Anticoagulants for the treatment of isolated lower limb superficial vein thrombosis a Bayesian network meta-analysis of randomized controlled trials.

OBJECTIVE: Assess the safety and efficacy of anticoagulants in treating isolated superficial vein thrombosis (iSVT). MATERIALS AND METHODS: A systematic review was conducted according to PRISMA 2020 guidelines, for randomized controlled trials (RCTs) investigating anticoagulants in the treatment of iSVT. The primary endpoint of thrombotic complications encompassed any incident of iSVT progression/recurrence and the development of new-onset (deep vein thrombosis) DVT or (pulmonary embolism) PE. RESULTS: Eight RCT's and 4721 patients treated once daily with either fondaparinux 2.5 mg, rivaroxaban 10 mg, therapeutic, intermediate, and prophylactic low molecular weight heparin (LMW) were included. While all anticoagulants displayed a statistically significant risk reduction compared to placebo in terms of thrombotic complications and iSVT progression/recurrence, only fondaparinux reduced the risk for DVT/PE. Additionally, fondaparinux exhibited enhanced efficacy in decreasing DVT/PE events relative to prophylactic and therapeutic LMWH. Furthermore, rivaroxaban and fondaparinux demonstrated superior outcomes in terms of preventing thrombotic complications compared to all three dosing regimens of LMWH without significant differences between the two, risk ratio RR 1.00(95%CI:0.51-1.92). SUCRA identified fondaparinux as the most effective treatment regarding thrombotic complications, (SUCRA,91.6) and DVT/PE, (SUCRA,96) and rivaroxaban in terms of iSVT progression/recurrence (SUCRA,94.68). Ultimately and despite certain model limitations, meta-regression analysis suggested a possible trend towards improved outcomes with longer treatment durations for thrombotic complications ß = -0.34(95%CI:-16.39to12.23). CONCLUSIONS: Despite inherent limitations such as variations in treatment durations and follow-up periods, this review displayed the efficacy of fondaparinux, rivaroxaban and LMWH in treating iSVT. The improved efficacy of fondaparinux over therapeutic LMWH in terms of DVT/PE outcomes necessitates cautious interpretation underscoring the need for further investigation through adequately powered RCTs.

Covered Stents Versus Bare Metal Stents in the Treatment of Aorto-iliac Disease: A Systematic Review and Individual Participant Data Meta-analysis.

OBJECTIVE: To assess the comparative safety and efficacy of covered stents (CS) and bare metal stents (BMS) in the endovascular treatment of aorto-iliac disease in patients with peripheral arterial disease. DATA SOURCES: A systematic review was conducted adhering to the PRISMA 2020 and PRISMA for Individual Participant Data 2015 guidelines. REVIEW METHODS: A search of PubMed, Scopus, and Web of Science for articles published by December 2023 was performed. The primary endpoint was primary patency. Certainty of evidence was assessed via the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. RESULTS: Eleven studies, comprising 1 896 patients and 2 092 lesions, were included. Of these, nine studies reported on patients' clinical status, with 35.5% classified as Rutherford 4 - 6. Overall primary patency for CS and BMS at 48 months was 91.2% (95% confidence interval [CI] 84.1 - 99.0%) (GRADE, moderate) and 83.5% (95% CI 70.9 - 98.3%) (GRADE, low). The one stage individual participant data meta-analyses indicated a significant risk reduction for primary patency loss favouring CS (hazard ratio [HR] 0.58, 95% CI 0.35 - 0.95) (GRADE, very low). The 48 month primary patency for CS and BMS when treating TransAtlantic Inter-Society Consensus (TASC) C and D lesions was 92.4% (95% CI 84.7 - 100%) (GRADE, moderate) and 80.8% (95% CI 64.5 - 100%) (GRADE, low), with CS displaying a decreased risk of patency loss (HR 0.39, 95% CI 0.27 - 0.57) (GRADE, moderate). While statistically non-significant differences were identified between CS and BMS regarding technical success, 30 day mortality rate, intra-operative and immediate post-operative procedure related complications, and major amputation, CS displayed a decreased re-intervention risk (risk ratio 0.59, 95% CI 0.40 - 0.87) (GRADE, low). CONCLUSION: This review has illustrated the improved patency of CS compared with BMS in the treatment of TASC C and D lesions. Caution is advised in interpreting overall primary patency outcomes given the substantial inclusion of TASC C and D lesions in the analysis. Ultimately, both stent types have demonstrated comparable safety profiles.

Endovenous laser ablation (EVLA) 980 nm versus 1470 nm and the impact of fiber type: a systematic review and meta-analysis.

We sought to assess the efficacy and safety of endovenous laser ablation utilizing a 980 nm device versus a 1470 nm device in the treatment of lower limb venous insufficiency. We performed a systematic review adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement. A research on PubMed, Scopus and Web of science for articles published by January 2024 was conducted. The primary endpoint was great saphenous vein (GSV) and truncal vein occlusion. Eleven studies encompassing 3061 patients and 3193 truncal veins, were included. The 1470 nm device demonstrated superior truncal vein and GSV occlusion outcomes compared to the 980 nm device at the early, one-year, and medium to long-term follow-up intervals. Odds ratios (OR) were 2.79(95%CI:1.31-5.94), 2.22(95%CI:1.21-4.07), and 2.02(95%CI:1.24-3.29) for truncal veins and 2.54(95%CI:1.119-5.41), 2.06(95%CI:1.07-3.95) and 2.04(95%CI:1.25-3.33) for GSV, across the respective intervals. While both devices demonstrated minimal, deep vein thrombosis (DVT), endovenous heat-induced thrombosis (EHIT) ≥ 2, and burn estimates, the 1470 nm device exhibited improved paresthesia, risk ratio (RR), 0.51(95%CI:0.34-0.77) and pain outcomes, standardized mean difference (SMD), -0.62(95%CI:-0.99to-0.25). Subgroup analysis displayed enhanced occlusion outcomes with the 1470 nm device for the six-month and one-year intervals, irrespective of fiber type. Radial fibers were associated with improved paresthesia outcomes (ß=-0.9520,p = 0.03). This review emphasized the enhanced efficacy of the 1470 nm device over the 980 nm device, regardless of fiber type. Radial fibers showed promise for improved paresthesia outcomes, suggesting similar safety profiles for both systems. Conclusive remarks on pain outcomes were impeded by data limitations.

Long-Term Outcomes of Anatomical and Extra-Anatomical Bypass for the Treatment of Unilateral Iliac Artery Lesions a Systematic Review Aggregated Data and Individual Participant Data Meta-Analysis.

BACKGROUND: We investigated the long-term safety and efficacy of anatomical and extra-anatomical bypass for the treatment of unilateral iliac artery disease. METHODS: A systematic search on PubMed, Scopus and Web of science for articles published by June 2023 was performed. We implemented a 2-stage individual participant data meta-analysis and pooled survival probabilities using the multivariate methodology of DerSimonian and Laird. The primary endpoint was primary patency at 5 and 10 years of follow-up. RESULTS: Ten studies encompassing 1,907 patients were included. The 5- and 10-year pooled patency rates for anatomical bypass were 83.27% (95% confidence interval (CI): 69.99-99.07) and 77.30% (95% CI: 60.32-99.04), respectively, with a mean primary patency time representing the duration individuals remained event-free for 10.08 years (95% CI: 8.05-10.97). The 5- and 10-year pooled primary patency estimates for extra-anatomical bypass were 77.02% (95% CI: 66.79-88.80) and 68.54% (95% CI: 53.32-88.09), respectively, with a mean primary patency time of 9.25 years, (95% CI: 7.21-9.68). Upon 2-stage individual participant data meta-analysis, anatomical bypass displayed a decreased risk for loss of primary patency compared to extra-anatomical bypass, hazard ratio 0.51 (95% CI: 0.30-0.85). The 5- and 10-year secondary patency estimates for anatomical bypass were 96.83% (95% CI: 90.28-100) and 96.13% (95% CI: 88.72-100), respectively. The 5- and 10-year secondary patency estimates for extra-anatomical bypass were 91.39% (95% CI: 84.32-99.04) and 85.05% (95% CI: 74.43-97.18), respectively, with non-statistically significant difference between the 2 groups. The 5- and 10-year survival for patients undergoing anatomical bypass were 67.99% (95% CI: 53.84-85.85) and 41.09% (95% CI: 25.36-66.57), respectively. The 5- and 10-year survival for extra-anatomical bypass were 70.67% (95% CI: 56.76-87.98) and 34.85% (95% CI: 19.76-61.44), respectively. The mean survival time was 6.92 years (95% CI: 5.56-7.89) for the anatomical and 6.78 years (95% CI: 5.31-7.63) for the extra-anatomical groups. The pooled overall 30-day mortality was 2.32% (95% CI: 1.12-3.87) with metaregression analysis displaying a negative association between the year of publication and mortality (ß =-0.0065, P < 0.01). Further analysis displayed a 30-day mortality of 1.29% (95% CI: 0.56-2.26) versus 4.02% (95% CI: 1.78-7.03), (P = 0.02) for studies published after and before the year 2000. Non-statistically significant differences were identified between the 2 groups concerning long-term and 30-day mortality outcomes. CONCLUSIONS: While we have demonstrated favorable long-term primary and secondary patency outcomes for both surgical techniques, anatomical bypass exhibited a reduced risk of primary patency loss potentially reflecting its inherent capacity to circumvent the anticipated disease progression in the distal aorta and the contralateral donor artery. The reduction in perioperative mortality observed in our review, coupled with the anachronistic demographic characteristics and inclusion criteria presented in the existing literature, underscores the imperative necessity for contemporary research.

Aluminum potassium sulfate and tannic acid (ALTA) sclerotherapy for hemorrhoidal disease: a systematic review and meta-analysis.

BACKGROUND: We conducted a systematic review to assess the safety and efficacy of Aluminum potassium sulfate and tannic acid (ALTA) sclerotherapy for the treatment of hemorrhoidal disease. METHODS: Our study was conducted in accordance with the PRISMA statement (Preferred Reporting Items for Systematic Reviews and Meta-analyses) 2020. Primary endpoints included overall recurrence and type of recurrence while secondary endpoints included postoperative complications, reintervention, presence of rectal ulcer, rectal stricture, defecation abnormalities and perianal abscess. Α regression analysis, where the percentage of patients with grade II, III and IV hemorrhoidal disease was used as a covariate, was also performed. RESULTS: Twelve studies with 4249 patients met all the inclusion criteria and were eventually included. The crude and pooled estimates of the overall recurrence and complications by the end of follow-up were 10% (95% CI, 6.52%-14.08%) and 5.20% (95% CI, 2.59%-8.52%), respectively. Regression analysis displayed no correlation between recurrence and the grade of hemorrhoid disease II, ß= -0.0012 (95% CI, -0.0074 to 0.0049) (p = .64), grade III ß= -0.0006 (95% CI, -0.0056 to 0.0045) (p = .79) and grade IV ß = 0.0025 (95% CI, -0.0075 to 0.0124). However, a trend suggestive of increased recurrence was observed in patient populations with a higher proportion of grade IV disease. CONCLUSION: ALTA sclerotherapy may be a safe and viable alternative for patients with hemorrhoidal disease. Long-term follow-up and high-quality randomized controlled trials will help define the place of ALTA sclerotherapy in the armamentarium of treatment of hemorrhoids.

Trans-Carotid Artery Revascularization Versus Carotid Endarterectomy in Patients With Carotid Artery Disease: Systematic Review and Meta-analysis of 30-day Outcomes.

This systematic review and meta-analysis compared trans-carotid artery revascularization (TCAR) as an alternative approach to carotid endarterectomy (CEA) in patients with carotid artery disease. An electronic search was conducted using PubMed, Scopus, and Cochrane databases including comparative studies with patients who underwent either TCAR or CEA. This meta-analysis is according to the recommendations of the PRISMA statement. Eight studies met our eligibility criteria, incorporating 7,606 and 7,048 patients in the TCAR and CEA groups, respectively. Thirty-day mortality (odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.56-1.56, P = .81) and stroke (OR: 0.92, 95%CI 0.70-1.22, P = .57) were similar between the two groups, with low heterogeneity. The odds of myocardial infarction (OR: 1.79, 95% CI: 1.18-2.71, P = .01) and cranial nerve injury were significantly higher in patients undergoing CEA compared with TCAR (OR: 4.11, 95% CI: 2.59-6.51, P < .001). The subgroup analysis according to symptomatic pre-intervention status revealed no statistically significant difference regarding 30-day mortality (symptomatic OR: 0.91, 95% CI: 0.40-2.07, P = .82, asymptomatic OR: 0.93, 95% CI: 0.46-1.86, P = .83) and stroke (symptomatic OR: 0.88, 95% CI:0.47-1.64, P = .68, asymptomatic OR: 0.93, 95% CI: 0.64-1.35, P = .70). TCAR offers an alternative treatment for patients with carotid artery stenosis with comparable to CEA mortality and stroke rates during a 30-day post-operative period.

Diagnostic accuracy of ultrasound versus X-ray for distal forearm fractures in children and adolescents: a systematic review and meta-analysis.

PURPOSE: Utilizing ultrasound for the detection of distal forearm fractures in children presents a potential safe and radiation-free alternative compared to X-ray. METHODS: A systematic review was undertaken to compare the diagnostic accuracy of ultrasound in detecting distal forearm fractures in children with X-ray imaging within the period spanning January 2010 to August 2023. The electronic databases MEDLINE and Cochrane CENTRAL were utilized for data retrieval. The QUADAS-2 tool was employed to assess the quality of the included studies. Subsequent statistical analysis was performed to calculate pooled sensitivity and specificity, positive and negative likelihood ratios, as well as the diagnostic odds ratio. RESULTS: Our meta-analysis included seventeen studies, encompassing a total of 2003 patients, 2546 ultrasound scans, and 1203 fracture cases as identified by the reference test (X-ray). The pooled sensitivity and specificity were 0.96 (95% CI: 0.93-0.98) and 0.96 (95% CI: 0.89-0.98), respectively. The positive likelihood ratio was 13.40 (95% CI: 7.97-21.50), the negative likelihood ratio was 0.06 (95% CI: 0.04-0.1), and the pooled diagnostic odds ratio was 209 (95% CI: 92.20-412.00). Our statistical analysis revealed low heterogeneity within our studied cohort. CONCLUSIONS: Our study indicates that ultrasound exhibits exceptionally high accuracy in the detection of distal forearm fractures in children and adolescents. It can be employed safely to either confirm or rule out a fracture, thus circumventing the need for potentially harmful radiation exposure in this vulnerable population. Future research endeavors should focus on establishing a universally accepted protocol for training and scanning methods to standardize practices and eliminate disparities in diagnostic procedures.

Covered endovascular reconstruction of the aortic bifurcation: A systematic review aggregated data and individual participant data meta-analysis.

BACKGROUND: We investigated the early and midterm efficacy and safety of covered endovascular reconstruction of the aortic bifurcation (CERAB) in the treatment of aortoiliac disease (AID). METHODS: A systematic search on PubMed, Scopus, and Web of Science for articles published by August 2023 was performed. The primary end points were primary patency and secondary patency. RESULTS: Eleven retrospective case series, involving 579 patients, were incorporated in the review with 88.9% of the included lesions being categorized as Trans-Atlantic Inter-Society Consensus (TASC) C or D. The pooled primary patency estimates at 12, 24 and 36 months were 94.4% (95% confidence interval [CI], 89.4-99.7), 84.4% (95% CI, 72.3-98.5) and 83.8% (95% CI, 71.4-98.3) respectively. The mean primary patency time, representing the period during which individuals remained event-free, was 51.9 months (95% CI, 43.6-55.4). The pooled 36 months primary patency for studies with a predominantly claudicant patient population (>75% of patients) was 89.4% (95% CI, 78.5-100.0), compared with 71.5% (95% CI, 45.6-100.0) for studies with a mixed population (50% of patients). The pooled 36 months primary patency for studies with a predominantly TASC D patient population (>82% of patients) was 70.4% (95% CI, 46.4-100.0) compared with 91.0% (95% CI, 79.1-100.0) for studies with a more homogenous cohort. The pooled secondary patency estimates at 12, 24, and 36 months were 98.6% (95% CI, 96.2-100.0), 97% (95% CI, 93.1-100.0), and 97% (95% CI, 93.1-100.0), respectively. The pooled technical success, 30-day mortality and 30-day systemic complications estimates were 95.9% (95% CI, 93.7- 97.4), 1.9% (95% CI, 1.0-3.5), and 6.4% (95% CI, 4.4-9.1), respectively. The pooled intraoperative and postoperative 30-day CERAB-related complications estimates were 7.3% (95% CI, 2.0-23.0) and 4.2% (95% CI, 0.7-21.0), respectively. The pooled major amputation and target lesion reinterventions by the end of follow-up were 1.9% (95% CI, 1.0-3.4) and 13.9% (95% CI, 9.9-19.2), respectively. The pooled access site complication estimate was 11.7% (95% CI, 5.9-21.7). CONCLUSIONS: Although this review has showcased the safety and feasibility of the CERAB technique in treating AID, it has also highlighted the necessity for a close and prolonged follow-up period extending beyond 1 year. Moreover, the favorable secondary patency estimates predominantly attained via endovascular reinterventions emphasize a potentially advantageous characteristic of the CERAB technique, particularly valuable when addressing late-stage AID disease or anatomically complex lesions.

A Systematic Review Network Meta-Analysis and Meta-Regression on Surgical and Endovenous Interventions for the Treatment of Lower Limb Venous Ulcer Disease.

BACKGROUND: Venous leg ulcer (VLU) disease constitutes the most severe form of chronic venous insufficiency. We performed a network meta-analysis and meta-regression to investigate the efficacy and safety of the various available interventions in the treatment of VLU. METHODS: We conducted a systematic research corresponding to the instructions by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for studies reporting on surgical or endovenous interventions for the treatment of VLU. Following data extraction, we performed a Bayesian network meta-analysis and meta-regression. Primary endpoints included VLU healing and recurrence. The secondary endpoint was postintervention complications. RESULTS: Seventeen studies evaluating the impact of compression monotherapy, radiofrequency ablation (RFA), endovenous laser ablation (EVLA), sclerotherapy, and saphenous vein surgery on VLU treatment, consisting of 2156 patients (2186 VLU) were included. When compared to compression monotherapy, RFA was the only treatment displaying a statistically-significant impact on ulcer healing, odds ratio (OR) 5.80 (95% credibility interval (CI): 1.08-35.07), while EVLA, RR 0.06 (95% CI: 0.00-0.57), sclerotherapy, RR 0.07 (95% CI: 0.00-0.68) and RFA, RR 0.12 (95% CI: 0.01-0.91) were the 3 interventions reducing VLU recurrence. EVLA (SUCRA, 69.65) ranked as the most efficient intervention concerning ulcer recurrence reduction. Regarding postintervention complications, EVLA was the only intervention displaying a statistically-significant increased risk compared to compression monotherapy, RR 14.3 (95% CI: 2.03-172.56). Meta-regression analysis exploring the impact of perforator treatment on VLU failed to predict healing, ß = -0.27 (95% CI: -2.55 to 1.85), recurrence, ß = -0.02 (95% CI: -2.96 to 2.75) and complication outcomes, ß = -0.089 (95% CI: -3.13 to 2.85). During sensitivity analysis, RFA and sclerotherapy failed to sustain their effects on ulcer healing and ulcer recurrence, respectively. In addition, sclerotherapy displayed statistically-significant inferior outcomes compared to both EVLA and RFA regarding ulcer recurrence. CONCLUSION: This is the first network meta-analysis examining the effect of various interventions on VLU disease. While we have demonstrated the efficacy of RFA and ELVA in ulcer recurrence prevention, our results regarding the impact of RFA and sclerotherapy on VLU healing and recurrence, respectively, should be interpreted with caution. In addition, this review raises questions concerning the value of surgery and perforator interventions in the treatment of VLU. Further research through randomized controlled trials is required. CLINICAL IMPACT: Our review has revealed the significant efficacy of endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in effectively reducing the incidence of ulcer recurrence when compared to compression monotherapy. These outcomes hold the potential to provide relevant insights to both medical practitioners and patients, thereby informing a more prudent and enlightened decision-making approach. Such informed decisions, aimed at mitigating the recurring occurrence of venous leg ulcers, carry profound significance given the considerable socioeconomic implications associated with this medical condition.

Endovenous thermal ablation in the treatment of large great saphenous veins of diameters > 12 mm: A systematic review meta-analysis and meta-regression.

BACKGROUND: We sought to assess the safety and efficacy of endovenous thermal ablation (EVTA) in treating large great saphenous veins (GSV) > 12 mm in diameter. METHODS: We performed a systematic review according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 for comparative and noncomparative studies depicting EVTA in the treatment of GSV > 12 mm. Primary endpoints included GSV occlusion, technical success, deep vein thrombosis (DVT), and endovenous heat-induced thrombosis (EHIT). We conducted a comparative analysis between GSV > 12 mm and < 12 mm and a meta-regression analysis for two sets of studies, one including the whole dataset, containing treatment arms of comparative studies with GSV < 12 mm and one exclusively for GSV > 12 mm. RESULTS: Seven studies, including 2564 GSV, depicting radiofrequency (RFA) and endovenous laser ablation (EVLA) were included. GSV > 12 mm occlusion, technical success, DVT, and EHIT estimates were 95.9% (95% CI: 93.6-97.8), 99.9% (95% CI: 98.9-100.0), 0.04% (95% CI: 0.0-3.4), and 1.6% (95% CI: 0.3-3.5). Meta-regression revealed a negative association between GSV diameter and occlusion for both the whole dataset (p < 0.01) and the > 12 mm groups (p = 0.04), GSV diameter and technical success for both groups (p < 0.01), (p = 0.016), and GSV diameter and EHIT only for the whole dataset (p = 0.02). The comparative analysis between GSV < 12 mm and GSV > 12 mm displayed an occlusion estimate of OR 1.79 (95% CI: 1.25-2.56) favoring small GSV. CONCLUSION: Whereas we have displayed excellent occlusion and technical success results for the EVTA of GSV > 12 mm, our analysis has illustrated the unfavorable impact of GSV diameter on occlusion, technical success, and EHIT outcomes regardless of the 12 mm threshold. Potential parameter or device adjustments in a diameter-oriented fashion could further enhance outcomes.

Interventions For the Treatment of Lower Limb Telangiectasias and Reticular Veins: A Systematic Review and Network Meta-Analysis.

OBJECTIVE: To assess the safety and efficacy of available interventions in the treatment of lower limb reticular veins and telangiectasias. DATA SOURCES: An electronic search was performed on Scopus, Embase, and Google scholar. REVIEW METHODS: A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Following data extraction and processing, a Bayesian network meta-analysis and meta-regression was undertaken. The primary endpoint was telangiectasia and reticular vein clearance. RESULTS: Nineteen studies, 16 randomised controlled trials and three prospective case series, including 1 356 patients and 2 051 procedures, were finally incorporated. All interventions, apart from 0.5% sodium tetradecyl sulphate (STS) and 0.25% STS displayed statistically significantly superior telangiectasia and reticular vein clearance compared with normal saline (N/S), Meta-regression analysis employing the type of the venule treated (telangiectasia or reticular vein) as a covariable, revealed a positive correlation between Nd:YAG 1064 nm laser and telangiectasia clearance (ß = 1.38, 95% CI 0.56 - 2.14). Further exploration unveiled the superiority of Nd:YAG 1064 nm in the treatment of telangiectasias compared with all included interventions except 72% chromated glycerin (CG). STS 0.25% increased the risk of hyperpigmentation compared with all interventions except 0.5% STS, and 1% polidocanol. CG 72% decreased the risk of matting compared with polidocanol foam (risk ratio [RR] 0.14, 95% CI 0.02 - 0.80) and STS (RR 0.31, 95% CI 0.07 - 0.92). Non-statistically significant differences were identified between interventions regarding pain outcomes. CONCLUSION: This network meta-analysis has demonstrated a proportional relationship between sclerosant potency and side effect occurrence in the treatment of telangiectasias and reticular veins and the superiority of laser therapy compared with injection sclerotherapy in treating telangiectasias. The transition of telangiectasia and reticular vein treatment from highly potent detergent solutions to equally effective but milder sclerosants could potentially reduce undesirable adverse events.

Single Branched Endografts for the Preservation of Left Subclavian Artery in the Treatment of Zone II Thoracic Aortic Lesions a Systematic Review and Meta-Analysis.

BACKGROUND: We investigated the safety and feasibility of single branched endografts in the treatment of zone II thoracic endovascular aortic repair (TEVAR). METHODS: We performed a systematic research on Medline, Scopus and EMBASE for articles published up to February 2023. Primary end points included technical success, 30-day mortality, stroke and spinal cord injury (SCI) as well as unassisted left subclavian artery (LSA) branch patency by the end of follow-up. Secondary end points included early 30-day and persistent endoleaks, new onset dissection and reintervention by the end of follow-up. RESULTS: Fourteen studies, three prospective case series and 11 retrospective case series comprised of 727 patients were finally included. The pooled technical success and 30-day mortality rates were 94.86 % (95% confidence interval (CI): 90.95-97.86) and 0.14% (95% CI: 0.00-0.87). The 30-day stroke and SCI rates were 0.45% (95% CI: 0.00-1.39) and 0.08% (95% CI: 0.00-0.99), respectively, while the unassisted LSA branch patency estimate was 99.12% (95% CI: 97.97-99.86). The early 30-day and persistent endoleak rates were 5.19% (95% CI: 2.45-8.65) and 2.57% (95% CI: 0.36-6.02), whereas new onset dissections and reinterventions estimates were 0.94% (95% CI: 0.17-2.11) and 2.40% (95% CI: 0.41-5.42). CONCLUSIONS: While we have displayed the safety and feasibility of single branched endografts in the treatment of zone II thoracic aortic lesions, physicians should be aware of the persistency displayed by early type I endoleaks eventually requiring reintervention. The variations in device and lesion characteristics accompanied by the short-term follow-up presented in our review do not allow for definite conclusions to be drawn, necessitating further research through high-quality randomized controlled trials.

A network meta-analysis on the efficacy and safety of thermal and nonthermal endovenous ablation treatments.

OBJECTIVE: We assessed the mid-term efficacy and safety of thermal and nonthermal endovenous ablation for the treatment of lower limb superficial venous insufficiency. METHODS: We performed a systematic review in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement and a Bayesian network meta-analysis. The primary end points were great saphenous vein (GSV) closure and venous clinical severity score (VCSS) improvement. A meta-regression using GSV diameter as a covariate was undertaken for the two primary end points. RESULTS: We included 14 studies and 4177 patients, with a mean follow-up of 25.7 months. Radiofrequency ablation (RFA; odds ratio [OR], 3.99; 95% confidence interval [CI], 1.82-10.53), cyanoacrylate ablation (CAC; OR, 3.09; 95% CI, 1.35-8.37), and endovenous laser ablation (EVLA; OR, 2.72; 95% CI, 1.23-7.38) displayed increased odds for GSV closure compared with mechanochemical ablation (MOCA). MOCA inferiority compared with RFA (mean difference [MD], 0.96; 95% CI, 0.71-1.20), EVLA (MD, 0.94; 95% CI, 0.61-1.24), and CAC (MD, 0.89; 95% CI, 0.65-1.15) was also depicted regarding VCSS improvement. EVLA resulted in an increased risk of postoperative paresthesia compared with MOCA (risk ratio [RR], 9.61; 95% CI, 2.32-62.29), CAC (RR, 7.90; 95% CI, 2.44-38.16), and RFA (RR, 6.96; 95% CI, 2.31-28.04). Although the overall analysis identified nonstatistically significant differences for Aberdeen varicose vein questionnaire score improvement, thrombophlebitis, ecchymosis, and pain, further investigation revealed an increase pain profile for EVLA at 1470 nm compared with RFA (MD, 3.22; 95% CI, 0.93-5.47) and CAC (MD, 3.04; 95% CI, 1.05-4.97). A sensitivity analysis displayed a persistent underperformance of MOCA compared with RFA (OR, 4.33; 95% CI, 1.15-55.54) for GSV closure and both RFA (MD, 0.99; 95% CI, 0.22-1.77) and CAC (MD, 0.84; 95% CI, 0.08-1.65) regarding VCCS improvement. Although no regression model reached statistical significance, the GSV closure regression model revealed a trend for considerably decreased efficacy for both CAC and MOCA with larger GSV diameters compared with RFA and EVLA. CONCLUSIONS: Although our analysis has produced skepticism regarding the efficacy of MOCA in the mid-term period for VCSS improvement and GSV closure rates, CAC showed equivalent results compared with both RFA and EVLA. Additionally, CAC displayed a decreased risk of postprocedural paresthesia and pigmentation and induration compared with EVLA. Also, both RFA and CAC had an improved pain profile compared with EVLA 1470 nm. The potential underperformance of nonthermal, nontumescent ablation modalities in ablating large GSVs necessitates further research.

A systematic review and meta-analysis of GLASS staging system in the endovascular treatment of chronic limb-threatening ischemia.

OBJECTIVE: The objective of this study was to evaluate the application of the Global Anatomic Staging System (GLASS) in the endovascular treatment of chronic limb-threatening ischemia (CLTI). METHODS: We performed systematic research between June 2019 and February 2022, including articles investigating the relationship of GLASS classification with the outcomes of endovascular interventions in the treatment of CLTI. Data from the included studies were pooled and meta-analyzed. The primary endpoints were limb-based patency (LBP) at 1-year follow-up and immediate technical failure (ITF). Secondary endpoints included major amputation. We performed subgroup analysis between studies that reported on calcium modifier inclusion during GLASS classification and studies that did not. RESULTS: Eleven studies, including 1816 patients (1975 limbs) met the inclusion criteria. The pooled ITF rates for GLASS stages I, II, and III are 5.52% (95% confidence interval [CI], 3.74%-8.07%), 7.39% (95% CI, 5.32%-10.18%), and 21.07% (95% CI, 13.48%-31.39%) respectively. The pooled LBP for GLASS stages I, II, and III are 68.43% (95% CI, 53.44%-80.37%), 41.52% (95% CI, 18.91%-68.37%), and 38.64% (95% CI, 19.83%-61.57%). The relative risk (RR) for ITF regarding composite GLASS I and II stages vs GLASS III is 3.96 (95% CI, 1.96-7.98). The RR for LBP of GLASS I and II versus GLASS stage III is 1.51 (95% CI, 0.86-2.64). Pooled major amputation rates for the composite GLASS I, II and GLASS III stages are 7.62% (95% CI, 5.44%-10.58%) and 15.43% (95% CI, 11.72%-20.05%) respectively, whereas the RR between GLASS I, II, and GLASS III stages is 1.84 (95% CI, 1.18-2.87). CONCLUSIONS: Our study demonstrated that patients with CLTI undergoing endovascular interventions classified as GLASS stage III had almost a four-fold risk increase for ITF and 1.84 times the risk of major amputation compared with stages I and II. Additionally, GLASS classification correctly predicted ITF for all three stages, whereas it failed to predict stage I and II LBP outcomes. Safe conclusions regarding LBP cannot be drawn due to the low quality and small number of the included studies, necessitating further research. Furthermore, we displayed the importance of calcium moderator inclusion in the accurate classification of GLASS.

A systematic review aggregated data and individual participant data meta-analysis of percutaneous endovascular arteriovenous fistula.

OBJECTIVE: To assess the short-term and mid-term safety and efficacy of percutaneous endovascular arteriovenous fistula (pAVF) creation. METHODS: A systematic search was implemented corresponding to the PRISMA 2020 and the PRISMA for individual participant data (IPD) systematic reviews 2015. Aggregated data from the included studies were obtained and meta-analyzed regarding both the overall pAVF efficacy and the comparison of pAVF with surgical AVF (sAVF). We performed a two-stage IPD meta-analysis for studies comparing pAVF and sAVF regarding primary and secondary patency. Primary end points included primary patency, secondary patency, and functional cannulation. RESULTS: Eighteen studies with 1863 patients were included. The overall pAVF, primary patency, secondary patency, functional cannulation and abandonment rates were 54.01% (95% confidence interval [CI], 40.69-66.79), 87.27% (95% CI, 81.53-91.42), 79.94% (95% CI, 65.94-89.13), and 15.58% (95% CI, 7.77-28.79), respectively. The overall pAVF, technical success, maturation, reintervention per person-years and mean time to maturation rates were 97.08% (95% CI, 95.66-98.04), 82.13% (95% CI, 71.64-89.32), 0.80 (95% CI, 0.34-1.47), and 58 days (95% CI, 36.64-92.82), respectively. Secondary patency and pAVF abandonment rates where the only end points were WavelinQ and Ellipsys displayed statistically significant differences of 81.36% (95% CI, 76.15-85.65) versus 92.12% (95% CI, 87.94-94.93) and 32.54% (95% CI, 22.23-44.87) versus 11.13% (95% CI, 4.82-23.65). An IPD meta-analysis of hazard ratios for primary and secondary patency between pAVF and sAVF were 1.27 (95% CI, 0.61-2.67) and 1.25 (95% CI, 0.87-1.80), favoring sAVF. Statistically significant difference between pAVF and sAVF were solely depicted for steal syndrome relative risk of 5.91 (95% CI, 1.12-31.12) and wound infections relative risk of 4.19 (95% CI, 1.04-16.88). Plotting of pAVF smoothed hazard estimate displayed an upsurge in the probability of primary patency failure at 1 month after the intervention. CONCLUSIONS: Although we failed to identify statistically significant differences between pAVF and sAVF regarding any of the primary end points, pAVF displayed a decreased risk for steal syndrome and wound infection. Although both the Ellipsys and WavelinQ devices displayed satisfactory secondary patency rates, Ellipsys demonstrated a statistically significant improved rate compared with WavelinQ. Additionally, and despite the borderline statistically insignificant inferior reintervention rate displayed by WavelinQ, one in three WavelinQ pAVFs resulted in abandonment. The introduction of pAVF as a treatment modality calls for standardized definition adjustment and improvement.

A Systematic Review and Meta-Analysis of Carotid Artery Stenting for the Treatment of Cervical Carotid Artery Dissection.

OBJECTIVE: To assess the efficacy and safety of carotid artery stenting for the treatment of extracranial carotid artery dissection (CAD). DATA SOURCES: Systematic review using Medline, Scopus, EMBASE, and the Cochrane Library. REVIEW METHODS: A systematic search was performed according to the Preferred Reporting Items for Systematic reviews and Meta-analysis statement. Data from the eligible studies were extracted and meta-analysed. Primary endpoints included post-operative mortality, cerebrovascular events (CEs), and modified Rankin Score for neurological disability (mRS) at 90 days. Subgroup analyses were performed between stenting of spontaneous and traumatic CAD, primary stenting vs. stenting after failed medical therapy (FMT), and stenting of CAD in the presence of tandem occlusions vs. stenting of isolated extracranial CAD. RESULTS: Twenty-four studies with 1 224 patients were included. Pooled post-operative mortality, CE, and mRS 0 - 2 rates were 1.71% (95% confidence interval [CI] 0.83 - 2.80), 6.45% (95% CI 2.80 - 11.10), and 76.13% (95% CI 64.15 - 86.50), respectively. The pooled stroke rate was 2.16% (95% CI 0.0 - 6.64). Spontaneous vs. traumatic CAD mortality rates were 3.20% (95% CI 1.80 - 4.88) and 0.00% (95% CI 0.00 - 1.59) while CE rates were 14.26% (95% CI 6.28 - 24.36) and 1.64% (95% CI 0.0 - 6.08). Primary stenting and stenting after FMT mortality rates were 0.63% (95% CI 0.0 - 5.63) and 0.0% (95% CI 0.0 - 2.24), while CE rates were 5.02% (95% CI 0.38 - 12.63) and 3.33% (95% CI 0.12 - 9.03). Mortality rates for tandem occlusions and isolated extracranial CAD were 5.62% (95% CI 1.76 - 10.83) and 0.23% (95% CI 0.0 - 1.88), respectively, while CE rates were 15.28% (95% CI 6.23 - 26.64) and 1.88% (95% CI 0.23 - 4.51). The methodological index for non-randomised studies score was 8.66 (low). CONCLUSION: Both primary stenting and stenting of spontaneous CAD yielded unfavourable results with respect to stent thrombosis and stroke rates. Conversely, stenting following FMT had acceptable mortality and complication rates corroborating the use of stenting in the setting of CAD as a second line treatment. Due to the low quality of the included studies, definite conclusions cannot be drawn necessitating further research.

A systematic review and meta-analysis of periprocedural bridging for patients with mechanical heart valves undergoing non-cardiac interventions.

OBJECTIVE: To evaluate the safety and efficacy of perioperative bridging in patients with mechanical heart valves undergoing non-cardiac interventions. MATERIALS AND METHODS: A systematic research using Medline, EMBASE, and Google Scholar was implemented corresponding to the Preferred Reporting Items for Systematic reviews and Meta-analysis (PRISMA) statement. Data from the eligible studies were obtained and meta-analyzed. Primary endpoints included major bleeding and thromboembolism. Secondary endpoints included minor bleeding, overall mortality, and overall bleeding (major and minor bleeding). We conducted a comparative analysis between bridging and non-bridging along with a sensitivity analysis for patients undergoing major and minor operations. RESULTS: Fifteen studies comprised of 2305 patients (2453 bridging episodes) were included. Pooled major bleeding and thromboembolism rates were 3.85 % (95 % CI: 2.12-5.98) (I2 = 69 %, p < 0.01) and 0.39 % (95 % CI: 0.00-1.41) (I2 = 64 %, p < 0.01). Bridging versus non-bridging major bleeding, thromboembolism, and overall bleeding risk ratios (RR) were RR 2.05 (95 % CI: 0.98-4.28) (I2 = 10 %, p = 0.34), RR 1.63 (95 % CI: 0.41-6.50) (I2 = 0 %, p = 0.63) and RR 1.79 (95 % CI: 1.17-2.72) (I2 = 55 %, p = 0.09) respectively. Subgroup analysis displayed major and minor operation thromboembolism and overall bleeding rates of 3.09 % (95 % CI: 0.78-6.43) (I2 = 0 %, p = 0.89) versus 0.14 % (95 % CI: 0.00-1.40) (I2 = 0 %, p = 0.93), test for subgroup differences (p < 0.01) and 17.37 % (95 % CI: 11.73-23.77) (I2 = 0 %, p = 0.61) versus 28.18 % (95 % CI: 22.80-33.88) (I2 = 0 %, p = 0.47), test for subgroup differences (p = 0.01) respectively. CONCLUSION: Our analysis suggests that bridging may potentially put patients at an increased bleeding risk regarding overall bleeding rates, while failing to provide statistically significant benefits concerning thromboembolism and overall mortality compared to non-bridging. Limitations such as the mixed patient population don't allow for definite conclusions to be drawn warrantying further research through randomized controlled trials.

A Systematic Review Aggregated Data and Individual Participant Data meta-Analysis of Spot Stenting in the Treatment of Lower Extremity Peripheral Arterial Disease.

BACKGROUND: The treatment of infrainguinal peripheral arterial disease often involves complex lesions requiring stent implantation. It is common knowledge that stent length is a negative predictor for restenosis. We investigated the efficacy and safety of spot stenting for the treatment of femoropopliteal lesions. METHODS: We carried out a systematic review for articles published by December 2021 regarding spot stenting in the treatment of peripheral arterial disease. Primary endpoints included primary patency (PP) and freedom from target lesion revascularization (TLR) 12 months postoperatively. We performed a meta-analysis of aggregate data for PP, TLR and technical success and a subgroup analysis between devices dedicated to spot stenting and conventional devices. Following the individual participant data (IPD) extraction, we performed a 2 stage time to event IPD meta-analysis for PP and TLR. Plotting of hazard estimates was performed by applying the Epanechnikov Kernel function. RESULTS: Five studies with 818 patients, 965 lesions and a mean lesion length of 169.2 mm were included. Chronic total occlusions comprised 51.7% of the treated lesions while, 80% of the lesions involved the popliteal artery. The pooled PP 12 months post-operatively is 80.72% (95% confidence interval [CI]: 77.67-83.45) (I2 = 36%), 95% prediction interval (PI) (67.94-89.00). The subgroup analysis between devices dedicated to spot stenting and conventional devices produced similar results of 80.93% (95% CI: 77.17-84.19) (I2 = 0%) and 80.30% (95% CI: 74.72-84.90) (I2 = 62%), respectively. The pooled TLR rate is 13.06% (95% CI: 10.69-15.86) (I2 = 53%). The pooled technical success rate is 98.77% (95% CI: 97.50-99.40) (I2 = 18%). The IPD meta-analysis produced statistically significant results favoring spot stenting over long stenting for both primary endpoints. Primary patency hazard ratio (HR) 2.04. (95% CI: 1.25-3.32) (I2 = 0%, t2 = 0). TLR, HR 1.97 (95% CI: 1.02-3.79) (I2 = 0%, t2 = 0). Plotting of hazard estimates produced diametrically opposite courses for the spot and long stenting curves. The hazards cross over at about 6 months, and at about 10 months when long stenting group faces the highest risk for loss of patency, spot stenting hazard reaches near zero values. The curves for TLR portray similar findings. CONCLUSIONS: Spot stenting is a safe and effective strategy for the treatment of femoropopliteal arterial disease with acceptable short and mid-term primary patency and freedom from TLR rates. Long stenting of the femoral artery doubles the risk of patency loss and TLR compared to spot stenting. The risk of patency loss and TLR in femoral artery spot stenting appears 4 months after the intervention and reaches near zero values at 8 months.

A systematic review and meta-analysis of Supera interwoven nitinol stents for the treatment of infrainguinal peripheral arterial disease.

INTRODUCTION: Stenting of infrainguinal lesions can be rather challenging due to the mechanical stress applied on the arteries during motion. We assessed the short-term and mid-term safety and efficacy of Supera interwoven nitinol stent for the treatment of infrainguinal arterial disease. EVIDENCE ACQUISITION: We conducted a systematic review for articles published from December 2011 up to May 2021 regarding studies assessing the safety and efficacy of Supera interwoven nitinol stents for the treatment of infra-inguinal peripheral arterial disease. Studies that involved synchronous application of the Supera stent and drug delivering devices, or any alternative endoprosthesis were excluded. Pooled Kaplan-Meier survival curves and smoothed hazard estimates were generated. Data were meta-analyzed using a random effects model. Primary endpoints included primary patency and freedom from clinically driven target lesion revascularization (TRL). Secondary endpoints included technical success and major amputation at 1 year post intervention. EVIDENCE SYNTHESIS: Seventeen studies with 2015 patients (65.3% males) and a mean lesion length of 137.2 mm were included. Of the total treated lesions, 44.9% involved femoropopliteal artery and 37.4% the popliteal artery. Chronic total occlusions made up 49% of the treated lesions. There were no stent fractures reported. The pooled technical success rate is 99.84% (95% CI: 99.26-100). Pooled major amputation rate at 1 year is 1.48% (95% CI: 0.47-2.87). Pooled primary patency and freedom from TLR rates at 1 year are 83.5% (95% CI: 80.24-86.54) and 90.32% (95% CI: 88.75-91.79), respectively. Pooling of individual patient data produced primary patency and freedom from TLR rates of 84.48% (95% CI: 82.66-86.11) and 90.81% (95% CI: 88.64-92.58) respectively. According to the smoothed hazard ratio estimate the risk for losing primary patency peaked between 4 and 5 months while the risk for TLR peaked between 7 and 8 months after the intervention. CONCLUSIONS: This review and meta-analysis indicated the safety and efficacy of Supera stents for the treatment of challenging infrainguinal lesions in the short-term and mid-term periods, with acceptable primary patency and freedom from TLR rates. Clinicians should be aware that between 4 and 5 months patients face a higher risk for event occurrence.

The Incraft stent graft for the treatment of abdominal aortic aneurysms: an iliac-friendly device with an effective conventional proximal sealing mechanism.

INTRODUCTION: The Incraft aortic stent graft (Cordis, Bridgewater, NJ, USA) is a trimodular endovascular stent graft with a conventional suprarenal active fixation specifically designed to overcome the anatomic limitation of small, stenotic, and tortuous iliac vessels. AREAS COVERED: The present article provides a complete description of the Incraft stent graft, its clinical performance, its technical characteristics as well as a comparison with other competitive endografts. EXPERT OPINION: The Incraft stent graft is an EVAR ultra low-profile device initially designed for overcoming the limitation of the hostile iliac anatomy. Recently, the device is being increasingly used in real-world conditions and not only in complex iliac anatomies with good mid-term results. Whether it remains a useful EVAR toolbox or will become a workhorse endograft is yet to be determined.