Quality of anticoagulant therapy and the incidence of in-stent thrombosis after venous stenting.

BACKGROUND: In patients with a venous outflow obstruction following iliofemoral deep vein thrombosis stenting of the venous tract to prevent or alleviate postthrombotic syndrome is applied with increasing frequency. The impact of the quality of anticoagulant therapy with vitamin K antagonists (VKAs) on the development of in-stent thrombosis is currently unknown. OBJECTIVES: To determine the association between the quality of postinterventional VKA treatment and the occurrence of in-stent thrombosis. METHODS: Seventy-nine patients with iliofemoral and/or caval venous stent placement for obstruction of the venous outflow were included in this study. All patients received postinterventional VKA. The quality of VKA anticoagulant therapy was expressed as the time within therapeutic range (TTR) calculated using the linear interpolation method and as the proportion of International Normalized Ratio (INR) values < 2.0. In-stent thrombosis was assessed by the use of duplex ultrasound. Survival analysis (Kaplan-Meier curves, Cox regression) was used to analyze the data. RESULTS: In-stent thrombosis developed in 16 patients (20.3%). The total population had a mean TTR of 64.0% (±19.0) and a mean proportion of INR values < 2.0 of 11.6% (±12.0). Overall, a TTR < 49.9% was associated with an increased risk of in-stent thrombosis. The multivariable adjusted analysis showed a hazard ratio (HR) of 0.96 (95% confidence interval [CI], 0.92-0.99; P = .02) per 1% increase in TTR. The proportion of INR values < 2.0 had no significant association with the occurrence of in-stent thrombosis: HR 0.98 (95% CI, 0.91-1.06; P = .66). CONCLUSIONS: We conclude that the quality of anticoagulant treatment reflected in the TTR following a venous stenting procedure is an important independent determinant for the risk of in-stent thrombosis. The role of anticoagulant treatment for the prevention of in-stent thrombosis following stenting procedures therefore merits further research.

Closed incisional negative pressure therapy may reduce surgical site infection rate following endophlebectomy with complementary polytetrafluoroethylene arteriovenous fistula of the common femoral vein.

OBJECTIVE: Surgical desobliteration or endophlebectomy of the common femoral vein during deep venous recanalization with complementary polytetrafluoroethylene (PTFE) arteriovenous fistula (AVF), may lead to higher rates of surgical site infection (SSI). It has been reported that closed incisional negative pressure wound therapy (cINPT) may decrease SSI rates after different surgical procedures. The aim of this study was to determine the potential effect of cINPT on the SSI rate of femoral endophlebectomy with a complimentary PTFE AVF. METHODS: Patients with recanalization of the femoral-iliac veins and femoral endophlebectomy with a complementary PTFE AVF and postoperative cINPT were identified. SSI, patency, and complication rates were analyzed. RESULTS: This study included 65 patients with a mean age of 41 ± 14 years. The mean procedure time was 240 ± 11.9 minutes. Primary patency rate was 69.2% and secondary patency rate was 78.4%. SSI classified as Szilagyi I, II, and III occurred in 7.6% (n = 5), 3% (n = 2), and 7.6% (n = 5), respectively, with an overall SSI rate of 18.2%. Surgical wound revision with the application of a vacuum pump was required in 10.7% (n = 7). A multivariate analysis showed that the duration of the surgical procedure (P = .003) as well as lymphatic fistulas (P = .044) to have a significant impact on the SSI rate. CONCLUSIONS: Endophlebectomy with complementary PTFE AVF of the femoral vein is related to an increased rate of lymphatic leakage and SSI. Lymphatic fistula and the duration of surgery could be assessed as relevant influencing factors of SSI. Application of cINPT in this surgical setting may reduce the SSI rate. Despite this potential improvement, SSI rates still limit the clinical success of a deep venous recanalization.

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.

The Effect of Stenting on Venous Hypertension: Results Using a Treadmill Stress Test with Invasive Pressure Measurements in Patients with Iliofemoral Venous Obstruction.

OBJECTIVES: The primary aim was to investigate whether stenting of post-thrombotic iliofemoral obstruction reduces venous hypertension. The secondary aim was to establish whether improvement in haemodynamic parameters impacts on quality of life. METHODS: In this prospective observational study, 12 participants with unilateral post-thrombotic obstruction of the iliac and/or common femoral veins (CFVs) underwent a treadmill stress test with invasive pressure measurements in the CFVs and dorsal foot veins of both affected and non-affected limbs. This was performed the day before and 3 months after stenting the obstructed tract. Paired sample t-tests were used to compare the treatment effect and univariable linear regression analysis to determine the association with improvement in quality of life. RESULTS: Before treatment, CFV pressure increased 34.8 ± 23.1 mmHg during walking in affected limbs compared with 3.9 ± 5.8 mmHg in non-affected limbs. This pressure rise decreased to 22.3 ± 24.8 mmHg after 3 months follow up compared with a 4.0 ± 6.0 mmHg increase in non-affected limbs (-26.2 mmHg difference; 95% CI -41.2 to -11.3). No such effect was found in the dorsal foot veins. The VEINES-QOL increased 25.3 ± 11.3 points after stenting and was significantly associated with a decrease in CFV pressure rise during walking (regression coefficient 0.4; 95% CI 0.1-0.6). CONCLUSION: Stenting of post-thrombotic iliofemoral obstruction significantly reduces venous hypertension in the common femoral vein and correlates with an improvement in the quality of life. Larger studies with a broader range of degree of obstruction need be performed to assess whether pre-stenting pressure measurements can predict post stenting clinical success.

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.

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.

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.

Radial force measurements in carotid stents: influence of stent design and length of the lesion.

PURPOSE: To assess the differences in radial force of carotid stents and whether the length of the lesion influences the measurements. MATERIALS AND METHODS: Different models of tapered stents of similar size (length, 30 mm) were used. The tapered nitinol Acculink, Protégé, and Cristallo Ideale carotid artery stents and the straight, braided Elgiloy carotid Wallstent were compared. A measurement device consisting of three film loops along the stent body connected to aluminium rods with copper strain gauges was developed. Five stents of each type were deployed within 3-mm stenoses in simulated long (26 mm) and short (8 mm) stenoses. RESULTS: In the short stenosis simulation, the greatest radial force was seen in the Protégé stent, at 3.14 N ± 0.45, followed by the Cristallo Ideale stent (1.73 N ± 0.51), Acculink (1.16 N ± 0.21), and Wallstent (0.84 N ± 0.10; P < .001). In the long stenosis simulation, peak radial force again was highest in the Protégé stent (1.67 N ± 0.37), but the Acculink stent was second (0.95 N ± 0.12) and the Wallstent third (0.80 N ± 0.06). The Cristallo Ideale stent, in contrast to the short stenosis simulation, produced the least radial force (0.44 N ± 0.13) in the long stenosis simulation (P = .001). CONCLUSIONS: Radial forces exerted by carotid stents vary significantly among stent designs. Differences between stent types are dependent on the length of the stenosis. An understanding of radial force is necessary for a well-considered choice of stent type in each individual patient.

Carotid endarterectomy for treatment of in-stent restenosis after carotid angioplasty and stenting.

OBJECTIVE: Carotid angioplasty and stenting (CAS) has emerged as an alternative for carotid endarterectomy (CEA) in the prevention of stroke. The benefit of the procedure, however, is hampered by a suggested higher incidence of in-stent restenosis (ISR) for CAS relative to CEA during follow-up. ISR management remains a challenge for clinicians. In this observational retrospective analysis, we evaluated the operative management of ISR by standard CEA with stent removal, including midterm follow-up in 15 patients. METHODS: The present analysis included 15 patients from three Dutch vascular centers who underwent CEA for symptomatic (n = 10) or hemodynamically significant (≥80%) asymptomatic ISR (n = 5). Median time between CAS and CEA was 18.3 months (range, 0-51 months). RESULTS: Standard CEA with stent removal was performed in all 15 patients. A Javid shunt was used in two procedures. One patient sustained an intraoperative minor ischemic stroke, with complete recovery during the first postoperative days. No neurologic complications occurred in the other 14 patients. Two patients required a reoperation to evacuate a neck hematoma. There were no peripheral nerve complications. After a median follow-up of 21 months (range, 3-100 months), all 15 patients remained asymptomatic and without recurrent restenosis (≥50%) on duplex ultrasound imaging. CONCLUSION: CEA with stent explantation for ISR after CAS seems an effective and durable therapeutic option, albeit with potential cerebral and bleeding complications, as in this study. The optimal treatment for carotid ISR, however, has yet to be defined.

The influence of aneurysm size on perioperative cardiac outcome in elective open infrarenal aortic aneurysm repair.

BACKGROUND: Abdominal aortic aneurysm (AAA) size and growth has been found to be associated with local generation of inflammation markers such as interleukin-6. Inflammation also seems to be important in perioperative adverse cardiac events. We hypothesized that patients with a large AAA are at increased risk for cardiac events. METHODS: Consecutive patients who underwent a computed tomography angiography scan before open elective infrarenal AAA repair between March 2000 and December 2005 at three hospitals were analyzed. All patients were screened for the clinical risk factors of age, gender, angina pectoris, myocardial infarction, heart failure, diabetes, stroke, renal failure, and chronic obstructive pulmonary disease, as well as for cardioprotective medication. Postoperative data on troponin release, creatine kinase/creatine kinase isoenzyme MB, and electrocardiogram were routinely collected on days 1, 3, 7, and 30. The main outcome measure was the combined end point of 30-day cardiovascular death and nonfatal myocardial infarction. Multivariate Cox regression analysis was used to evaluate the influence of AAA size on postoperative cardiac outcome. RESULTS: The study included 500 patients. Their mean age was 69.8 +/- 9.5 years, and 431 (86%) were men. Thirty-one patients (6.2%) had perioperative cardiovascular complications, consisting of 15 (3.0%) cardiovascular deaths and 16 (3.2%) nonfatal myocardial infarctions. After correction for other risk factors, including age, Revised Cardiac Risk Index, medication use, duration of surgery, and intraoperative blood loss, AAA size was independently associated with perioperative nonfatal myocardial infarction and cardiovascular death (3.2% increase in risk for each millimeter added, 95% confidence interval 1.1% to 6.2%, P = .007). CONCLUSION: A larger AAA size is independently associated with an increased incidence of perioperative cardiovascular complications after elective infrarenal AAA repair.