Jorinde van Laanen

A randomised controlled trial comparing venous stenting with conservative treatment in patients with deep venous obstruction: research protocol

Introduction Deep venous obstruction (DVO) has a great impact on quality of life (QoL) comparable to angina pectoris or chronic pulmonary disease. Post-thrombotic scar formation and May-Thurner syndrome (MTS) are the most common causes of DVO. Conventional treatment of DVO focuses on reducing pain or leg swelling by use of (pain) medication and therapeutic elastic stockings. In the past, a venous bypass was offered in severe post-thrombotic cases, but this procedure showed bad clinical and patency outcomes. With the introduction of percutaneous angioplasty and dedicated venous stents new opportunities were created. Deep venous stenting has been shown to be effective in retrospective case series. However, there is no prior research in which QoL after interventional treatment is compared with QoL after conventional treatment. Currently, there is a debate about the true additional value of interventional treatment. We investigate whether those patients who are treated with stenting experience a change in short form 36 (SF-36) and the Veines-QoL/Sym questionnaires compared with conventionally treated patients. Methods and analysis This is a randomised trial comparing conservative deep venous management to interventional treatment. A total of 130 patients with post-thrombotic syndrome (PTS) or MTS, eligible for interventional percutaneous treatment, who did not have previous deep venous intervention will be included. Patients will be randomised to conservative treatment or venous stenting and stratified for the PTS or MTS subgroup. Conservative treatment consists of either one or a combination of pain medications, manual lymphatic drainage, compression stockings and regular post-thrombotic anticoagulant therapy. The primary outcome is the QoL change after 12 months compared with baseline QoL. Secondary outcomes are QoL changes at 6 weeks, clinical assessment of DVO, recurrence rate of deep venous thrombosis at 6 weeks and 12 months, and the total amount of working days lost. Intervention-specific outcomes include complications and patency. Ethics and dissemination The protocol is approved by the Medical Ethics Committee of Academisch ziekenhuis Maastricht/Universiteit Maastricht, The Netherlands (protocol number NLNL55641.068.15 / METC 161008).We aim to publish the results of this study in a peer reviewed journal and present our findings at national or international conferences. Trial registration number The study protocol was registered at www.clinicaltrials.gov (registration number: NCT03026049) on 17 January 2017.

The value of intravascular ultrasound in the treatment of central venous obstructions in hemodialysis patients.

Introduction Digital subtraction angiography (DSA) is the gold standard in diagnosis and treatment of central venous obstructions (CVOs) in hemodialysis access. However, growing data suggest that DSA might underestimate the degree and morphology of venous outflow stenosis. This could lead to inappropriate CVO management. Intravascular ultrasound (IVUS) has been shown to identify lesion characteristics remaining obscure with angiography. With the current study we suggest IVUS as an eminent imaging modality in CVO management. Methods Twelve patients (8 male, mean age 62.4 ± 9 years) were analyzed for suspicion of symptomatic CVO. Both angiography and IVUS evaluation were performed to determine the degree of obstruction before and after PTA. Stent placement was indicated when significant residual stenosis (>50% lumen reduction) was suspected. Results Conventional plain angiography determined 8 out of 12 central venous lesions significant. Secondary signs of obstruction, i.e., collateral filling, was present in all 12 cases. After PTA, persistent significant stenosis was observed in 3 out of 12 patients. IVUS showed significant lumen reduction in all 12 cases. Additionally, IVUS showed a median cross-sectional area of 24 ± 12 mm2 before PTA and 37 ± 23 mm2 after PTA (NS). Furthermore, IVUS showed signs of intraluminal fibrotic trabeculations in 9 patients. Stenting was performed in 10 patients with >50% lumen reduction on IVUS after PTA. Conclusions Conventional angiography seems unreliable to identify all significant aspects of a central venous outflow obstruction. Additional use of IVUS might aid in the decision-making process and select the optimal treatment strategy.

Hemodialysis vascular access management in the Netherlands

Purpose In the Netherlands, 86% of patients start renal replacement therapy with chronic intermittent hemodialysis (HD). Guidelines do indicate predialysis care and maintenance of a well-functioning vascular access (VA) as critical issues in the management of the renal failure patient. Referral to the surgeon and time to VA creation are important determinants of the type and success of the VA and HD treatment. Methods and Results Data from a national questionnaire showed that time from referral to the surgeon and actual access creation is <4 weeks in 43%, 4 to 8 weeks in 30% and >8 weeks in 27% of the centers. Pre-Operative ultrasonography and postoperative access flowmetry are the diagnostic methods in the majority of centers (98%). Most facilities perform rope-ladder cannulation with occasionally the buttonhole technique for selected patients in 87% of the dialysis units. Endovascular intervention for thrombosis is practiced by 13%, surgical thrombectomy by 21% and either endovascular or surgery by 66% of the centers. Weekly multidisciplinary meetings are organized in 57% of the units. Central vein catheters are inserted by radiologists (36%), nephrologists and surgeons (32%). Conclusions We conclude that guidelines implementation has been successful in particular regarding issues as pre-operative patient assessment for VA creation and postoperative surveillance in combination with (preemptive) endovascular intervention, leading to very acceptable VA thrombosis rates.

Revision techniques for failed PD catheters: outcome in a University Hospital

Purpose A disfunctioning peritoneal dialysis (PD) catheter has been reported in upto 35%. We report different salvage techniques used and its outcome. Methods We retrospectively reviewed our database on PD patients from 2009 to 2014. Operational data and data on PD catheter function were checked. Results From 2009 to 2014, we operated on 32 patients. Malfunction of their PD catheter was found in 23 patients and hernias in nine patients. Different laparoscopic techniques were used, including reposition of the catheter, fixation of the catheter, removal of adhesions and omentectomy. Of these 23 patients, 18 (78%) had a normal functioning catheter after the operation. Nine patients of the total of 32 patients had a correction of their hernia. In all cases, a non-absorbable mesh was used. Of those nine patients with a hernia, eight (89%) had a normal functioning catheter after the procedure. Conclusions The salvage of the catheter by means of a laparoscopic procedure or correction of a hernia is worthwhile and can save up to 81% of the catheters.

Long segment recanalization and dedicated central venous stenting in an ultimate attempt to restore vascular access central vein outflow

Purpose Maintaining vascular access in patients undergoing chronic hemodialysis is a challenging process, especially in patients enduring multiple central line placements and in whom peripheral options have been exhausted. Case We present a case of a 60-year-old male without options for peripheral vascular access due to multiple failed arteriovenous fistulas for hemodialysis. Furthermore, bilateral subclavian, brachiocephalic veins and iliac veins were occluded or significantly obstructed. After long segment central vein recanalization, an upper arm loop arteriovenous graft was implanted. The recanalized segment was stented with a 12-mm dedicated venous nitinol stent. Conclusion Chronic central vein obstructions demand stents with both high radial force and flexibility. We recommend dedicated venous stents to improve technical success and reduce stent-related complications like early re-occlusion due to fracturing, kinking or straightening.

Stent extension into a single inflow vessel is a valuable option after endophlebectomy

Background Venous stenting with an endophlebectomy and arteriovenous fistula can be performed in patients with extensive post-thrombotic changes. However, these hybrid procedures can induce restenosis, sometimes requiring stent extension, into a single inflow vessel. This study investigates the effectiveness of stenting into a single inflow vessel. Methods All evaluated patients had temporary balloon occlusion of the arteriovenous fistula to evaluate venous flow into the stents. When stent inflow was deemed insufficient, AVF closure was postponed and additional stenting was performed. Patency rates and clinical outcomes were evaluated. Results Twenty-four (38%) of 64 patients had additional stenting. The primary, assisted primary and secondary patency were 60 %, 70% and 70% respectively. Villalta score reduced by 6.1 points (p < 0.001), and venous clinical severity score by 2.7 points (p = 0.034). Conclusion Stenting through the femoral confluence into a single inflow vessel is a feasible bailout option if primary hybrid intervention fails with relative high patency rates and clinical improvement.

Endovascular Treatment of a Renocaval Arteriovenous Fistula Induced Inferior Vena Cava Aneurysm

Caval aneurysms are very rare but potentially lethal. Discussion about the need for treatment rises on individual basis. Based on the underlying etiology, a well-considered treatment plan should be made. Possible complications for invasive treatment and conservative management should be carefully weighed against each other. We present a patient with a caval aneurysm due to an arteriovenous fistula which we treated with endovascular embolization. Six months after treatment the patient is asymptomatic and the aneurysm size is decreased.

Randomized Controlled Trial Comparing Open Versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The CAPD I Trial

Objective: To determine the best operation technique, open versus laparoscopic, for insertion of a peritoneal dialysis (PD) catheter with regard to clinical success. Clinical success was defined as an adequate function of the catheter 2 – 4 weeks after insertion. Methods: All patients with end-stage renal disease who were suitable for PD and gave informed consent were randomized for either open surgery or laparoscopic surgery. A previous laparotomy was not considered an exclusion criterion. Laparoscopic placement had the advantage of pre-peritoneal tunneling, the possibility for adhesiolysis, and placement of the catheter under direct vision. Catheter fixation techniques, omentopexy, or other adjunct procedures were not performed. Other measured parameters were in-hospital morbidity and mortality and post-operative infections. Results: Between 2010 and 2016, 95 patients were randomized to this study protocol. After exclusion of 5 patients for various reasons, 44 patients received an open procedure and 46 patients a laparoscopic procedure. Gender, age, body mass index (BMI), hypertension, current hemodialysis, severe heart failure, and previous an abdominal operation were not significantly different between the groups. However, in the open surgery group, fewer patients had a previous median laparotomy compared with the laparoscopic group (6 vs 16 patients; p = 0.027). There was no statistically significant difference in mean operation time (36 ± 24 vs 38 ± 15 minutes) and hospital stay (2.1 ± 2.7 vs 3.1 ± 7.3 days) between the groups. In the open surgery group 77% of the patients had an adequate functioning catheter 2 – 4 weeks after insertion compared with 70% of patients in the laparoscopic group (p = not significant [NS]). In the open surgery group there was 1 post-operative death (2%) compared with none in the laparoscopic group (p = NS). The morbidity in both groups was low and not significantly different. In the open surgery group, 2 patients had an exit-site infection and 1 patient had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. Conclusion: This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome.

Illusory Angiographic Signs of Significant Iliac Vein Compression in Healthy Volunteers

OBJECTIVE Iliac vein compression syndrome can cause severe leg symptoms. In clinical practice, it remains a challenge to differentiate which compression is clinically relevant. The aim of the current study was to assess the general treatment indications and the prevalence of angiographic signs of iliac vein compression in a group of healthy participants. METHODS This was a prospective cohort study. A total of 20 healthy volunteers (median age 21, range 20-22 years) were recruited through advertisement and underwent angiography of the iliac veins. When no compression signs were present, a balloon occlusion was performed. Additionally, a 10 item survey regarding indications for venous stenting was developed and sent to 30 vascular specialists treating patients with deep venous obstruction. RESULTS In 16 (80%) participants, at least two signs indicative of May-Thurner compression were seen. In three (15%) subjects, narrowing of the common iliac vein without collaterals was shown and one (5%) did not show any signs of obstruction. In 23 (70%) of the survey responders, collaterals were found to be the most typical sign indicative of significant venous obstruction. An angiographic sign of >50% compression was found to be an indication to stent in 55% of responders. CONCLUSION This study demonstrates a remarkably high percentage of generally accepted signs of significant iliac vein obstruction (May-Thurner compression) on venography in healthy young subjects. Diagnosis of true iliac vein obstruction remains a major challenge, which mostly leans on improvement of clinical symptoms rather than imaging findings. Treating the patient rather than the image seems to be a valid principle all the more.