and their average weighed infection rate in 920 such grafts included in eight large series was 22.9%. A literature search was performed to evaluate thigh grafts compared with alternative options using meta-analysis. Lower limb accesses were found superior compared to HeRO® device regarding 1-year primary failure rate (odds ratio = 0.28, confidence interval = 0.09–0.88, p = 0.03) and additionally autogenous lower limb accesses were found superior compared to thigh grafts regarding the 1-year primary failure rate (odds ratio = 6.54, confidence interval = 2.29–18.72, p = 0.0005).

The usefulness and feasibility of placing a clinch knot with a guidewire to achieve temporary hemostasis in arteriovenous dialysis access interventions

2020 ◽  
pp. 112972982095474
Author(s):  
Sung-Joon Park ◽  
Hwan Hoon Chung ◽  
Seung Hwa Lee ◽  
Sung Beom Cho ◽  
Tae-Seok Seo ◽  
...  
Keyword(s):  
Clinical Success ◽  
Primary Patency ◽  
Interventional Treatment ◽  
Secondary Patency ◽  
Dialysis Access ◽  
Hemodialysis Access ◽  
Purse String Suture ◽  
Purse String ◽  
Arteriovenous Fistulas ◽  
Arteriovenous Grafts

Purpose: To evaluate the usefulness and feasibility of using a reversible clinch knot with a guidewire in place rather than eliminating the access route during an arteriovenous hemodialysis access (AV access) intervention using the facing sheath technique. Material and methods: From July 2016 to June 2019, we retrospectively studied 78 sessions performed as interventional treatment for arteriovenous (AV) hemodialysis (HD) access using the “facing-sheath technique.” In all sessions, all antegrade sheaths were removed while a 0.035-inch guidewire remained in place with purse-string suture and the clinch knot. Seventy-two sessions were performed in patients with thrombosed AV accesses (69 arteriovenous grafts [AVGs] and three arteriovenous fistulas [AVFs]), and six sessions were carried out to treat non-thrombosed AV accesses (four AVGs and two AVFs). We evaluated whether proper hemostasis and successful reinsertion of the sheath over the wire into the clinch knot was achieved. Clinical success was defined as achieving prompt restoration of blood flow for AV access, and the postintervention primary and secondary patency were also evaluated. Result: In all 87 clinch knots created in 78 total sessions, proper hemostasis was achieved. All clinch knots that required reversal for additional procedures were successfully reopened (55 clinch knots in 50 sessions). The postintervention primary patency rates at 1, 3, and 6 months, and at 1 year were 77.8%, 68.9%, 55.6%, and 33.3%, respectively. The postintervention secondary patency rates at 1, 3, and 6 months, and also at 1 year were 93.3%, 91.1%, 86.7%, and 86.7%, respectively. Conclusion: Our AV access intervention which used a clinch knot with purse-string suture while the guidewire remained in place was both useful and feasible for maintaining temporary hemostasis.

Single-centre experience with endovascular rotational thrombectomy for single session salvage of thrombosed arteriovenous fistulas and grafts

2021 ◽  
pp. 112972982110609
Author(s):  
Cheryl Lim ◽  
Justin Kwan ◽  
Zhiwen Joseph Lo ◽  
Qiantai Hong ◽  
Li Zhang ◽  
...  
Keyword(s):  
Vascular Access ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Primary Patency ◽  
Secondary Patency ◽  
Complication Rates ◽  
Single Session ◽  
Arteriovenous Fistulas ◽  
Rotational Thrombectomy ◽  
Thrombectomy Device

Objectives: This paper documents our experience and outcomes of using a relatively new endovascular rotational thrombectomy device for salvage of thrombosed vascular access. Methodology: A retrospective study reviewing patients with thrombosed native AVF or AVG who underwent endovascular declotting using a rotational thrombectomy device between November 2018 and May 2020 at a tertiary university hospital in Southeast Asia. We evaluated demographics, procedural data, technical and procedural success, patency rates and complications. Results: A total of 40 patients underwent single session endovascular declotting of thrombosed vascular access. The mean follow-up period was 21.6 months (range 13.4–31 months). The technical success was 92.5% and clinical success was 80%. About 50% of patients had concomitant thrombolysis for pharmacomechanical thrombectomy. One patient had a myocardial infarction during the post-operative period. There were no other major complications within 30 days. The primary patency was 45.5% at 6 months and 22.7% at 12 months. Assisted primary patency was 68.1% at 6 months and 61.6% at 12 months, which was maintained up to 2 years. The secondary patency was 84.1% at 6 and 12 months. Conclusion: Our study shows that rotational thrombectomy device for single session thrombectomy of thrombosed arteriovenous fistulas and grafts is safe and effective. A high technical and clinical success rate was achieved, with low complication rates and specific advantages compared to other techniques, including reduced length of hospital stay. Our reported mid-term outcomes are reasonable with an assisted primary patency of 62% at 12 and 24 months. The use of newer techniques and novel dedicated thrombectomy devices show promise.

Long-term patency rate of the translocated autologous saphenous vein versus prosthetic material in vascular access surgery for haemodialysis and parenteral nutrition

2021 ◽  
pp. 112972982110131
Author(s):  
Wouter Driessen ◽  
Wilbert van der Meijden ◽  
Geert Wanten ◽  
Frank van Hoek
Keyword(s):  
Parenteral Nutrition ◽  
Vascular Access ◽  
Saphenous Vein ◽  
Patency Rate ◽  
Primary Patency ◽  
Prosthetic Material ◽  
Secondary Patency ◽  
Kaplan Meier ◽  
Significant Difference

Objective: To evaluate the long-term patency rate of the arteriovenous angioaccess (AVA) with interposition of either autologous or prosthetic material as a last option for vascular access in the upper extremity. Methods: This is a retrospective chart review study of all patients who received an AVA with autologous saphenous vein (SV Group, n = 38) or prosthetic material (PTFE Group, n = 25) as a conduit from the year 1996 to 2020 in the Radboud University Medical Center (Radboudumc). Data were retrospectively extracted from two prospectively updated local databases for vascular access, one for haemodialysis (HD) and one for parenteral nutrition (PN). When required, the medical records of each patient were used. Data were eventually collected anonymously and analysed in SPSS 25. Kaplan-Meier life-tables were used for the statistical analysis. Results: Primary patency at 12 and 48 months was 30% and 20% in the SV group and 45% and 14% in the PTFE group. No significant difference was shown in the median primary patency rate ( p = 0.715). Secondary patency at 12 and 48 months was 63% and 39% in the SV group and 55% and 19% in the PTFE group. This was considered a significant difference in median secondary patency in favour of the SV with 41.16 ± 17.67 months against 13.77 ± 10.22 months for PTFE ( p = 0.032). The incidence of infection was significantly lower in the SV group ( p = 0.0002). A Kaplan-Meier curve could not detect a significant difference in secondary patency between the access for haemodialysis and the access for parenteral nutrition. The secondary patency of the SV in parenteral nutrition access, was significantly higher when compared with PTFE ( p = 0.004). Conclusion: The SV can be preferred over PTFE when conduit material is needed for long-term vascular access for HD or PN treatment due to its higher secondary patency and lower infection risk.

Plain versus paclitaxel-coated balloon angioplasty in arteriovenous fistula and graft stenosis: An umbrella review

2021 ◽  
pp. 112972982110052
Author(s):  
Miltos K Lazarides ◽  
Eleni Christaina ◽  
George A Antoniou ◽  
Christos Argyriou ◽  
Gregory Trypsianis ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Original Data ◽  
Target Lesion ◽  
Primary Patency ◽  
Umbrella Review ◽  
Arteriovenous Fistulas ◽  
Graft Stenosis ◽  
Significant Difference ◽  
Meta Analyses

An umbrella review was performed to synthesize the evidence from systematic reviews/meta-analyses of clinical trials investigating the efficacy and safety of paclitaxel-coated balloons (PCB) vs. conventional balloon angioplasty in arteriovenous fistulas (AVFs) and grafts stenosis. Medline (via PubMed) and SCOPUS databases were searched up to July 15th 2020. All meta-analyses that enrolled randomized controlled trials (RCTs) comparing PCB with plain balloons in AVFs and grafts were included. Re-analysis of original data was performed assessing predictive intervals (PI). Quality of the included meta-analyses was assessed using AMSTAR score. Eight meta-analyses were included and four clinical outcomes [target lesion primary patency (TLPP), circuit primary patency, mortality, complication rate] derived from 14 RCTs, were analyzed. There were no significant differences in the TLPP in meta-analyses providing data purely from autologous AVFs. Significant benefits regarding TLPP and circuit primary patency at 3, 6, and 12-months in favor of PCB were reported in four meta-analyses mixing AVFs and grafts; however when PI were assessed, in all but one meta-analysis these included the null value, indicating no significant benefit. In only one meta-analysis significant difference of TLPP at 12-months in favor of PCB was noticed. (Odds Ratio 0.0009 PI: 0.28-0.85) No mortality difference was noticed in four meta-analyses providing data up to 24 months. In conclusion this overview revealed a modest benefit of using PCB angioplasty compared to plain angioplasty in AVFs and graft stenosis. No increased mortality was noticed in the PCB group.

scholarly journals Efficacy of SMART Stent Placement for Salvage Angioplasty in Hemodialysis Patients with Recurrent Vascular Access Stenosis

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Shingo Hatakeyama ◽  
Terumasa Toikawa ◽  
Akiko Okamoto ◽  
Hayato Yamamoto ◽  
Kengo Imanishi ◽  
...  
Keyword(s):  
Shape Memory Alloy ◽  
Vascular Access ◽  
Major Complication ◽  
Hemodialysis Patients ◽  
Primary Patency ◽  
Secondary Patency ◽  
Kaplan Meier ◽  
Short Period ◽  
Significant Difference ◽  
Vascular Access Stenosis

Vascular access stenosis is a major complication in hemodialysis patients. We prospectively observed 50 patients in whom 50 nitinol shape-memory alloy-recoverable technology (SMART) stents were used as salvage therapy for recurrent peripheral venous stenosis. Twenty-five stents each were deployed in native arteriovenous fistula (AVF) and synthetic arteriovenous polyurethane graft (AVG) cases. Vascular access patency rates were calculated by Kaplan-Meier analysis. The primary patency rates in AVFversusAVG at 3, 6, and 12 months were 80.3%versus75.6%, 64.9%versus28.3%, and 32.3%versus18.9%, respectively. The secondary patency rates in AVFversusAVG at 3, 6, and 12 months were 88.5%versus75.5%, 82.6%versus61.8%, and 74.4%versus61.8%, respectively. Although there were no statistically significant difference in patency between AVF and AVG, AVG showed poor tendency in primary and secondary patency. The usefulness of SMART stents was limited in a short period of time in hemodialysis patients with recurrent vascular access stenosis.

P1360ARTERIOVENOUS FISTULA MATURATION DELAY - ENDOVASCULAR TREATMENT IS A VALID APPROACH

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Rui Nogueira ◽  
Nuno Oliveira ◽  
Emanuel Ferreira ◽  
Ana Belmira ◽  
Rui Alves
Keyword(s):  
Endovascular Treatment ◽  
Arteriovenous Fistula ◽  
Treatment Option ◽  
Vascular Access ◽  
Primary Patency ◽  
Anastomotic Stenosis ◽  
Secondary Patency ◽  
Maturation Delay ◽  
Arteriovenous Fistulas ◽  
Delayed Maturation

Abstract Background and Aims Arteriovenous fistula is the optimal vascular access for hemodialysis as it has the best long-term patency rate and the lowest complication rate among hemodialysis vascular accesses. However, its occasional delayed maturation poses a challenge. Surgery has been advocated as the best treatment option. We proposed to evaluate the results of endovascular approach of arteriovenous fistula’s maturation delay in our hospital. Method We conducted a retrospective study, selecting patients referenced to our diagnostic and therapeutic angiography unit due to arteriovenous fistula delayed maturation, between April 2017 and October 2019. Physical examination and echography were used to confirm arteriovenous fistula delayed maturation. Results Thirty patients were referenced. Nine were excluded as maturation delay was not confirmed. Three patients were excluded due to extensive outflow stenosis since they were proposed to new vascular access creation. The other 18 patients were subjected to percutaneous endovascular treatment. Mean patient’s age was 65 years old. Twelve patients (66,7%) had forearm fistulas and the remaining (33,3%) had arm fistulas. Fourteen patients (77,7%) had maturation delay due to peri-anastomotic stenosis. The mean follow-up time was 14 months, (minimum - 3 months; maximum - 33 months). Seventeen fistulas (94,4%) were salvaged, although 3 (16,7%) needed a second intervention. Primary and secondary patencies at 3, 6 and 12 months were 77,8% vs. 94,4%, 69,2% vs. 92,3% and 75% vs. 100%, respectively. Arm fistulas had 83,3% of primary and secondary patencies. Forearm fistula’s primary and secondary patencies were 66,7% vs. 91,6%, 57,1% vs. 100% and 60% vs. 100%, at 3, 6 and 12 months, respectively. When maturation failure was due to peri-anastomotic stenosis, primary and secondary patencies were 71,4% vs. 92,9%, 66,7% vs. 100% and 66,7% vs. 100% at 3, 6 and 12 months, respectively. Conclusion Even though we are still lacking consensus about the best treatment option for fistula’s maturation delay, current guidelines suggest that, at least in delayed maturation due to peri-anastomotic stenosis, surgery may be the best treatment. Our results point out that endovascular treatment is a good treatment option for arteriovenous fistulas with maturation delay, mainly in the arm fistulas. Even though surgical treatment appears to have better primary patency, a step by step approach seems to be a valid approach, as our secondary patency shows.

scholarly journals Covered stents versus balloon angioplasty for failure of arteriovenous access: a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e044356
Author(s):  
Benjamin Ng ◽  
Magnus Fugger ◽  
Igho Jovwoke Onakpoya ◽  
Andrew Macdonald ◽  
Carl Heneghan
Keyword(s):  
Systematic Review ◽  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Primary Patency ◽  
Secondary Patency ◽  
Covered Stents ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Meta Analyses ◽  
Stage Renal Disease

IntroductionPatients with end-stage renal disease may require arteriovenous (AV) access in the form of arteriovenous fistulae (AVFs) or arteriovenous grafts (AVGs) for haemodialysis. AV access dysfunction requires intervention such as plain balloon angioplasty or covered stents to regain patency.AimTo systematically review and meta-analyse the patency outcomes of covered stents in failing haemodialysis AV access, compared with balloon angioplasty.MethodsThe review was first registered on the International Prospective Register of Systematic Reviews (CRD42018069955) before data collection. We searched six electronic databases to identify relevant randomised controlled trials (RCTs) up until August 2020, without language restriction. Two reviewers assessed the suitability and quality of studies for inclusion using the Consolidated Standards of Reporting Trials guidelines. We meta-analysed data using a random-effects model.ResultsWe included seven studies including 1147 patients in the systematic review, of which 867 had AVGs and 280 had AVFs. One study was an ongoing RCT. In the meta-analyses, we assessed patients with failing AVGs only. Overall risk of bias was moderate. Covered stents were associated with lower loss of patency versus angioplasty alone at 6, 12 and 24 months (OR 4.48, 95% CI 1.98 to 10.14, p<0.001; OR 4.07, 95% CI 1.74 to 9.54, p=0.001; OR 2.24, 95% CI 1.17 to 4.29, p=0.01, respectively). Covered stents afforded superior access circuit primary patency compared with angioplasty alone at 6 and 12 months (OR 1.91, 95% CI 1.31 to 2.80, p<0.001; OR 1.97, 95% CI 1.14 to 3.41, p=0.02, respectively). This was not significant at 24 months. There was no significant difference in loss of secondary patency between groups at 12 or 24 months (OR 0.74, 95% CI 0.45 to 1.23, p=0.25; OR 0.67, 95% CI 0.29 to 0.154, p=0.34, respectively).ConclusionOur results support use of covered stents over angioplasty alone, at 6, 12 and 24 months in failing AVGs. Further clinical trials are warranted.

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