Optimal Management of Asymptomatic Carotid Artery Stenosis: A Systematic Review and Network Meta-Analysis.

OBJECTIVE: Management of asymptomatic carotid artery stenosis (ACAS), including carotid endarterectomy (CEA), carotid artery stenting (CAS), and best medical treatment (BMT), remains inconsistent in current practice. Early studies reported a benefit of CEA vs. BMT; however, the current risk-benefit profile of invasive therapy lacks consensus. By evaluating the effects of modern BMT vs. invasive intervention on patient outcomes, this study aimed to influence the future management of ACAS. METHODS: A systematic review and series of network meta-analyses were performed assessing peri-operative (within 30 days) and long term (30 days - 5 years) stroke and mortality risk between ACAS interventions. Total stroke, major, minor, ipsilateral, and contralateral stroke subtypes were assessed independently. Traditional (pre-2000) and modern (post-2000) BMT were compared to assess clinical improvements in medical therapy over the previous two decades. Risks of myocardial infarction (MI) and cranial nerve injury (CNI) were also assessed. RESULTS: Seventeen reports of 14 310 patients with > 50% ACAS were included. CEA reduced the odds of a peri-operative stroke event occurring vs. CAS (odds ratio [OR] 1.6, 95% confidence interval [CI] 1.1 - 2.2 [0 - 20 fewer/1 000]). CEA and CAS reduced the long term odds of minor strokes (OR 0.35, 95% CI 0.21 - 0.59 [20 fewer/1 000]) and ipsilateral strokes (OR 0.27, 95% CI 0.19 - 0.39 [30 fewer/1 000]) vs. all BMT. CEA reduced the odds of major strokes and combined stroke and mortality vs. traditional BMT; however, no difference was found between CEA and modern BMT. CAS reduced the odds of peri-operative MI (OR 0.49, 95% CI 0. 26 - 0.91) and CNI (OR 0.07, 95% CI 0.01 - 0.42) vs. CEA. CONCLUSION: Modern BMT demonstrates similar reductions in major stroke, combined stroke, and mortality to CEA. The overall risk reductions are low and data were unavailable to assess subgroups which may benefit from intervention. However, BMT carries the potential to reduce the requirement for surgical intervention in patients with ACAS.

Outcomes of Saphenous Vein Intervention in the Management of Superficial Venous Incompetence: A Systematic Review and Network Meta-analysis.

OBJECTIVE: To determine the most effective modality of intervention to treat saphenous vein insufficiency. SUMMARY OF BACKGROUND DATA: Endovenous therapies have instigated a paradigm shift in the management of superficial venous incompetence. When compared with open surgery, endovenous interventions (foam sclerotherapy, radiofrequency ablation, endovenous laser ablation (EVLA), mechanochemical ablation, and CAE closure) potentially offer reduced morbidity with similar procedural efficacy. METHODS: A systematic review and series of network meta-analyses of randomized controlled trials were performed assessing risks of procedural failure (within 6-weeks) and recurrence (6-weeks to 5-years), defined by ultrasound, between the different modalities of intervention for superficial venous incompetence. Treatment comparisons addressing risks of common adverse events, venous clinical severity score, and pain were also performed. RESULTS: A systematic search identified 51 articles, describing 36 randomized controlled trials, incorporating 7576 limbs. Outcome data on 10 modalities of intervention were analyzed up to 5-year follow-up. CAE resulted in the lowest risk of procedural failure within 6-weeks. Foam sclerotherapy had the highest risk of recurrence while high ligation with stripping (HLS) and Conservatrice Hemodynamique de l'Insuffisance Veineuse en Ambulatoire were ranked best to reduce long-term recurrence. No intervention increased risks of venous thromboembolism and there was minimal difference in morbidity between treatments. All interventions improved venous clinical severity score (range -1.02 to -4.95), however, radiofrequency ablation demonstrated the greatest improvement, followed by EVLA and HLS between 2 to 5-years. EVLA was associated with the highest risk of pain, while mechanochemical ablation offered the least. CONCLUSIONS: Although CAE offered the lowest risk of initial procedural failure, HLS resulted in lower rates of long-term recurrence without considerably increasing morbidity when compared with other endovenous options.

Eversion Endarterectomy - An Alternative Approach to Occlusive External Iliac Artery disease.

OBJECTIVES: While endovascular intervention is the recommended first option for management of common iliac artery (CIA) lesions, it lacks durable patency for Trans-Atlantic Inter-Society Consensus (TASC)-II C and D lesions involving the external iliac artery (EIA). Aorto-femoral bypass is a durable option but is unsuitable in patients with significant co-morbidities. Eversion endarterectomy provides an alternative to both endovascular and extensive open aortoiliac reconstruction for occlusive EIA disease. MATERIALS AND METHODS: A single-center, retrospective review (2000-2020) of all patients undergoing eversion endarterectomy for EIA disease was undertaken. Demographic, clinical, operative and follow-up data were recorded. RESULTS: Fifty eversion endarterectomies were performed in 47 patients. The median age was 65.0 years (range 46-82) and 66.6% were male. Sixty-eight percent (n = 34) were ASA grade 3. Indications for intervention were disabling claudication (44%) and critical limb ischaemia (56%). Angiography demonstrated 22 TASC C and 28 TASC D lesions. The median follow-up was 18.5 months (range 0-149). The technical success rate was 100%, and 84% (n = 42) experienced an immediate symptomatic improvement. Primary and primary-assisted patency at one, three and five years was 86%, 82% and 74%, and 100%, 96% and 92%, respectively. The five-year limb salvage rate was 96%. Eight limbs required reintervention to maintain patency, either by open (n = 2), endovascular (n = 3) or hybrid approach (n = 3). Thirty-day mortality was 2% (n = 1) with 10% (n = 5) experiencing a procedure-related morbidity. All-cause mortality was 38% (n = 19) during the follow-up period. CONCLUSIONS: Eversion endarterectomy is a safe, effective alternative treatment for occlusive EIA disease. This study reports durable patency at five years and low perioperative morbidity and mortality.

Diagnostic Performance of Ankle-Brachial Pressure Index in Lower Extremity Arterial Disease.

Introduction Ankle-brachial pressure indices (ABIs) continue to form the basis of diagnostics for lower extremity arterial disease (LEAD). However, there remains a paucity of data to support its accuracy. This study aims to evaluate its diagnostic sensitivity and specificity using established arterial-imaging modalities as a benchmark. Methods In this retrospective study, a regional, prospectively maintained, vascular laboratory database was interrogated to identify referred patients with arterial disease who underwent concomitant assessment with ABI and lower limb arterial duplex ultrasound (DUS). Duplex acted as the reference standard. Those who had peripheral computed tomography angiogram (CTA) within 3 months of initial assessment were included in a subgroup analysis to correlate ABI with CTA. The primary end point was the sensitivity and specificity of ABI compared with DUS as the reference standard. Results Concomitant assessment was performed in 438 limbs (250 patients) over a 27-month period. The ABI was normal (0.9 to 1.4) in 196 limbs (44.9%) and abnormal in the remaining 241 limbs (55.1%). False-positive results occurred in 83 out of 241 limbs (34.4%), and false-negative results occurred in 54 limbs out of 196 (27.5%). True-positive results were 158 out of 241 limbs (65.6%), whereas true-negative results were 142 out of 196 limbs (72.4%). ABI using DUS as a benchmark identified a sensitivity for peripheral artery disease of 72.3% and a specificity of 69.3%. Concomitant CTA imaging was available in 200 limbs. The sensitivity and specificity of ABI correlated with CTA were 65.5 and 68.8%, respectively. Conclusion ABIs have a moderate predictive value in the diagnosis of LEAD. Normal range outcomes cannot be taken to infer the absence of LEAD and, as such, further arterial imaging in the form of DUS or angiography should be strongly considered in those with suspected underlying disease requiring intervention. Further noninvasive tests such as exercise studies or pulse volume waveforms should be considered, if diagnostic uncertainty exists, in those requiring nonoperative intervention and risk factor control.

DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers.

BACKGROUND: Venous leg ulceration is a widespread, debilitating pathology with high recurrence rates. Conservative treatment using graduated compression dressings may be associated with unacceptable ulcer recurrence rates. Early superficial venous ablation encourages ulcer healing and reduces recurrence. However, many of this cohort display concomitant ilio-caval stenosis, which further contributes to lower limb venous hypertension and ulceration. An approach that combines early superficial venous ablation with early treatment of ilio-caval stenotic disease may significantly improve ulcer healing and recurrence rates. We question whether early iliac vein interrogation with intravascular ultrasound (IVUS), stenting of significant occlusive disease plus superficial venous ablation, in patients with active venous leg ulceration, will produce superior ulcer healing to standard therapy. METHODS: This is a prospective, multi-centre, randomised controlled, feasibility trial recruiting patients with lower limb venous ulceration and saphenous venous incompetence. Patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (> 50%) iliac vein lesions plus compression therapy. The primary feasibility outcome will be the rate of eligible patient participation while the primary clinical outcomes will be ulcer healing and procedural safety. Secondary outcomes include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. Follow-up will be over a 5-year period. This feasibility trial is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the trial to definitively address ulcer-healing rates. DISCUSSION: This trial will be the first randomised trial to examine the role iliac interrogation and intervention in conjunction with standard operative therapy in the management of venous ulceration related to superficial truncal venous incompetence. ETHICAL COMMITTEE REFERENCE: C.A. 2111 Galway Clinical Research Ethics Committee REGISTRATION: Clinical Trials.gov registration NCT03640689 , Registered on 21 August 2018.

Endoscopic management versus transanal surgery for early primary or early locally recurrent rectal neoplasms-a systematic review and meta-analysis.

BACKGROUND: Both endoscopic techniques and transanal surgery are viable options that allow organ preservation for early rectal neoplasms. Whilst endoscopic approaches are less invasive and carry less morbidity, it is unclear whether they are as oncologically effective. AIM: To compare endoscopic techniques with transanal surgery in the management of early rectal neoplasms. METHODS: A systematic literature search was performed for randomised and observational studies comparing these techniques. The pre-specified main outcomes measured were en bloc and R0 resection rates and recurrence. Pair-wise meta-analysis was performed. RESULTS: This review included 1044 patients. Transanal surgery had increased R0 resection rates (odds ratio (OR) 2.66; 95% CI 1.64; 4.31; p < 0.001) versus endoscopic management. The latter was associated with higher rates of incomplete resection (OR 2.25; 95% CI 1.14, 4.46; p = 0.02) and further intervention (OR 1.78; 95% CI 1.09, 2.88; p = 0.02). There was no difference in the rates of late recurrence (OR 1.01; 95% CI 0.53, 1.91; p = 0.99) or further major surgery (OR 0.87; 95% CI 0.39, 1.94; p = 0.73) between the groups. Endoscopic treatment was associated with a shorter operating time (weighted mean difference (WMD) - 12.08; 95% CI - 18.97, - 5.19; p < 0.001) and LOS (WMD - 1.94; 95% CI - 2.43, - 1.44; p < 0.001), as well as lower rates of urinary retention post-operatively (OR 0.12; 95% CI 0.02, 0.63; p = 0.01). CONCLUSION: Endoscopic techniques should be favoured in the setting of benign early rectal neoplasms given their decreased morbidity and increased cost-effectiveness. However, where malignancy is suspected transanal surgery should be the preferred option given the superior R0 resection rate.

Concomitant vs. Staged Treatment of Varicose Tributaries as an Adjunct to Endovenous Ablation: A Systematic Review and Meta-Analysis.

OBJECTIVE: This review compares the outcomes of both concomitant and staged superficial varicose tributary (SVT) interventions as an adjunct to endovenous truncal ablation. METHODS: A systematic search of Medline through Pubmed, Embase, and the Cochrane Central Register of Controlled Trials was last performed in November 2019. All studies comparing the outcomes of both concomitant and staged treatments for SVT as an adjunct to endovenous truncal ablation were included. Each included study was subject to an evaluation of methodological quality using the Downs and Black assessment tool. Outcomes assessed included rates of re-intervention, complications, and thrombotic events. Quality of life (QOL) and disease severity were also analysed. Data were pooled with a random effects model. RESULTS: Fifteen studies (6 915 limbs) were included for analysis. Included studies were of reasonable methodological quality. Re-intervention rates were significantly lower in the concomitant group (6.3% vs. 36.1%) when compared with staged intervention (relative risk [RR] 0.21 [95% CI 0.07-0.62], p = .004, I2 = 90%, p ≤ .001). Reported complications (RR 1.14 [95% CI 0.67-1.93], p = .64) and rates of deep venous thrombosis (RR 1.41 [95% CI 0.72-2.77] p = .31) were similar in each group. Overall disease severity (Venous Clinical Severity Score) was lower in the concomitant group (-1.16 [95% CI, -1.97- -0.35] p = .005), while QOL, assessed using the Aberdeen Varicose Vein Questionnaire, favoured concomitant treatment when measured at less than three months (weighted mean difference [WMD] -3.6 [95% CI, -7.17- -0.03] p = .050) and between three and 12 months (WMD -1.61 [95% CI, -2.99- -0.23] p = .020). CONCLUSION: Concomitant and staged treatments are safe and effective. Improvements in early disease severity and QOL scores were better in the concomitant group. While meta-analysis suggests that concomitant intervention offers significantly lower rates of re-intervention, studies assessing its merits are subject to some biases. This benefit was not reflected by the randomised trial subgroup analysis, which identified no difference in re-intervention.

Does longitudinal or transverse orientation of the ultrasound probe improve cannulation success in minimally invasive venous surgery: A multicentre randomised controlled trial.

OBJECTIVE: This study evaluates the effect of transverse and longitudinal ultrasound transducer orientation on saphenous vein cannulation during endovenous ablation. METHODS: A single-blinded, multicentre, randomised controlled trial was performed in patients undergoing ultrasound-guided venous cannulation for saphenous ablation. The primary outcomes were overall cannulation success and time to successful cannulation. RESULTS: In total, 100 patients were assigned to parallel longitudinal orientation and transverse orientation groups. Cannulation success was 100%. There was no significant variation in time to cannulation detected between the transverse orientation and longitudinal orientation (85 s vs. 71 s, p = 0.314). Longitudinal orientation was associated with significantly fewer needle passes [median 3 (interquartile range 1-5) vs. 2 (interquartile range 1-3), p = 0.026] and less pain (median visual analogue scale score 1 vs. 2.5, p = 0.039) than those in the transverse orientation group. CONCLUSION: This trial has shown that while longitudinal orientation is associated with less procedural pain it has no significant effect on time to target vein cannulation during endovenous ablation.

A systematic review and meta-analysis of comparative studies comparing nonthermal versus thermal endovenous ablation in superficial venous incompetence.

OBJECTIVE: Endovenous thermal ablation (TA) offers an effective initial treatment option for superficial venous incompetence of the lower limb. These techniques offer lower complication rates with similar efficacy to traditional open surgery. In recent years, nonthermal ablation (NTA) in the form of mechanochemical ablation and cyanoacrylate vein ablation has been suggested to further reduce perioperative morbidity. This study aimed to compare the use of both thermal and nonthermal endovenous ablative techniques in the management of superficial venous incompetence. METHODS: A search of online databases including MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and Cochrane database was last performed in January 2019. Comparative studies comparing NTA with TA were included. The primary outcome was technical success. Secondary outcomes included operative pain, complications, modification of disease severity, and quality of life. RESULTS: Six studies describing the outcomes of 1236 participants and 1256 truncal ablations were included for analysis. Follow-up ranged from 6 weeks to 36 months. With regard to overall technical success, 458 of 483 (94.8%) receiving NTA and 521 of 553 (94.2%) undergoing TA had successful truncal ablation on follow-up ultrasound imaging at the study end point (pooled risk ratio, 1.01; 95% confidence interval [CI], 0.99-1.04). Subgroup analysis identified no difference in success between groups during immediate, 6-month, 12-month, or >12-month follow-up periods. Postprocedural pain was generally lower in those undergoing NTA with a mean difference of -18.11 (95% CI, -36.7 to 0.48). Techniques experienced significatly lower rates of ecchymosis (risk ratio, 0.43; 95% CI, 0.23-0.78), with no difference identified with regard to rates of paresthesia, phlebitis, and skin pigmentation. Further assessment of quality of life (mean difference, -0.27; 95% CI, -0.57 to 0.04) and Venous Clinical Severity Score (-0.52; 95% CI, -1.05 to 0.01) revealed no difference between groups. Included data were deemed of moderate methodologic quality. CONCLUSIONS: Nonthermal techniques are as effective as standard TA in the first year and, in some studies, may be associated with less procedural pain. These data suggest that NTA offers an alternative and safe means to treat superficial venous disease. There is, however, a need for further powered trials with larger numbers of patients and longer follow-up to definitively examine this hypothesis.

Supervised exercise therapy in the management of peripheral arterial disease - an assessment of compliance.

BACKGROUND: Supervised exercise therapy (SET) is an effective option in the management of peripheral arterial disease (PAD). Unfortunately, poor compliance remains prevalent. This study aimed to assess patient exercise compliance and to identify factors influencing symptomatic improvement and SET participation. PATIENTS AND METHODS: Data regarding attendance at SET for this cohort study were extracted from a prospectively maintained database of patients with claudication attending SET at Dublin City University. All patients had ankle brachial index confirmed PAD with associated intermittent claudication. Exercise performance and symptomatic data were gathered retrospectively using patient charts and interviews. RESULTS: Ninety-eight patients were referred for SET during the study period. The mean age was 69.2 (± 10.1) with 18 % being female. Median follow-up was 25.1 months (IQ range 17.0-31.6). Overall, the mean number of sessions attended per patient was 19.5. Exercise compliance was associated with a significant improvement in symptoms (p = 0.001). Other factors including anatomical level of claudication (P = 0.042) and educational level (p = 0.007) were found to affect the outcome of SET. Multivariate analysis revealed hypertension as a predictor of symptomatic outcome after SET (p = 0.045). Furthermore, ex-smokers (p = 0.021) and those previously diagnosed with hypercholesterolaemia (p = 0.020) or ischaemic heart disease (p = 0.029) had superior exercise compliance. Using linear regression, smoking history (p = 0.024) was identified as a predictor of compliance to SET. CONCLUSIONS: Establishing exercise compliance remains challenging in the PAD cohort. Pre-exercise patient education and personalised exercise prescriptions may result in improvements in function and compliance.