Systematic Review on Botulinum Toxin Injections as Diagnostic or Therapeutic Tool in Thoracic Outlet Syndrome.

BACKGROUND: The optimal diagnostic and treatment algorithm for patients with suspected thoracic outlet syndrome (TOS) remains challenging. Botulinum toxin (BTX) muscle injections have been suggested to shrink muscles in the thoracic outlet reducing neurovascular compression. This systematic review evaluates the diagnostic and therapeutic value of BTX injections in TOS. METHODS: A systematic review of studies reporting BTX as a diagnostic or therapeutic tool in TOS (or pectoralis minor syndrome as TOS subtype) was conducted in PubMed, Embase, and CENTRAL databases on May 26, 2022. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement was followed. Primary end point was symptom reduction after primary procedure. Secondary end points were symptom reduction after repeated procedures, the degree of symptom reduction, complications, and duration of clinical effect. RESULTS: Eight studies (1 randomized controlled trial [RCT], 1 prospective cohort study, and 6 retrospective cohort studies) were included reporting 716 procedures in at least 497 patients (at minimum 350 primary and 25 repeated procedures, residual unclear) diagnosed with presumably only neurogenic TOS. Except for the RCT, the methodological quality was fair to poor. All studies were designed on an intention to treat basis, one also investigated BTX as a diagnostic tool to differentiate pectoralis minor syndrome from costoclavicular compression. Reduction of symptoms was reported in 46-63% of primary procedures; no significant difference was found in the RCT. The effect of repeated procedures could not be determined. Degree of symptom reduction was reported by up to 30-42% on the Short-form McGill Pain scale and up to 40 mm on a visual analog scale. Complication rates varied among studies, no major complications were reported. Symptom relief ranged from 1 to 6 months. CONCLUSIONS: Based on limited quality evidence, BTX may provide short-lasting symptom relief in some neurogenic TOS patients but remains overall undecided. The role of BTX for treatment of vascular TOS and as a diagnostic tool in TOS is currently unexploited.

The upper extremity postthrombotic syndrome score: an international Delphi consensus study to determine the score's functional disability component.

Background: In upper extremity thrombosis research, the occurrence of upper extremity postthrombotic syndrome (UE-PTS) is commonly used as the main outcome parameter. However, there is currently no reporting standard or a validated method to assess UE-PTS presence and severity. In a recent Delphi study, consensus was reached on a preliminary UE-PTS score, combining 5 symptoms, 3 signs, and the inclusion of a functional disability score. However, no consensus was reached on which functional disability score to be included. Objectives: The aim of the current Delphi consensus study was to determine the specific type of functional disability score to finalize UE-PTS score. Methods: This Delphi project was designed as a three-round study using open text questions, statements with 7-point Likert scales, and multiple-choice questions. The CREDES recommendations for Delphi studies were applied. In this context, a systematic review was conducted before the start of the Delphi rounds to identify the available functional disability scores as available in the literature and present these to the expert panel. Results: Thirty-five of 47 initially invited international experts from multiple disciplines completed all the Delphi rounds. In the second round, consensus was reached on the incorporation of the quick disabilities of the arm, shoulder, and hand (QuickDASH) in the UE-PTS score, rendering the third round obsolete. Conclusion: Consensus was reached that the QuickDASH should be incorporated in the UE-PTS score. The UE-PTS score will need to be validated in a large cohort of patients with upper extremity thrombosis before it can be used in clinical practice and future research.

Thoracic outlet syndrome (TROTS) registry: A study protocol for the primary upper extremity deep venous thrombosis section.

INTRODUCTION: There is a lack of comprehensive and uniform data on primary upper extremity deep venous thrombosis (pUEDVT). pUEDVT includes venous thoracic outlet syndrome related upper extremity deep venous thrombosis (UEDVT) and idiopathic UEDVT. Research on these conditions has been hampered by their rarity, lack of uniform diagnostic criteria, and heterogeneity in therapeutic strategies. To improve current research data collection using input of all various pUEDVT treating medical specialists, we initiated the ThoRacic OuTlet Syndrome (TROTS) registry. The aim of the TROTS registry is to a) collect extensive data on all pUEDVT patients through a predefined protocol, b) give insight in the long term outcome using patient reported outcome measures, c) create guidance in the diagnostic and clinical management of these conditions, and thereby d) help provide content for future research. METHODS AND ANALYSIS: The TROTS registry was designed as an international prospective longitudinal observational registry for data collection on pUEDVT patients. All pUEDVT patients, regardless of treatment received, can be included in the registry after informed consent is obtained. All relevant data regarding the initial presentation, diagnostics, treatment, and follow-up will be collected prospectively in an electronic case report form. In addition, a survey containing general questions, a Health-related Quality of Life questionnaire (EQ-5D-5L), and Functional Disability questionnaire (Quick-DASH) will be sent periodically (at the time of inclusion, one and two years after inclusion, and every five years after inclusion) to the participant. The registry protocol was approved by the Medical Ethical Review Board and registered in the Netherlands Trial Register under Trial-ID NL9680. The data generated by the registry will be used for future research on pUEDVT and published in peer reviewed journals. CONCLUSION: TROTS registry data will be used to further establish the optimal management of pUEDVT and lay the foundation for future research and guidelines.

Multicenter Case Series and Literature Review on Durability of Stents in the Thoracic Outlet.

PURPOSE: The aim of this paper was to report our experience with arterial and venous endovascular stent placement in the thoracic outlet (TO) and review available literature. METHODS: All patients that underwent arterial or venous stent placement in the TO between 2013 and 2020 in 5 Dutch vascular teaching-hospitals were retrospectively identified. Primary endpoint was symptomatic stent failure due to stenosis, chronic or posture dependent compression, fracture, or occlusion of the stent. Secondary endpoints were symptoms at last follow-up and re-interventions. For the literature review, we searched studies reporting on stenting in the TO. RESULTS: Twenty-six patients were included with 11 arterial and 15 venous stents implanted to treat angioplasty resistant stenosis in arterial or venous TO syndrome, iatrogenic or traumatic vascular injury, radiotherapy fibrosis, or arterial dissection. Median follow-up was 19 and 14 months in the arterial and venous-group, respectively. Eight (73%) patients in the arterial, and 9 (60%) in the venous-group suffered symptomatic stent failure. Seven (64%) patients in the arterial, and 9 (60%) in the venous-group required at least 1 re-intervention. When comparing all patients with stent placement after TO decompression (TOD) to patients without, there were substantially more symptomatic stent failures and re-interventions required in the patients without TOD. Six patients (54%) in the arterial-group and 11 (73%) in the venous-group were symptom-free at last follow-up. Five articles describing 51 patients with arterial and 6 articles describing 81 patients with venous stents were included in the literature review. In the arterial-group, no TOD prior to stent placement was performed, while in the venous-group all but 1 article performed TOD prior to stent placement. Results showed comparable rates of symptomatic stent failure (24% vs 30%), and patients requiring re-interventions (29% vs 21%) between groups. CONCLUSION: Based on our multicenter series and review, stents in the TO have a considerable risk of failure, both in the venous and the arterial territory. Especially in patients without TOD: the need for re-interventions is high and half the patients eventually undergo TOD. Based on the currently available data, stenting in the TO should be applied cautiously while TOD should be considered.

Editor's Choice - Risk of Bleeding Complications With Different Peri-Operative Antithrombotic Regimens During Carotid Endarterectomy: a National Registry Analysis.

OBJECTIVE: Antithrombotic therapy is one of the cornerstones of the prevention of (recurrent) ocular or cerebral ischaemic events in patients with carotid artery stenosis. Randomised controlled trials on antithrombotic therapy for patients with minor ischaemic stroke and transient ischaemic attack (TIA) have recommended dual antiplatelet therapy (DAPT) in the three weeks following the index event. However, these trials excluded patients undergoing carotid revascularisation. To date, the optimal antithrombotic therapy during the peri-operative period of carotid endarterectomy (CEA) remains unclear. METHODS: Symptomatic and asymptomatic patients with carotid artery stenosis undergoing primary CEA from the Dutch Audit for Carotid Interventions registry between June 2013 and December 2020 were eligible for inclusion. The primary outcome was defined as post-operative cervical bleeding needing re-intervention or intracranial haemorrhage during the first 30 days following CEA. The secondary outcomes were ischaemic stroke or TIA or all cause mortality during the first 30 days following CEA. Descriptive statistics and multiple logistic regressions analyses were applied, with acetylsalicylic acid (ASA) as the reference value. RESULTS: A total of 12 317 patients were included. In the peri-operative phase, 31.0% of patients were treated with ASA, 32.4% with clopidogrel, 11.1% with ASA plus clopidogrel, 10.4% with ASA plus dipyridamole, 10.3% with vitamin K antagonist, and 4.8% with direct acting oral anticoagulants therapy. After multiple logistic regression analysis, no association was seen with the primary outcome in ASA plus clopidogrel (odds ratio [OR] 0.81; confidence interval [CI] 0.58 - 1.13; p = .23), and ASA plus dipyridamole (OR 0.69; CI 0.47 - 1.00; p = .059). Both the DAPT therapies were not associated with the secondary outcome. CONCLUSION: The effectiveness and safety of DAPT did not differ from single antiplatelet therapy (SAPT) in patients undergoing CEA and further evaluation is needed in prospective studies. Considering additional data from the literature and guideline recommendations, DAPT should be started immediately after stroke until 30 days after CEA followed by SAPT, due to a possible reduction in the risk of recurrence.

Post-thrombotic syndrome after upper extremity deep vein thrombosis: An international Delphi consensus study.

OBJECTIVES: Primary deep vein thrombosis of the upper extremity (UEDVT) is a rare condition but up to 60% of patients may develop post-thrombotic syndrome in the upper extremity (UE-PTS) with significant morbidity and decreased quality of life. However, there is no universally accepted method to diagnose and classify UE-PTS, hampering scientific research on UEDVT treatment. Through this international Delphi consensus study we aimed to determine what a clinical score for diagnosing UE-PTS should entail. METHODS: An online focus group survey among 20 patients treated for UEDVT was performed to provide clinical parameters before the start of a four round electronic Delphi consensus study among 25 international experts. The CREDES recommendations on Conducting and Reporting Delphi Studies were applied. Open text questions, multiple selection questions, and 9-point Likert scales were used. Consensus was set at 70% agreement. RESULTS: After four rounds, agreement was reached on a composite score of five symptoms and three clinical signs, combined with a functional disability score. The signs and symptom will each be scored on a severity scale of 0-3 and the total score expressed as an ordinal variable; no/mild/moderate/or severe PTS. The functional disability portion measures the impact of the signs and symptoms on the functionality of the patient's arm. CONCLUSION: Consensus was reached on a composite score of signs and symptoms of UE-PTS combined with a functional disability score. Clinical validation of the UE-PTS score in a large patient cohort is mandatory to facilitate application in future research.

Functional outcome of arterial thoracic outlet syndrome treatment.

Introduction: The low prevalence of Arterial Thoracic Outlet Syndrome (ATOS) and diffuse symptomatology have resulted in limited data on optimal treatment strategies and long-term outcome. The aim of this study was to report and evaluate a single center experience with the treatment of ATOS including midterm patient reported outcome. Methods: All patients treated for ATOS from 2004 to 2020 were retrospectively identified. Patients were divided into two groups based on presenting symptoms; ATOX group (Acute arterial occlusion with ischemia) and ATOS group (claudication symptoms). Baseline characteristics and treatment details were extracted from electronic patient files. A telephone survey was conducted to collect patients' follow-up data including a functional disability score using the Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The primary endpoint of this study was symptom-free survival. Secondary endpoints were median QuickDASH scores during follow-up, postoperative complications and possible re-interventions. Results: A total of 20 patients (mean age 44.6 years, median follow-up 50.5 months) were included and divided into two groups (ATOX N = 9, ATOS N = 11). In the ATOX group, eight patients were primarily treated with catheter directed thrombolysis (CDT; N = 5) or surgical thrombectomy (N = 3). All patients received staged thoracic outlet decompression surgery (TOD). In the ATOS group, 10 patients primarily received TOD and one patient was treated conservatively with physiotherapy. Seven ATOX patients and nine ATOS patients were symptom free at follow-up with a median QuickDASH score of 2.3 (IQR 12.5) and 2.3 (IQR 16.5) respectively. Ten complications occurred in the ATOX group; three bleeding complications, five re-occlusions, one arterial dissection and one occipital infarction. In the ATOS group five complications occurred; one perioperative bleeding complication, three re-occlusions and a stent fracture. Seven vs. five re-interventions were required in the ATOX and ATOS groups respectively. Conclusion: The mid-term self-reported symptom free survival in both the ATOX as well as ATOS group seems acceptable while median QuickDASH scores in both groups indicate a very good functional outcome. This however comes at the cost of treatment related bleeding complications in especially the ATOX group presumably due to thrombolysis, and re-interventions required in almost one out of three patients.

Variation in perioperative cerebral and hemodynamic monitoring during carotid endarterectomy.

BACKGROUND: Hemodynamic disturbances cause half of the perioperative strokes following carotid endarterectomy (CEA). Guidelines strongly recommend strict pre- and postoperative blood pressure (BP) monitoring in CEA patients, but do not provide firm practical recommendations. Although in the Netherlands 50 centres perform CEA, no national protocol on perioperative hemodynamic, and cerebral monitoring exists. To assess current monitoring policies of all Dutch CEA-centres, a national survey was conducted. METHODS: Between May and July 2017 all 50 Dutch CEA-centres were invited to complete a 42-question survey addressing perioperative hemodynamic and cerebral monitoring during CEA. Nonresponders received a reminder after 1 and 2 months. By November 2017 the survey was completed by all centres. RESULTS: Preoperative baseline BP was based on a single bilateral BP-measurement at the outpatient-clinic in the majority of centres (n = 28). In 43 centres (86%) pre-operative monitoring (transcranial Doppler (TCD, n = 6), electroencephalography (EEG, n = 11), or TCD + EEG (n = 26)) was performed as a baseline reference. Intraoperatively, large diversity for type of anaesthesia (general: 45 vs. local [LA]:5) and target systolic BP (>100 mm hg - 160 mm hg [n = 12], based on preoperative outpatient-clinic or admission BP [n = 18], other [n = 20]) was reported. Intraoperative cerebral monitoring included EEG + TCD (n = 28), EEG alone (n = 13), clinical neurological examination with LA (n = 5), near-infrared spectroscopy with stump pressure (n = 1), and none due to standard shunting (n = 3). Postoperatively, significant variation was reported in standard duration of admission at a recovery or high-care unit (range 3-48 hr, mean:12 hr), maximum accepted systolic BP (range >100 mm hg - 180 mm Hg [n = 32]), postoperative cerebral monitoring (standard TCD [n = 16], TCD on indication [n = 5] or none [n = 24]) and in timing of postoperative cerebral monitoring (range directly postoperative - 24 hr postoperative; median 3 hr). CONCLUSIONS: In Dutch centres performing CEA the perioperative hemodynamic and cerebral monitoring policies are widely diverse. Diverse policies may theoretically lead to over- or under treatment. The results of this national audit may serve as the baseline dataset for development of a standardized and detailed (inter)national protocol on perioperative hemodynamic and cerebral monitoring during CEA.

Protocol for a prospective, longitudinal cohort study on the effect of arterial disease level on the outcomes of supervised exercise in intermittent claudication: the ELECT Registry.

INTRODUCTION: Despite guideline recommendations advocating conservative management before invasive treatment in intermittent claudication, early revascularisation remains widespread in patients with favourable anatomy. The aim of the Effect of Disease Level on Outcomes of Supervised Exercise in Intermittent Claudication Registry is to determine the effect of the location of stenosis on the outcomes of supervised exercise in patients with intermittent claudication due to peripheral arterial disease. METHODS AND ANALYSIS: This multicentre prospective cohort study aims to enrol 320 patients in 10 vascular centres across the Netherlands. All patients diagnosed with intermittent claudication (peripheral arterial disease: Fontaine II/Rutherford 1-3), who are considered candidates for supervised exercise therapy by their own physicians are appropriate to participate. Participants will receive standard care, meaning supervised exercise therapy first, with endovascular or open revascularisation in case of insufficient effect (at the discretion of patient and vascular surgeon). For the primary objectives, patients are grouped according to anatomical characteristics of disease (aortoiliac, femoropopliteal or multilevel disease) as apparent on the preferred imaging modality in the participating centre (either duplex, CT angiography or magnetic resonance angiography). Changes in walking performance (treadmill tests, 6 min walk test) and quality of life (QoL; Vascular QoL Questionnaire-6, WHO QoL Questionnaire-Bref) will be compared between groups, after multivariate adjustment for possible confounders. Freedom from revascularisation and major adverse cardiovascular disease events, and attainment of the treatment goal between anatomical groups will be compared using Kaplan-Meier survival curves. ETHICS AND DISSEMINATION: This study has been exempted from formal medical ethical approval by the Medical Research Ethics Committees United 'MEC-U' (W17.071). Results are intended for publication in peer-reviewed journals and for presentation to stakeholders nationally and internationally. TRIAL REGISTRATION NUMBER: NTR7332; Pre-results.

[Faster wound healing after vascular surgery: negative pressure wound therapy for exposed prosthetic vascular grafts in the groin]. / Snellere wondgenezing na vaatchirurgie.

Vascular surgery in the groin is highly susceptible to wound infection (up to about 30%). Wound infections associated with exposed vascular prosthetic grafts are difficult to treat and may lead to acute bleeding or graft failure, requiring amputation of the lower limb in extreme cases. Negative pressure wound therapy is a method to promote wound healing in case of infected vascular grafts. Since there is suspected risk of bleeding, this technique has been adapted with a double-sponge technique in combination with lower negative pressure.

Long-term risk of vascular events after peripheral bypass surgery. A cohort study.

Patients with peripheral arterial disease (PAD) are at high risk of major ischaemic events. Long-term data of all major ischaemic events in PAD patients are scarce and outdated, especially for patients with severe PAD requiring bypass surgery. Our objective was to define their long-term prognosis and develop a prediction model which quantifies this risk up to a decade after surgery. We conducted a retrospective cohort study in patients from the Dutch Bypass Oral anticoagulants or Aspirin (BOA) Study; a multicentre randomised trial comparing oral anticoagulants with aspirin after infrainguinal bypass surgery. The primary outcome was the composite event of non-fatal myocardial infarction, non-fatal ischaemic stroke, major amputation, and vascular death. Cumulative risks were assessed by Kaplan-Meier analysis and independent determinants by multivariable Cox regression models. From 1995 until 2009, 482 patients were followed for a median period of 7.8 years. Follow-up was complete in 94%. Overall 60% of patients experienced a primary outcome event, of which the majority was a vascular death (30%), followed by major amputations (12%). The primary cause of vascular death was a cardiovascular event (29%), whereas the minority was due to complications directly related to PAD (6%). Within five years after bypass surgery vascular death occurred in about a quarter of patients and within 10 years in nearly half of patients. This was double the rate as for non-vascular death. The primary outcome event occurred in over a third and over half of patients in 5 and 10 years after bypass surgery, respectively. From four independent determinants for the primary outcome event: age, diabetes, critical limb ischaemia, and prior vascular interventions, we developed a risk chart, which systematically classifies the 10-year risks of the primary outcome event, ranging from 25% to 85%. This study provided a detailed insight in the course of PAD long after peripheral bypass surgery and enables individual risk assessment of major fatal and non-fatal ischaemic events by means of cumulative incidences and a risk chart.

The quality of life in patients after peripheral bypass surgery deteriorates at long-term follow-up.

OBJECTIVE: We aimed to study the long-term development of health-related quality of life (HR-QoL) in patients with peripheral arterial disease after they underwent peripheral bypass surgery and to evaluate the influence of adverse vascular events that occurred during follow-up. METHODS: We compared current HR-QoL scores with previous measurements in patients who participated in the Dutch Bypass and Oral Anticoagulants or Aspirin (BOA) Study between 1995 and 1998 after they underwent infrainguinal bypass surgery. Patients from six centers that contributed most to the Dutch BOA Study (n = 482) were followed up retrospectively from 1995 up to 2009. RESULTS: At a mean follow-up of 11 years since BOA randomization, 165 of the 482 patients were alive of whom 123 (75%) completed the EQ-5D and RAND-36 questionnaires. Fifty-three patients completed the questionnaires three times: at BOA entry, at BOA close-out, and at BOA long-term follow-up. In these patients the HR-QoL scores decreased over time, especially for the physical health dimension. In comparison with the general population, matched for age and gender, the HR-QoL scores at both BOA entry and long-term follow-up were substantially lower, even if the patient's graft was patent and no other vascular events had occurred. The occurrence of an adverse vascular event worsened the physical health state further. CONCLUSIONS: The physical HR-QoL in patients with peripheral arterial disease (PAD) after peripheral bypass surgery was highly impaired, independent of graft patency, and deteriorated further over time. An adverse vascular event worsened the physical health state and underlined the importance of atherosclerotic risk management as well as stimulation of physical activity in patients with peripheral arterial disease to preserve HR-QoL.

Bleeding increases the risk of ischemic events in patients with peripheral arterial disease.

BACKGROUND: Patients with peripheral arterial disease are at high risk of ischemic events and therefore are treated with antithrombotics. In patients with coronary artery disease or cerebrovascular disease, bleeding is related to the subsequent occurrence of ischemic events. Our objective was to assess whether this is also the case in patients with peripheral arterial disease. METHODS AND RESULTS: All patients from the Dutch Bypass and Oral Anticoagulants or Aspirin (BOA) Study, a multicenter randomized trial comparing oral anticoagulants with aspirin after infrainguinal bypass surgery, were included. The primary outcome event was the composite of nonfatal myocardial infarction, nonfatal ischemic stroke, major amputation, and cardiovascular death. To identify major bleeding as an independent predictor for ischemic events, crude and adjusted hazard ratios with 95% confidence intervals were calculated with multivariable Cox regression models. From 1995 until 1998, 2650 patients were included with 101 nonfatal major bleedings. During a mean follow-up of 14 months, the primary outcome event occurred in 218 patients; 22 events were preceded by a major bleeding. The mean time between major bleeding and the primary outcome event was 4 months. Major bleeding was associated with a 3-fold increased risk of subsequent ischemic events (crude hazard ratio, 3.0; 95% confidence interval, 1.9 to 4.6; adjusted hazard ratio, 3.0; 95% confidence interval, 1.9 to 4.7). CONCLUSIONS: In patients with peripheral arterial disease, as in patients with coronary artery disease or cerebrovascular disease, major bleeding was independently associated with major ischemic complications. Without compromising the benefits of antithrombotics, these findings call for caution relative to the risks of major bleeding.

Angioplasty with or without stent placement in the brachiocephalic artery: feasible and durable? A retrospective cohort study.

PURPOSE: To evaluate the results of percutaneous transluminal angioplasty (PTA) and stent placement in isolated brachiocephalic trunk lesions. MATERIALS AND METHODS: PTA, with or without stent placement, was used to treat 30 patients with isolated clinically significant stenoses (n = 25) or occlusions (n = 5) of the brachiocephalic artery. Initial clinical success was defined as a relief or substantial reduction of the preprocedural symptoms, and initial technical success was defined as a mean translesion pressure gradient of less than 5 mm Hg or a residual stenosis of less than 20%. Clinical evaluation and duplex Doppler ultrasonography of the lesion site were performed at follow-up. Clinical restenosis was defined as recurrent clinical symptoms and a lumen reduction of more than 50%, determining the primary clinical patency. Technical restenosis was defined as more than 50% lumen reduction with or without renewed clinical symptoms, determining the primary technical patency. RESULTS: The initial technical success rate was 83% (occlusions, 60%; stenoses, 88%), and the clinical success rate was 81%. Two patients had major complications, and four experienced minor complications. At a median follow-up of 24 months (4 weeks to 92 months), the primary clinical patency rate was 79% (95% confidence interval [CI]: 57%, 104%), with 83% (95% CI: 60%, 105%) for arteries with stents and 67% (95% CI: 13%, 120%) for those without stents (P = .11). The primary technical patency rate was 50% (95% CI: 24%, 76%). CONCLUSION: PTA with or without stent placement in a stenotic or occlusive brachiocephalic artery is a procedure of tolerable safety with a high initial success rate; however, only moderately rewarding results were obtained after 2 years. Selective stent placement probably improves long-term success. Primary PTA with selective stent placement in an atherosclerotic obstructive brachiocephalic artery should be considered the preferred treatment option.