A Systematic Review of Registered Clinical Trials for Peripheral Nerve Injuries.

ABSTRACT: Upper extremity peripheral nerve injuries (PNIs) significantly impact daily functionality and necessitate effective treatment strategies. Clinical trials play a crucial role in developing these strategies. However, challenges like retrospective data collection, reporting biases, inconsistent outcome measures, and inadequate data sharing practices hinder effective research and treatment advancements. This review aims to analyze the landscape of reporting, methodological design, outcome measures, and data sharing practices in registered clinical trials concerning upper extremity PNIs. It seeks to guide future research in this vital area by identifying current trends and gaps.A systematic search was conducted on ClinicalTrials.gov and WHO International Clinical Trials Registry Platform up to November 10, 2023, using a combination of MeSH terms and keywords related to upper extremity nerve injury. The PRISMA 2020 guidelines were followed, and the studies were selected based on predefined inclusion and exclusion criteria. A narrative synthesis of findings was performed, with statistical analysis for associations and completion rates.Of 3051 identified studies, 96 met the inclusion criteria. These included 47 randomized controlled trials, 27 nonrandomized trials, and others. Sensory objective measures were the most common primary outcomes. Only 13 studies had a data sharing plan. The analysis revealed varied intervention methods and inconsistencies in outcome measures. There was a significant association between study funding, design, and completion status, but no association between enrollment numbers and completion.This review highlights the need for standardized outcome measures, patient-centered assessments, and improved data sharing in upper extremity PNI trials. The varied nature of interventions and inconsistency in outcome measures indicate the necessity for more rigorous and transparent research practices to strengthen the evidence base for managing these injuries.

Locoregional therapy containing surgery in metastatic breast cancer: Systematic review and meta-analysis.

INTRODUCTION: The role of locoregional therapy (LRT) containing surgery and systematic therapy in metastatic breast cancer patients remains controversial. This study investigated the effect of LRT in patients who were initially diagnosed with metastatic breast cancer (MBC) on overall survival (OS), locoregional progression-free survival (PFS), and distant systemic PFS. METHODS: The related keywords were searched in MEDLINE/PubMed, SCOPUS, and Web of Science databases up to August 15th, 2022. Hazard ratios (HR) with 95% confidence intervals (CIs) were pooled by the random-effects model. RESULTS: Seven articles with 1626 participants compared LRT with only systemic therapy (ST) for patients with de novo MBC. LRT did not improve (p = 0.28) OS compared to ST (HR: 0.83, 95% CI: 0.60, 1.16). LRT significantly improved locoregional PFS outcomes compared to ST (HR: 0.31, 95% CI: 0.15, 0.60, p = 0.001). LRT significantly (p = 0.001) improved OS in patients with solitary bone metastases (HR: 0.48; 95% CI: 0.35-0.67). CONCLUSION: LRT improves locoregional PFS. Furthermore, LRT improves OS in patients with solitary bone metastases.

The effect of anamorelin (ONO-7643) on cachexia in cancer patients: Systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Cachexia is associated with increased morbidity and mortality rates in patients with cancer. This meta-analysis aims to explore the effect of anamorelin on cancer cachexia markers. METHODS: We searched MEDLINE/PubMed, SCOPUS, and WOS from their inception until 5 June 2022. A systematic search was conducted according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines. We included trials investigating the effect of anamorelin on body weight, lean body mass, fat mass, insulin-like growth factor 1 (IGF-1), handgrip, quality of life insulin-like growth factor-binding protein 3 (IGFBP-3), and in patients with cancer. A random-effects model was run to pooled results. RESULTS: Five articles providing 1331 participants were analyzed in this study. Pooled analysis revealed a significant increase in body weight (weighted mean difference (WMD): 1.56 kg, 95% confidence interval (CI): 1.20, 1.92; I2= 0%), lean body mass (WMD: 1.36 kg, 95% CI: 0.85, 1.86; I2= 53.1%), fat mass (WMD: 1.02 kg, 95% CI: 0.51, 1.53; I2= 60.7%), IGF-1 (WMD: 51.16 ng/mL, 95% CI: 41.42, 60.90, I2= 0%), and IGFBP-3 (WMD: 0.43 µg/mL, 95% CI: 0.17, 0.68, I2= 98.6%). Results showed no significant increase in appetite when analysis run on all studies without considering different doses 0.29 (95% CI: -0.30, 0.89, I2= 73.8%), however, there was a significant increase in appetite without heterogeneity and inconsistency 0.59 (95% CI: 0.32, 0.86; I2= 0%) in the 100 mg/day group compared to anamorelin non-user. CONCLUSIONS: Patients with cancer who receive anamorelin as a treatment for cachexia showed a significant increase in body weight, lean body mass, fat mass, IGF-1, and IGFBP-3.

Perioperative systemic nonsteroidal anti-inflammatory drugs (NSAIDs) in women undergoing breast surgery.

BACKGROUND: Breast surgery encompasses oncologic, reconstructive, and cosmetic procedures. With the recent focus on the over-prescribing of opioids in the literature, it is important to assess the effectiveness and safety of non-opioid pain medication regimens including nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID pain medications. Clinicians have differing opinions on the safety of perioperative (relating to, occurring in, or being the period around the time of a surgical operation) NSAIDs for breast surgery given the unclear risk/benefit ratio. NSAIDs have been shown to decrease inflammation, pain, and fever, while potentially increasing the risks of bleeding complications. OBJECTIVES: To assess the effects of perioperative NSAID use versus non-NSAID analgesics (other pain medications) in women undergoing any form of breast surgery. SEARCH METHODS: The Cochrane Breast Information Specialist searched the Cochrane Breast Cancer Group (CBCG) Specialized Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, The WHO International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov registries to 21 September 2020. Full articles were retrieved for potentially eligible trials. SELECTION CRITERIA: We considered all randomized controlled trials (RCTs) looking at perioperative NSAID use in women undergoing breast surgery. DATA COLLECTION AND ANALYSIS: Two review authors independently screened studies, extracted data and assessed risk of bias, and certainty of the evidence using the GRADE approach. The main outcomes were incidence of breast hematoma within 90 days (requiring reoperation, interventional drainage, or no treatment) of breast surgery and pain intensity 24 hours following surgery, incidence rate or severity of postoperative nausea, vomiting or both, bleeding from any location within 90 days, need for blood transfusion, other side effects of NSAID use, opioid use within 24 hours of surgery, length of hospital stay, breast cancer recurrence, and non-prescribed NSAID use. Data were presented as risk ratios (RRs) for dichotomous outcomes and standardized mean differences (SMDs) for continuous outcomes. MAIN RESULTS: We included 12 RCTs with a total of 1596 participants. Seven studies compared NSAIDs (ketorolac, diclofenac, flurbiprofen, parecoxib and celecoxib) to placebo. Four studies compared NSAIDs (ketorolac, flurbiprofen, ibuprofen, and celecoxib) to other analgesics (morphine, hydrocodone, hydromorphone, fentanyl). One study compared NSAIDs (diclofenac) to no intervention. NSAIDs compared to placebo Most outcomes are judged to have low-certainty evidence unless stated otherwise. There may be little to no difference in the incidence of breast hematomas within 90 days of breast surgery (RR 0.33, 95% confidence interval (CI) 0.05 to 2.02; 2 studies, 230 participants; I2 = 0%). NSAIDs may reduce pain intensity 24 (± 12) hours following surgery compared to placebo (SMD -0.26, 95% CI -0.49 to -0.03; 3 studies, 310 participants; I2 = 73%). There may be little to no difference in the incidence rates or severities of postoperative nausea, vomiting, or both (RR 1.15, 95% CI 0.58 to 2.27; 4 studies, 939 participants; I2 = 81%), bleeding from any location within 90 days (RR 1.05, 95% CI 0.89 to 1.24; 2 studies, 251 participants; I2 = 8%), or need for blood transfusion compared to placebo groups, but we are very uncertain (RR 4.62, 95% CI 0.23 to 91.34; 1 study, 48 participants; very low-certainty evidence). There may be no difference in other side effects (RR 1.12, 95% CI 0.44 to 2.86; 2 studies, 251 participants; I2 = 0%). NSAIDs may reduce opioid use within 24 hours of surgery compared to placebo (SMD -0.45, 95% CI -0.85 to -0.05; 4 studies, 304 participants; I2 = 63%). NSAIDs compared to other analgesics There is little to no difference in the incidence of breast hematomas within 90 days of breast surgery, but we are very uncertain (RR 0.33, 95% CI 0.01 to 7.99; 1 study, 100 participants; very low-certainty evidence). NSAIDs may reduce pain intensity 24 (± 12) hours following surgery (SMD -0.68, 95% CI -0.97 to -0.39; 3 studies, 200 participants; I2 = 89%; low-certainty evidence) and probably reduce the incidence rates or severities of postoperative nausea, vomiting, or both compared to other analgesics (RR 0.18, 95% CI 0.06 to 0.57; 3 studies, 128 participants; I2 = 0%; moderate-certainty evidence). There is little to no difference in the development of bleeding from any location within 90 days of breast surgery or in other side effects, but we are very uncertain (bleeding: RR 0.33, 95% CI 0.01 to 7.99; 1 study, 100 participants; other side effects: RR 0.11, 95% CI 0.01 to 1.80; 1 study, 48 participants; very low-certainty evidence). NSAIDs may reduce opioid use within 24 hours of surgery compared to other analgesics (SMD -6.87, 95% CI -10.93 to -2.81; 3 studies, 178 participants; I2 = 96%; low-certainty evidence). NSAIDs compared to no intervention There is little to no difference in pain intensity 24 (± 12) hours following surgery compared to no intervention, but we are very uncertain (SMD -0.54, 95% CI -1.09 to 0.00; 1 study, 60 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: Low-certainty evidence suggests that NSAIDs may reduce postoperative pain, nausea and vomiting, and postoperative opioid use. However, there was very little evidence to indicate whether NSAIDs affect the rate of breast hematoma or bleeding from any location within 90 days of breast surgery, the need for blood transfusion and incidence of other side effects compared to placebo or other analgesics. High-quality large-scale RCTs are required before definitive conclusions can be made.

Hybrid repair versus conventional open repair for aortic arch dissection.

BACKGROUND: A dissection of the aorta is a separation or tear of the intima from the media. This tear allows blood to flow not only through the original aortic flow channel (known as the true lumen), but also through a second channel between the intima and media (known as the false lumen). Aortic dissection is a life-threatening condition which can be rapidly fatal. There is debate on the optimal surgical approach for aortic arch dissection. People with ascending aortic dissection have poor rates of survival. Currently open surgical repair is regarded as the standard treatment for aortic arch dissection. We intend to review the role of hybrid and open repair in aortic arch dissection. OBJECTIVES: To assess the effectiveness and safety of a hybrid technique of treatment over conventional open repair in the management of aortic arch dissection. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 8 February 2021. We also undertook reference checking for additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and clinical controlled trials (CCTs), which compared the effects of hybrid repair techniques versus open surgical repair of aortic arch dissection. Outcomes of interest were dissection-related mortality and all-cause mortality, neurological deficit, cardiac injury, respiratory compromise, renal ischaemia, false lumen thrombosis (defined by partial or complete thrombosis) and mesenteric ischaemia. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all records identified by the literature searches to identify those that met our inclusion criteria. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of the evidence using GRADE. MAIN RESULTS: We identified one ongoing study and two unpublished studies that met the inclusion criteria for the review. Due to a lack of study data, we could not compare the outcomes of hybrid repair to conventional open repair for aortic arch dissection. AUTHORS' CONCLUSIONS: This review revealed one ongoing RCT and two unpublished RCTs evaluating hybrid versus conventional open repair for aortic arch surgery. Observational data suggest that hybrid repair for aortic arch dissection could potentially be favourable, but conclusions can not be drawn from these studies, which are highly selective, and are based on the clinical status of the patient, the presence of comorbidities and the skills of the operators. However, a conclusion about its definitive benefit over conventional open surgical repair cannot be made from this review without published RCTs or CCTs. Future RCTs or CCTs need to have adequate sample sizes and follow-up, and assess clinically-relevant outcomes, in order to determine the optimal treatment for people with aortic arch dissection. It must be noted that this may not be feasible, due to the reasons mentioned.

Hybrid repair versus conventional open repair for thoracic aortic arch aneurysms.

BACKGROUND: Thoracic aortic arch aneurysms (TAAs) can be a life-threatening condition due to the potential risk of rupture. Treatment is recommended when the risk of rupture is greater than the risk of surgical complications. Depending on the cause, size and growth rate of the TAA, treatment may vary from close observation to emergency surgery. Aneurysms of the thoracic aorta can be managed by a number of surgical techniques. Open surgical repair (OSR) of aneurysms involves either partial or total replacement of the aorta, which is dependent on the extent of the diseased segment of the aorta. During OSR, the aneurysm is replaced with a synthetic graft. Hybrid repair (HR) involves a combination of open surgery with endovascular aortic stent graft placement. Hybrid repair requires varying degrees of invasiveness, depending on the number of supra-aortic branches that require debranching. The hybrid technique that combines supra-aortic vascular debranching with stent grafting of the aortic arch has been introduced as a therapeutic alternative. However, the short- and long-term outcomes of HR remain unclear, due to technical difficulties and complications as a result of the angulation of the aortic arch as well as handling of the arch during surgery. OBJECTIVES: To assess the effectiveness and safety of HR versus conventional OSR for the treatment of TAAs. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 22 March 2021. We also searched references of relevant articles retrieved from the electronic search for additional citations. SELECTION CRITERIA: We considered for inclusion in the review all published and unpublished randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing HR to OSR for TAAs. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all titles and abstracts obtained from the literature search to identify those that met the inclusion criteria. We retrieved the full text of studies deemed as potentially relevant by at least one review author. The same review authors screened the full-text articles independently for inclusion or exclusion. MAIN RESULTS: No RCTs or CCTs met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: Due to the lack of RCTs or CCTs, we were unable to determine the safety and effectiveness of HR compared to OSR in people with TAAs, and we are unable to provide high-certainty evidence on the optimal surgical intervention for this cohort of patients. High-quality RCTs or CCTs are necessary, addressing the objective of this review.

Acute surgical vs non-surgical management for ocular and peri-ocular burns: a systematic review and meta-analysis.

BACKGROUND: Burn-related injury to the face involving the structures of the eyes, eyelids, eyelashes, and/or eyebrows could result in multiple reconstructive procedures to improve functional and cosmetic outcomes, and correct complications following poor acute phase management. The objective of this article was to evaluate if non-surgical or surgical interventions are best for acute management of ocular and/or peri-ocular burns. METHODS: This systematic review and meta-analysis compared 272 surgical to 535 non-surgical interventions within 1 month of patients suffering burn-related injuries to 465 eyes, 253 eyelids, 90 eyelashes, and 0 eyebrows and evaluated associated outcomes and complications. The PubMed, Embase, Cochrane Library, Web of Science, and Scopus databases were systematically and independently searched. Patient and clinical characteristics, surgical and medical interventions, outcomes, and complications were recorded. RESULTS: Eight of the 14,927 studies queried for this study were eligible for the systematic review and meta-analysis, with results from 33 of the possible 58 outcomes and complications using Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) and Cochrane guidelines. Surgery was associated with standard mean differences (SMD) 0.44 greater visual acuity on follow-up, SMD 1.63 mm shorter epithelial defect diameters on follow-up, SMD 1.55 mm greater changes in epithelial diameters from baseline, SMD 1.17 mm2 smaller epithelial defect areas on follow-up, SMD 1.37 mm2 greater changes in epithelial defect areas from baseline, risk ratios (RR) 1.22 greater numbers of healed epithelial defects, RR 11.17 more keratitis infections, and a 2.2 greater reduction in limbal ischemia compared to no surgical intervention. CONCLUSIONS: This systematic review and meta-analysis found that compared to non-surgical interventions, acute surgical interventions for ocular, eyelid, and/or eyelash burns were found to have greater visual acuity on follow-up, shorter epithelial defect diameters on follow-up, greater changes in epithelial diameters from baseline, smaller epithelial defect areas on follow-up, greater changes in epithelial defect areas from baseline, greater numbers of healed epithelial defects, more keratitis infections, and a greater reduction in limbal ischemia, possibility preventing the need of a future limbal stem cell transplantation.

Kinetic Elephant Trunk Technique: Early Results in Chronic Symptomatic Aortic Dissection Management.

BACKGROUND: The aim was to expand our understanding of the dynamic evolution of the aorta throughout the dissection time course. We investigated how the disease process can be modulated to equalize lumen pressure, enhance perfusion, and stabilize the aorta along its entire length using the kinetic elephant trunk (kET) technique. METHODS: We performed the kET on 9 patients with chronic symptomatic aortic dissection (CSAD) as a primary or secondary intervention, regardless of the chronicity of the dissection. Endovascular scissoring of the intraluminal septum is performed in the infradiaphragmatic dissected aorta to equalize pressure between true and false lumens and allow all branched vessels to be supplied from one lumen. The Streamliner Multilayer Flow Modulator (SMFM), an uncovered cobalt-alloy aortic device, is deployed from the aortic sinus, covering the supra-aortic branches, distally into the distal aorta (primary intervention). In the case of a previous ascending aorta Dacron graft, the SMFM is deployed (secondary intervention) at the level of the Dacron graft so that it is overlapped with the graft and landed in the distal aorta. RESULTS: In the initial study period, all-cause and aortic-related survival were 100%, respectively; all great vessels and visceral branches were patent; and freedom of stroke, end-organ ischemia, paraplegia, and renal failure were 100%. CONCLUSIONS: The kET is a treatment process for managing CSAD. Its simplicity, consistency, and reproducibility in high-risk patients with low morbidity and mortality add to the armamentarium of the cardiovascular specialist. Further assessment of the medium- and long-term outcomes is needed to fully establish the benefits of kET.

Endovascular management of chronic symptomatic aortic dissection with the Streamliner Multilayer Flow Modulator: Twelve-month outcomes from the global registry.

OBJECTIVE: Reported are initial 12-month outcomes of patients with chronic symptomatic aortic dissection managed by the Streamliner Multilayer Flow Modulator (SMFM; Cardiatis, Isnes, Belgium). Primary end points were freedom from rupture- and aortic-related death, and reduction in false lumen index. Secondary end points were patency of great vessels and visceral branches, and freedom of stroke, paraplegia, and renal failure. METHODS: Out of 876 SMFM implanted globally, we have knowledge of 542. To date, 312 patients are maintained in the global registry, of which 38 patients were identified as having an aortic dissection (12.2%). Indications included 35 Stanford type B dissections, two Stanford type A and B dissections, and one mycotic Stanford type B dissection. RESULTS: There were no reported ruptures or aortic-related deaths. All cause survival was 85.3% Twelve-month freedom from neurologic events was 100%, and there were no incidences of end-organ ischemia, paraplegia or renal insult. Morphologic analysis exhibited dissection remodeling by a reduction in longitudinal length of the dissected aorta, and false lumen volume. A statistically significant reduction in false lumen index (P = .016) at 12 months, and a borderline significant increase in true lumen volume (P = .053) confirmed dissection remodeling. CONCLUSIONS: The SMFM is an option in management of complex pan-aortic dissection. Results highlight SMFM implantation leads to dissection stabilization with no further aneurysm progression, and no retrograde type A dissection. Thoracic endovascular aneurysm repair by SMFM ensued in freedom from aortic rupture, neurologic stroke, paraplegia and renal failure. Further analysis of the global registry data will inform long-term outcomes.

Computational fluid analysis of symptomatic chronic type B aortic dissections managed with the Streamliner Multilayer Flow Modulator.

OBJECTIVE: Managing symptomatic chronic type B aortic dissection (SCTBAD) by the Streamliner Multilayer Flow Modulator (SMFM) stent (Cardiatis, Isnes, Belgium) is akin to provisional structural support to induce complete attachment of the dissection flap, but with the ability of aortic remolding. This study investigated the SMFM's capability to enact healing of SCTBAD. METHODS: Clinical data for 12 cases comprising preoperative and postoperative treatment of SCTBAD were obtained from a multicenter database hosted by the Multilayer Flow Modulator Global Registry, Ireland. A biomechanical analysis, by means of computational fluid dynamics modeling, of the hemodynamic effects and branch patency associated with the use of the SMFM was performed for all cases. The mean length of the dissections was 30.23 ± 13.3 cm. There were 30 SMFMs used, which covered 69 aortic branches. RESULTS: At 1-year follow-up, the true lumen volume increased from 175.74 ± 98.83 cm3 to 209.87 ± 128.79 cm3; the false lumen decreased from 135.2 ± 92.03 cm3 to 123.19 ± 110.11 cm3. The false lumen index decreased from 0.29 ± 0.13 (preoperatively) to 0.21 ± 0.15 (postoperatively). The primary SMFM treatment of SCTBAD increased carotid perfusion by 35% ± 21% (P = .0216) and suprarenal perfusion by 78% ± 32% (P = .001). The wall pressure distribution blended along the newly enlarged true lumen, whereas the false lumen wall pressure decreased by 6.23% ± 4.81% for the primary group (cases 1-7) and by 3.84% ± 2.59% for the secondary group (cases 8-12). CONCLUSIONS: SMFM reduces the false lumen wall pressure through flow modulation. It preserves patency of all branches, minimizing the incidence of short-term complications. The SMFM is a valuable option in managing primary SCTBAD, without midterm complications.

Insights from complex aortic surgery with a Streamliner device for aortic arch repair (STAR).

OBJECTIVE: Aortic arch aneurysms and thoracoabdominal aortic arch aneurysms are technically challenging to manage by established surgical and endovascular methods. The Streamliner Multilayer Flow Modulator device (Cardiatis, Isnes, Brussels, Belgium) offers an unorthodox option for these high-risk cases. The Streamliner device for aortic arch repair (STAR) study investigated complex aneurysm cases managed by the Streamliner Multilayer Flow Modulator device and offers an analytic solution for a clinical dilemma. METHODS: Six cases were included, with a 1-year follow-up, comprising 4 pure arch aneurysms and 2 thoracoabdominal aortic arch aneurysms Crawford type I, from a multicenter database hosted by the Streamliner Multilayer Flow Modulator Global Registry. A total of 50% of cases were performed under instructions for use. All were American Society of Anesthesiology IV and originated from zone 0. All cases were computationally analyzed, which consisted of (1) simulating the treatment on the basis of the postoperative data, (2) repositioning the stents for the failed technical cases, and (3) assessing the effects of overlapping devices on branch patency. RESULTS: Correct device placement induced aneurysm flow streamlining, which reduced the dynamic pressure by 23% to 66%, whereas incorrect placements promoted Failure Mode I with 58% and 16% dynamic pressure increases and aneurysm volume expansion up to 23%. Overlapped devices improved distal perfusion by increasing arch branch outflows from 5% to 24%. The Streamliner Multilayer Flow Modulator device does not benefit a sac volume greater than 400 cm3. CONCLUSIONS: The Streamliner Multilayer Flow Modulator device is a new technology that can manage complex aortic arch aneurysms and thoracoabdominal aortic arch aneurysms with favorable clinical outcomes if it is performed under instructions for use. Careful procedure planning and perioperative virtual stent placement will avoid foreshortening, prevent inadequate stent overlap lengths, and provide insight into the sufficient numbers of required implanted devices.

Endovascular management of renal artery aneurysms using the multilayer flow modulator.

OBJECTIVE: Our aim was to describe our experience of the Multilayer Flow Modulator (MFM, Cardiatis, Isnes, Belgium) used in the treatment of type III renal artery aneurysms (RAA). METHODS: This is a single-centre study. 3 patients (2 men and 1 woman; mean age 59 years; range 41-77 years) underwent treatment of a type III renal artery aneurysm using the MFM. The indications were a 23.9 mm type III RAA at the bifurcation of the upper and lower pole vessels, with 4 side branches; a 42.4 mm type III saccular RAA at the renal hilum; and a 23 mm type III RAA at the origin of the artery, supplying the upper pole. RESULTS: Patients had a mean follow-up of 27 months, and were assessed by perioperative renal function tests, and repeat postoperative CT scan. There were no immediate postoperative complications or mortality. The first patient's aneurysm shrank by 8.6 mm, from 23.9 to 15.3 mm over 19 months, with all 4 side branches remaining patent. The largest aneurysm at 42.4 mm completely thrombosed, while the renal artery remained patent to the kidney. The final patient refused to have any follow-up scans but had no deterioration in renal function below 30 mL/min, and no further symptoms reported. CONCLUSIONS: The MFM is safe and effective in the management of patients with complex renal artery aneurysms. The MFM can be used to treat branched or distal renal artery aneurysms with exclusion of the aneurysm from the circulation, while successfully preserving the flow to the side branches and kidney. Initial results are promising, however, longer follow-up and a larger cohort are required to prove the effectiveness of this emerging technology.

Systematic Review and Patient-Level Meta-analysis of the Streamliner Multilayer Flow Modulator in the Management of Complex Thoracoabdominal Aortic Pathology.

PURPOSE: To examine the safety and short-term efficacy of the Streamliner Multilayer Flow Modulator (SMFM) in the management of patients with complex thoracoabdominal aortic pathology who are unfit for alternative interventions. METHODS: Biomedical databases were systematically searched for articles published between 2008 and 2015 on the SMFM. A patient-level meta-analysis was used to evaluate aneurysm-related survival. Secondary outcomes were all-cause survival, stroke, spinal cord ischemia, renal impairment, and branch vessel patency. Other considerations were the impact of compliance with the instructions for use (IFU) on clinical outcome. Mean values and Kaplan-Meier estimates are presented with the 95% confidence interval (CI). RESULTS: Fifteen articles (3 multicenter cohort studies, 3 observational cohort studies, and 9 case reports) were included, presenting 171 patients (mean age 68.8±12.3 years; 139 men). The mean aneurysm diameter was 6.7±1.6 cm (95% CI 6.4 to 6.9 cm). Technical success reported in 15 studies was 77.2%. Aneurysm-related survival at 1 year was 78.7% (95% CI 71.7% to 84.4%). One-year all-cause survival was 53.7% (95% CI 46.0% to 61.3%). There were no reported cases of spinal cord ischemia, renal insult, or stroke. CONCLUSION: The SMFM can be safely utilized in some patients with complex thoracoabdominal pathologies provided operators adhere to the IFU. The SMFM is a novel technology with no long-term published data on its sustained effectiveness and a lack of comparative studies. Randomized clinical trials, registries, and continued assessment are essential before this flow-modulating technology can be widely disseminated.