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.

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.

Comparison of Photo-optical Transcutaneous Oxygen Tension Measurement with Electro-chemical Transcutaneous Oxygen Tension Measurement in Patients with Arterial Claudication.

PURPOSE: Photo-optical TCpO2 (pTCpO2) has been proposed as a new method to determine the partial oxygen pressure of the lower extremity in patients with peripheral arterial disease. It is aimed to determine the level of agreement between pTCpO2 and the traditional electro-chemical transcutaneous oxygen tension measurement (eTCpO2). METHODS: Eighteen patients with intermittent claudication underwent simultaneous ankle-brachial index measurement, toe-pressure, pTCpO2 and eTCpO2 tests. Oxygen tension levels were measured on anterior chest and calf prior in rest (T0), during induced ischemia (T1) and after blood flow restoration (T2). TCpO2 agreement was assessed according to the principles of Bland and Altman. RESULTS: Absolute average TCpO2 values differed between eTCpO2 and pTCpO2 for calf in T2 (38,1 mmHg (σ 14,4) vs. 49,8 (σ 22.3) with P = 0.35). The Bland-Altman plots demonstrated eTCpO2 and pTCpO2 bias of 3,7 mmHg (σ 18,8), 11,6 mmHg (σ 17,6) and 6,7 mmHg (σ 23,5) for T0, T1 and T2 for the calf. CONCLUSION: pTCpO2 is in agreement with eTCpO2 in measuring pO2 levels of the lower extremity in rest and during induced ischemia in patients with vascular claudication. The large variability between eTCpO2 and pTCpO2 should be accounted for, while pTCpO2 values have a tendency to demonstrate higher values in comparison to eTCpO2.

Photo-Optical Transcutaneous Oxygen Tension Measurement Is of Added Value to Predict Diabetic Foot Ulcer Healing: An Observational Study.

Currently, transcutaneous oxygen tension measurement (TCpO2) is the most favorable non-invasive test for diabetic foot ulcer (DFU) healing prognosis. Photo-optical TCpO2 is novel, less time-consuming and more practical in use compared to regular electro-chemical TCpO2. We prospectively investigated the clinical value of photo-optical TCpO2 to predict DFU healing. Patients with suspected DFU undergoing conservative treatment underwent an ankle pressure, toe-pressure and photo-optical TCpO2 test. The primary endpoint was DFU wound healing at 12 months. Based on their clinical outcome, patients were divided into a DFU healing and DFU non-healing group. Healing was defined as fully healed ulcers and non-healing as ulcers that deteriorated under conservative treatment or that required surgical amputation. Differences between groups were analyzed and an optimal TCpO2 cut-off value was determined. In total, 103 patients were included, of which 68 patients (66%) were classified as DFU healing. The remaining 35 patients (34%) had deteriorated ulcers, of which 29 (83%) eventually required surgical amputation. An optimal TCpO2 cut-off value of 43 mmHg provided a sensitivity, specificity and odds ratio of 0.78, 0.56 and 4.4, respectively. Photo-optical TCpO2 is an adequate alternative tool to validate the vascular status of the lower extremity indicating healing prognosis in patients with DFU. Therefore, we recommend that photo-optical TCpO2 can be safely coapplied in clinical practice to assist in DFU treatment strategy.

Timing of Thoracic Outlet Decompression after Thrombolysis for Primary Upper Extremity Deep Venous Thrombosis: A Systematic Review.

BACKGROUND: The optimal timing of decompression surgery after thrombolysis in patients with primary upper extremity deep vein thrombosis (UEDVT) is still a matter of debate. This systematic review compares the safety and efficacy of early intervention versus postponed intervention in patients with primary UEDVT. METHODS: A structured PUBMED, EMBASE, and COCHRANE search was performed for studies reporting on the timing of surgical intervention for primary UEDVT. Studies reporting on timing of decompression surgery in combination with recurrent thrombosis, bleeding complications, and symptom-free survival were included. Two treatment groups were defined; group A received surgical decompression within two weeks after thrombolysis and group B after two weeks or more. All end points were assessed in accordance with the reported outcomes in the included articles. Mean percentages were calculated using descriptive statistics. RESULTS: Six articles (126 patients) were included: 87 patients in group A versus 39 in group B. In group A, bleeding complications occurred in 7% of patients versus 5% in group B. Two-third of the bleeding complications in group A occurred in patients receiving surgical decompression within 24 hr after thrombolysis while kept on intravenous heparin both preoperatively and postoperatively. Reported preoperative recurrent thrombosis was 7% in group A versus 11% in group B, another 13% had postoperative recurrent thrombosis versus 21% in group B. The effectiveness of both treatment strategies was comparable with a total of 89% of patients in group A with minimal or no symptoms at final follow-up compared with 90% in group B. The mean follow-up in group A was 35 months (1-168 months) and 28 months (1-168 months) in group B. CONCLUSIONS: Based on the limited available data presented in this review, early decompression surgery within two weeks after catheter-directed thrombolysis seems as safe and effective as postponed surgical intervention in patients with primary UEDVT.