OBJECTIVE:The endovascular treatment of venous obstruction has expanded significantly in recent years. Best practices for optimal patient outcomes are not well established and the evidence base is poor. The purpose of this study was to obtain consensus on management criteria for patients with lower extremity venous outflow obstruction.METHODS:The study was conducted as a two round Delphi consensus. Statements addressed imaging, symptoms and other baseline measures, differential diagnosis, treatment algorithm, indications for stenting, inflow and outflow assessment, successful procedural outcomes, post-procedure therapies and stent surveillance, and clinical success factors. Statements were prepared by six expert physicians (round 1, 40 statements) and an expanded panel of 24 physicians (round 2, 80 statements) and sent to a pre-identified group of venous experts who met qualifying criteria. A 9 point Likert scale was used and consensus was defined as ≥ 70% of respondents rating a statement between 7 and 9 (agreement) or between 1 and 3 (disagreement). Round 1 results were used to guide rewording and splitting compound statements for greater clarity in round 2.RESULTS:In round 1, 75 of 110 (68%) experts responded, and 91 of 121 (75%) experts responded in round 2. Round 1 achieved consensus in 32/40 (80%) statements. Consensus was not reached in the treatment algorithm section. Round 2 achieved consensus in 50/80 (62.5%). Statements reaching consensus were imaging (2/3, 66%), symptoms and other baseline measures (12/24, 50%), differential diagnosis (2/8, 25%), treatment algorithm (10/17, 59%), indications for stenting (10/10, 100%), inflow and outflow assessment (2/2, 100%), procedural outcomes (2/2, 100%), post-procedure therapies and stent surveillance, (5/7, 71%), and clinical success factors (5/7, 71%).CONCLUSION:This study demonstrated that considerable consensus was achieved between venous experts on the optimal management of lower extremity venous outflow obstruction. There were multiple domains where consensus is lacking, highlighting important areas for further investigation and research.
The endovascular treatment of venous obstructive disease has expanded significantly in recent years. However, best practices for optimal patient outcomes are not well established outside of the expert community and the evidence base is poor. The purpose of this study was to determine the level of consensus on statements regarding best practices. The study was conducted as a two round Delphi consensus. Statements for the first round were prepared by six expert physicians (round 1) and an expanded panel of 24 physicians (round 2) and sent to a preidentified group of venous experts who met qualifying criteria for each round. The statements were based on clinical scenarios covering the areas of imaging, clinical symptoms and baseline measures, differential diagnosis, treatment algorithm, indications for stenting, inflow/outflow assessment, successful procedural outcomes, postprocedure care and follow-up, and successful clinical outcomes. There were 39 and 80 statements in rounds 1 and 2, respectively. Respondent agreement was assessed using a 9-point Likert scale (agreed to disagreed) and a “cannot assess” option were used for each question. Consensus was defined as 70% respondents rating a statement 7 to 9 (signifying agreement) or 1 and 3 (signifying disagreement). The results of the first round were used to guide rewording and splitting compound statements for the greater clarity for the second round. The first round survey received a 68% response rate (75/110), and the second round received a 75% response rate (91/121). Respondents identified themselves as vascular surgeons (52.8%), interventional radiologists (33.0%), interventional cardiologists (8.8%), and other (5.5%) and represented the Americas (73.6%), Europe/Middle East (18.7%), and Asia Pacific (7.7%). Round 1 achieved consensus in 32/39 (82%) statements. Consensus was not reached in the treatment algorithm section. Round 2 achieved consensus in 50/80 (62.5%). The number of statements reaching consensus in the following areas were as follows: imaging (2/3 [66%]), clinical symptoms and baseline measures (12/24 [50%]), differential diagnosis (2/8 [25%]), treatment algorithm (10/17 [59%]), indications for stenting (10/10 [100%]), inflow/outflow assessment (2/2 [100%]), procedural outcomes (2/2 [100%]), postprocedure care (5/7 [71%]), and successful clinical outcomes (5/7 [71%]). This study demonstrated that while there are several areas where venous experts agree on the assessment and management of venous outflow obstruction, there are multiple domains where consensus was not achieved. This underlines that treating venous disease remains a controversial area and requires focused and coordinated research efforts across specialties to answer a number of unresolved clinical questions. The Delphi consensus has identified those areas in which these efforts should be focused.
A 22-year-old college student presented with complaints of left calf cramping with exertion. She otherwise had no systemic symptoms and denied angina, dyspnea on exertion, syncope, or leg swelling. Her medical history included osteochondroma, for which she had undergone numerous surgeries (owing to increased pain and size). Left posterior tibial and dorsalis pedis pulses were absent (2+ on the right lower extremity). Her left lower extremity ankle–brachial index (ABI) was 0.78 (right side was normal). Multiple views of a computed tomography angiography (CTA) illustrated the following: a 9.8-cm prominent osteochondroma in the left distal femur causing a 3.8-cm occlusion of the distal left superficial femoral artery; a widely patent right superficial femoral artery; a small osteochondroma within the right distal femur (Panel A, arrow); occlusion of the left superficial femoral artery from a protruding osteochondroma that projects from the left femur (Panel B, arrow). A widely patent and normal caliber abdominal aorta without stenosis or dissection (Panel C). After a multidisciplinary discussion with vascular medicine, vascular surgery, and orthopedics, it was decided to utilize conservative treatment with cilostazol and a walking program. It was felt that an extra-anatomic bypass in a young patient should be reserved for ischemic rest pain or ischemic complications, as collaterals would become more robust over time. Osteochondromas are the most common benign bone tumors – with the majority of cases developing during
We read with great interest the study of Weinberg and colleagues, a duplex ultrasound subgroup analysis of the ATTRACT trial, which for the first time allows for evaluation of the technical procedural success of the study.1,2 The underlying aim of the ATTRACT trial was to test the open vein hypothesis of deep vein thrombosis (DVT) by early thrombus removal with pharmacomechanical catheterdirected thrombolysis (PCDT), as previous published data had not enabled a clear evaluation and understanding of the efficacy of thrombus removal. The authors report that at 1 month, the PCDT arm had less residual thrombus than the control arm: common femoral vein (CFV) (21% PCDT vs 35% control, p < 0.0001), femoral vein (51% PCDT vs 70% control, p < 0.0001), and popliteal vein (61% PCDT vs 74% control, p < 0.0001).1 Baseline noncompressibility of the CFV was 31/58 (53%) compared with only 21% at 1 month (12/58). It is unclear why the technical success rate of PCDT for CFV thrombus in this substudy was so low (19/31; 61%). In comparison, a separate study of 191 consecutive patients with acute iliofemoral DVT treated with catheter-directed thrombolysis reported duplex ultrasound patency results of > 90% at 1 month.3 In the ultrasound substudy, technical success was even lower among patients undergoing PCDT in the femoropopliteal group at 1 month: femoral vein and popliteal vein 23/53 (43%) and 13/48 (27%), respectively.1 These results make it difficult to prove the open vein hypothesis when residual thrombus was present in nearly 40% of those with treated iliofemoral DVT and up to 70% of those in the popliteal segment, which has previously been associated with long-term procedural success.3 The importance of successful early thrombus removal was reinforced by results in Supplemental Table S3, which reported that restoration of CFV compressibility at 1 month was associated with significant reduction in the development of PTS (p = 0.004). Weinberg and colleagues report that venous valvular reflux appears to play a role in progression to moderate-orsevere PTS.1 A threshold of 0.5 s was selected to avoid missing instances of reflux; however, it has been demonstrated that a cut-off of > 1 s for femoropopliteal veins better represents patients with venous disease.4 At 12 months, the proportion of patients with reflux in any vein (85% PCDT vs 91% control, p = 0.35) were similar in both groups. Therefore, the authors conclude that PCDT does not reduce venous valvular reflux. As the technical success of PCDT was low, significant residual thrombus was present in treated iliofemoral and femoropopliteal vein segments, and only 18% of the total study population had ultrasound follow-up at 12 months, we find it difficult to understand how the authors justify this conclusion. In our assessment, the ATTRACT trial has set a foundation for how future studies on the treatment of acute iliofemoral DVT should be modified to truly address the open vein hypothesis. The heterogeneity of data from trials of endovenous thrombolysis makes even meta-analysis of these outcomes difficult, though it is clear that clinical results are predicated upon successful thrombus removal – as this study again demonstrates.5 The importance of technical procedural success in these studies cannot be overstated – low procedural success leads to a closed vein and worse patient outcomes.
OBJECTIVES The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE). BACKGROUND Catheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have relative and absolute contraindications to thrombolysis. METHODS Patients with symptomatic, computed tomography-documented PE and RV/left ventricular (LV) ratios >= 0.9 were eligible for enrollment. The primary effectiveness endpoint was core laboratory-assessed change in RV/LV ratio. The primary safety endpoint comprised device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy. RESULTS From April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up. CONCLUSIONS Percutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding. Potential advantages include immediate thrombus removal, absence of thrombolytic complications, and reduced need for post-procedural critical care. (C) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
OBJECTIVE:Although duplex ultrasound (DUS) imaging is the current gold standard in the diagnosis of femoropopliteal deep venous thrombosis, it is not an optimal diagnostic modality to diagnose iliocaval occlusion. Screening for iliocaval occlusion thus remains a challenge for clinicians because of the lack of a reliable noninvasive technique. This challenge results in most patients undergoing computed tomography venography or magnetic resonance venography or invasive venography and intravascular ultrasound imaging. This study reports a novel, yet simple, reproducible and intuitive, surface DUS finding of physiologic flow reversal within the superficial epigastric vein (SEV) as a sign of proximal iliocaval occlusion (ICO).METHODS:This was a retrospective study of 15 patients who were diagnosed with ICO based on the finding of SEV flow reversal on DUS imaging. Patient demographics, presenting CEAP C scores, ICO characteristics, correlation with advanced imaging, and short-term follow-up findings are reported.RESULTS:Physiologic reversal of the SEV resulted in confirmation of ICO in all patients who underwent advanced imaging, including computed tomography venography or traditional venogram along with intravascular ultrasound imaging. All patients who underwent follow-up DUS scans demonstrated normalization of the SEV flow after ICO recanalization.CONCLUSIONS:ICO can result in deep venous thrombosis, post-thrombotic syndrome, and chronic venous insufficiency. Physiologic flow reversal in SEV is diagnostic of ICO. To the best of our knowledge, this is the first report of this novel DUS finding.
Since the approval of retrievable Inferior Vena Cava (IVC) filters in 2001, their use has dramatically increased as the threshold for use has been lowered. Recent studies have shown a disappointing 26p retrieval rate, of which only 74p were successful. To this end, in August 2010, the