Utility of a Mechanical Thrombectomy Device in Treating Calcified Instent Restenosis Post Iliofemoral Venous Stenting.

Instent restenosis (ISR) following iliofemoral venous stenting is quite common with up to three-quarters of patients developing some degree of ISR. However, only around 16% develop recurrent symptoms impairing their quality-of-life meriting reintervention. The first line of treatment for such ISR involves the use of angioplasty balloons to recreate an adequate flow channel. At times such angioplasty alone is inadequate particularly in the presence of calcified ISR. It is in this setting that the authors decided to explore the utility of a mechanical thrombectomy device to debulk the ISR and thereby help create an adequate flow channel. The successful utilization of such a device in a patient presenting with recurrent, disabling, quality of life impairing symptoms due to ISR represents the focus of this report.

Dimensional disparity between duplex and intravascular ultrasound in the assessment of iliac vein stenosis.

Minimum iliac vein caliber necessary to maintain normal peripheral venous pressure can be derived by the Poiseuille equation. Duplex was compared to intravascular ultrasound (IVUS) in the assessment of iliac vein stenosis in this single center retrospective study. Parallel IVUS and duplex caliber data for common iliac vein (CIV) and external iliac vein (EIV) in 382 limbs were separately compared. One or both segments were stenotic by IVUS criteria in 213 limbs. Neither segment was stenotic by IVUS in 22 limbs. Bland-Altman analyses and Passing-Bablok linear regressions were used. Duplex calibers were dimensionally smaller than corresponding IVUS images of CIV and EIV segments in Bland-Altman comparison by a mean of 54 mm2 and 34 mm2, respectively. Passing-Bablok regression suggested the difference was due to a systematic bias and not proportional. Duplex yields a smaller cross-sectional image of CIV and EIV compared to IVUS. Duplex is not a reliable diagnostic test for iliac vein stenosis.

Impact of Presence of Inferior Vena Cava Filter on Iliocaval Stent Outcomes.

BACKGROUND: The impact of presence of an IVC filter in patients undergoing stenting for symptomatic femoroiliocaval obstruction has not been explored in detail. This study attempts to fill this gap by evaluating clinical and stent-related outcomes in such patients. The incidence of deep vein thrombosis (DVT) in this setting is also analyzed. METHODS: A retrospective review of contemporaneously entered EMR data on initial iliocaval stents placed in patients with an indwelling IVC filter (or placed after stenting) over a 15-year period from 2000 to 2015 was performed. A separate matched cohort that underwent initial stenting during the time frame, but which did not have an IVC filter, was utilized as the control group. Clinical outcomes were evaluated through use of the venous clinical severity score (VCSS) and visual analog scale (VAS) pain scores. Incidence of deep venous thrombosis after stenting was also reviewed in both groups. The Kaplan-Meier analysis was used to assess stent patency after intervention while t-tests were used to examine preintervention and postintervention outcomes within and in-between groups. RESULTS: A total of 50 limbs (40 patients) underwent placement of a femoroiliocaval stent in the setting of a preexisting (49) or post-stent (1) IVC filter [filter group]. The control group had 156 limbs (155 patients). There was no difference in VCSS, VAS pain score, or grade of swelling at baseline between the 2 groups. Over the median follow-up duration (43 months-filter group; 40 months-control group), VCSS went from 6 to 4 at 12 months (P = 0.0001) in the filter group and from 6 to 4 in the control group (P < 0.0001). VAS pain scores went from 7 to 0 at 12 months (P < 0.0001) in the filter group and from 5 to 0 in the control group (P < 0.0001). There was no significant difference in the VCSS scores or VAS pain score between the 2 groups at 12 months (P > 0.05). Overall, there was a statistically significant increase in the incidence of DVT in the filter group (10%) compared to the control group (3%) [P = 0.03%]. Primary, primary assisted, and secondary patencies in the filter/control groups at 48 months were 64%/65% (P = 0.6), 100%/97% (P = 0.5), and 100%/75% (P = 0.4), respectively. Reintervention from in-stent restenosis was noted in 16% of patients in the filter group compared to 4% in the control group (P = 0.006). CONCLUSIONS: Patients with an IVC filter in the setting of a femoroiliocaval stent tend to have an increased rate of deep venous thrombosis on the stented side. In addition, an increased rate of reintervention secondary to in-stent restenosis was also noted. In light of this, every attempt should be made to remove the IVC filter as soon as the need for the filter no longer exists.

A modification of iliac vein stent technique.

BACKGROUND: Iliac vein stenting has emerged as a promising new technology to address a wide spectrum of advanced chronic venous disease. Wallstent™ has been the commonest stent type used in reported experience. It has excellent long-term patency with good clinical outcome, but is prone to compression/migration of the upper end of the stent requiring reinterventions. Extension of the stent into the vena cava to avoid this problem may render subsequent contralateral stenting technically difficult and possibly contribute to partial jailing of contralateral flow. A technical modification in which a Gianturco Z stent™ is added to the upper end of the Wallstent stack that may ameliorate some of these concerns is described. METHODS: The details of technique, complications, patency, and reinterventional rate of the Z stent modification in 217 limbs followed up to 24 months are reported. RESULTS: Cumulative primary and secondary patency (24 months) were 69% and 93%, respectively. Eight stents were occluded and lysis restored patency in 6 patients. There was no mortality. Deep venous thrombosis (<30 day) occurred in 4% of patients similar to the incidence in native disease. Reinterventions were required in 11% of patients over the follow-up period to correct stent malfunction. Most of these (23/25) were related to the Wallstent tail of the combination stent stack. The Z stent modification provides increased radial strength at the iliac-caval junction which is a choke point. The Z stent modifications greatly facilitate staged or sequential bilateral stenting technique and may reduce the incidence of reinterventions related to retraction or compression of the upper end commonly seen with prior Wallstent experience. CONCLUSION: The Z stent modification appears to improve functionality of the stent stack at the upper end and greatly facilitates simultaneous or staged bilateral stenting technique.

Noninvasive measurement of ambulatory venous pressure via column interruption duration in chronic venous disease.

BACKGROUND: Column interruption duration (CID) is a noninvasive surrogate for venous refill time (VFT), a parameter used in ambulatory venous pressure measurement. CID is more accurate than invasive VFT measurement because it avoids errors involved with indirect access of the deep system through the dorsal foot vein. The aim of this retrospective single center study is to analyze the clinical usefulness of CID in assessment of chronic venous disease (CVD). METHODS: A total of 1551 limbs (777 patients) were referred with CVD symptoms over a 5-year period (2018-2023); CID, air plethysmography, and duplex reflux data were analyzed. Of these limbs, 679 had supine venous pressure data as well. The pathology was categorized as obstruction if supine peripheral venous pressure was >11 mm Hg and as reflux if duplex reflux time in superficial or deep veins was >1 second. CID was measured via Doppler monitoring of flow in the great saphenous vein (GSV) and one of the paired posterior tibial (PT) veins near the ankle in the erect posture. The calf is emptied by rapid inflation cuff. CID is the time interval in seconds when cephalad venous flow in great saphenous vein and posterior tibial veins reappear after calf ejection. A CID <20 seconds in either vein is abnormal similar to the threshold used in VFT measurement. RESULTS: Thirty-two percent of the limbs had obstruction, 17% had reflux, and 37% had a combination; 14% had neither. Higher clinical-etiology-anatomy-pathophysiology (CEAP) clinical classes (C4-6) were prevalent in 44% of pure reflux, significantly less (P < .0001) than in pure obstruction (73%) or obstruction plus reflux subsets (72%), partly reflecting distribution of pathology. There is a progressive increase in supine venous pressure and abnormal CID (P < .0001 and P < .0001, respectively) in successive CEAP clinical class. No such correlation between CEAP and any of the reflux severity grading methods (reflux segment score, Venous Filling Index, and Kistner axial grading) was observed. Abnormal CID (55%) was more prevalent in higher CEAP classes (>4) (P < .0001) than in lesser clinical classes (0-2) or limbs with neither obstruction nor reflux (P < .01). CONCLUSIONS: Obstruction seems to be a more dominant pathology in clinical progression among CEAP clinical classes than reflux. CID is abnormal in both obstructive and refluxive pathologies and may represent a common end pathway for similar clinical manifestations (eg, ulcer). These data suggest a useful role for CID measurement in clinical assessment of limbs with CVD.

Venous thromboembolism swine model with reflux-induced venous hypertension.

Objective: This study describes a novel swine model of venous thromboembolism (VTE) with reflux-induced venous hypertension. Methods: Six pigs underwent disruption of the tricuspid chordae tendineae to create reflux and venous hypertension in the femoral vein. The vein was traumatized 2 to 3 weeks later by repeated withdrawal of a slightly overinflated occlusion balloon across the lumen, followed by balloon occlusion of the outflow. A small amount of thrombin was injected into the traumatized vein segment immediately after outflow occlusion. Thrombosis of the traumatized vein evolved into an organized thrombus seven weeks later. The histological features of the harvested post-thrombotic femoral vein were studied with hematoxylin and eosin and Trichrome stains. Results: In all six pigs, initial disruption of the chordae tendineae was successfully performed to create tricuspid reflux and venous hypertension. After two-stage sequential procedures, a thrombus formed in the target femoral vein segment. Histology of the harvested thrombotic vein showed features of an organizing thrombus with collagen formation and fibrosis. Conclusions: The novel swine VTE model may serve as a platform for developing and testing human-sized therapeutic procedures and devices in translational venous research. Clinical Relevance: This study describes a swine model of VTE created by incorporating all three elements of Virchow's triad. The model uniquely incorporates reflux-induced venous hypertension, which may be used in studying venous insufficiency and VTE in those with systemic venous hypertension. Likewise, this model may serve as a platform for development and evaluation of diagnostic imaging or therapeutic procedures and devices in subjects with systemic venous hypertension.

Best management options for chronic iliac vein stenosis and occlusion.

BACKGROUND: Iliac vein stenting technology is rapidly emerging as a minimally invasive alternative to traditional open venovenous bypass procedures for iliac vein stenoses and chronic total occlusions. METHODS: Peer-reviewed publications meeting eligibility criteria were retrieved and reviewed from public domain databases. RESULTS: Reviewed reports encompass ∼1500 patients. Evidence quality was judged moderate, with a grade 1B recommendation (benefits outweigh risks) for patients with disabling symptoms in whom conservative therapy had failed. A grade 2B recommendation was assigned for patients with less severe symptoms. Iliac vein stenting is safe, with negligible morbidity (<1%). Patency was 90% to 100% for nonthrombotic disease and 74% to 89% for post-thrombotic disease at 3 to 5 years. Clinical relief of pain was 86% to 94%, and relief from swelling was 66% to 89%. From 58% to 89% of venous ulcers healed. Procedural success in recanalization of chronic total occlusions was 83% to 95%. Hybrid techniques for complex cases are in evolution. CONCLUSIONS: Iliac vein stenting is emerging as a safe and effective alternative to traditional open surgery to correct iliac vein obstruction.

Comparison between a dedicated venous stent and standard composite Wallstent-Z stent approach to iliofemoral venous stenting: Intermediate-term outcomes.

OBJECTIVE: Dedicated venous stents have not been used in the management of symptomatic chronic iliofemoral venous obstruction (CIVO) until recently. The Bard Venovo stent (Becton, Dickinson, and Co, Franklin Lakes, NJ) is one such stent noted to have an increased chronic outward force and radial resistive force compared with the Wallstent (Boston Scientific, Marlborough, MA). In the present study, we evaluated the outcomes following the use of the Bard Venovo stent vs a matched cohort of limbs that had undergone stenting with the Wallstent-Zenith (Z) stent (Cook Medical Inc, Bloomington, IN) composite configuration. METHODS: A review of contemporaneously entered electronic medical record data for 167 patients (167 limbs) with initial iliofemoral stents placed from 2019 to 2020 for quality of life (QOL)-impairing CIVO that had failed conservative therapy was performed. The visual analog scale for pain score (score, 0-10), grade of swelling (score, 0-4), venous clinical severity score (score, 0-27), and the 20-item chronic venous insufficiency quality of life questionnaire instrument for QOL were evaluated before and after intervention to assess the effects of stenting. A Kaplan-Meier analysis was used to examine primary, primary-assisted and secondary stent patency, and analysis of variance with repeated measures was used to compare clinical outcomes. RESULTS: A total of 167 limbs had undergone Bard Venovo stenting (56 men and 111 women). Their median age was 61 years. The laterality was right and left in 70 and 97 limbs, respectively. Post-thrombotic syndrome was seen in 84 limbs and nonthrombotic iliac vein lesions/May-Thurner syndrome in 83 limbs. At 6 months, the venous clinical severity score had improved from 7 to 4 in the limbs with a unilateral Venovo (UV) stent and from 5 to 4 in the composite Wallstent-Z stent group (P = .9). The grade of swelling had improved from 3 to 1 in the UV group and from 3 to 1 in the composite group (P = .6), and the visual analog scale for pain score had improved from 7 to 2 in the UV group and from 5 to 0 in the composite group (P = .007). At 12 months, ulcers had healed in 53% (8 of 15) of the UV group and 56% (5 of 9) of the composite group (P = .7). The global 20-item chronic venous insufficiency quality of life questionnaire scores had improved from 58 to 28 in the UV group and from 59 to 40 in the composite group (P = .6). The cumulative primary, primary-assisted, and secondary patency at 18 months was 81%, 97%, and 98% in the UV group and 87%, 98%, and 100% in the composite group, respectively (P > .4). No difference in the reintervention rates was noted between the two groups (P = .5). CONCLUSIONS: For patients who had undergone stenting for QOL-impairing CIVO, the results with the Bard Venovo venous stent were comparable to those with the composite Wallstent-Z stent configuration for clinical outcomes, QOL improvement, and stent patency. Further study is, however, required to confirm this improvement in the long term.

Inguinal intranodal lymphangiography reveals a high incidence of suprainguinal lymphatic disease in patients with leg edema undergoing stenting for symptomatic chronic iliofemoral venous obstruction.

OBJECTIVE: Recent studies have emphasized the important role lymphatics play in the drainage of interstitial fluid and edema prevention. Although the infrainguinal lymphatics have been studied in some depth, with patterns of pathology identified, such data above the groin are sparse, especially for patients with phlebolymphedema. The present study attempts to evaluate the status of lymphatic flow above the inguinal ligament in patients presenting with edema and undergoing stenting for symptomatic chronic iliofemoral venous obstruction (CIVO). METHODS: A total of 31 lower limbs that underwent pedal lymphoscintigraphy for leg edema and subsequent stenting for symptomatic CIVO formed the study cohort. Each limb underwent intranodal lymphangiography of an ipsilateral inferior inguinal lymph node (10 mL of lipiodol) at the time of stenting. Fluoroscopic visualization of lipiodol transit was performed at 20, 40, and 60 minutes and 3 hours after injection. Enumeration of the lymph nodes and lymphatic collector vessels from above the inguinal ligament to L1, visualization of the thoracic duct, the time delay to visualization of the thoracic duct, and pathologic changes to the thoracic duct when present were all evaluated. These anomalies were independently scored, with the scores combined to generate a total suprainguinal score (range, 0-3). This score was then compared to the limb's lymphoscintigraphically derived infrainguinal score (total infrainguinal score range, 0-3) using the t test and Spearman correlation. The clinical outcomes (grade of swelling, venous clinical severity score) after stenting were appraised. RESULTS: Of the 30 patients (31 limbs), 18 were women, with left laterality noted in 23 limbs. A nonthrombotic iliac vein lesion occurred in 9 limbs and post-thrombotic syndrome in 22 limbs. Of the 31 limbs, 24 (77%) had suprainguinal lymphatic disease (SLD), with 22 of the 24 limbs having severe SLD and 2, mild SLD. When SLD was compared with infrainguinal lymphatic disease, 6 limbs (19%) had the same degree of involvement above and below the groin (1 with normal and 5 with severe disease), 17 limbs (55%) had more severe SLD, and 8 limbs (26%) had more severe infrainguinal lymphatic disease. Three limbs with normal pedal lymphoscintigraphic findings had severe SLD. The Spearman correlation coefficient for the comparison of SLD and infrainguinal disease in the same limb was 0.1 (P = .69). At baseline, the limbs with severe SLD had the same degree of leg swelling and venous clinical severity score as the limbs with absent to mild SLD (P > .1) with similar improvements after stenting (P > .4). Seven limbs underwent complex decongestive therapy (all with severe SLD and concomitant severe infrainguinal disease in one) to treat significant residual leg edema, with improvement. CONCLUSIONS: SLD appears to be common in patients with leg edema undergoing stenting for symptomatic CIVO. Such disease appears to affect the thoracic duct more commonly. Although patients with persistent or residual leg edema after stenting can benefit from complex decongestive therapy, further workup in the form of inguinal intranodal lymphangiography and targeted intervention might need to be considered for those who do not benefit from such therapy. Further study is warranted.

Assessment of flow mechanics in the lower extremity venous system.

BACKGROUND: The Reynolds number (Re) is a dimensionless parameter that describes fluid flow mechanics. Veins are compliant and collapsible vascular conduits that can accommodate large volume changes in response to small pressure changes. However, only sparse information is available about flow parameters such as the Re in the venous system. METHODS: Bilateral duplex ultrasound examination of 15 healthy volunteers (30 limbs) was performed before and after exercise (four flights of stairs) of the veins of the lower extremity (left and right sides) and inferior vena cava. These volunteers had been confirmed to not have any signs or symptoms of lower extremity venous disease via focused history and physical examination findings. RESULTS: Most of the volunteers were women (73%). Their mean age was 37 ± 12.8 years. The Re was highest in the inferior vena cava among all the veins examined (470 ± 144 before exercise and 589 ± 205 after exercise; P = .04). The association between the change in Re before and after exercise and the specific vein examined was also significant for the right and left external iliac veins, right and left common femoral veins, right and left profunda femoris veins, right and left femoral veins, and right common iliac vein. Resistance and velocity maps for the lower extremity venous system were also created. The velocity increased and the resistance decreased as one moved up the venous tree toward the right atrium. CONCLUSIONS: The Re increased for most of the lower extremity veins after exercise in our healthy volunteers. However, the critical value for turbulent flow was not reached despite the exercise.

Iliac vein stent failure in community practice and results of corrective reinterventions.

OBJECTIVE: The goal of endovenous stenting is to relieve venous obstruction and reduce peripheral venous hypertension by using large caliber venous stents in the presence of adequate venous inflow and outflow for the stented conduit. The aim of this report is to describe the technical reasons and outcomes for reinterventions in a subset of patients who had a history of iliac vein stenting and were now referred to us at a specialty venous clinic for further care. METHODS: From January 2016 to December 2021, records of all patients who were referred to us with a history of iliac vein stenting performed at an outside facility and who had a reoperation performed at our center were retrospectively analyzed. RESULTS: A total of 149 limbs underwent a deep venous reintervention after a failure of a trial of conservative therapy. The mean age of the sample was 57 ± 16 years. The ratio of non-thrombotic iliac vein lesions to post-thrombotic lesions was 1:2.5. The majority of the patients (84%) were CEAP class C4 or higher. The most common reason for reintervention was stent occlusion (74%), followed by iatrogenic stenosis (53%) and in-stent restenosis/shelving (38%). There was a trend for improvement in all clinical parameters (venous clinical severity score, visual analog scale for pain, and edema grade) after the reintervention. Poor inflow was present in 70% of limbs with stent occlusion. The median diameters of stented common femoral vein, external iliac vein, and common iliac vein prior to reintervention were 12, 12, and 13 mm, respectively. The median diameters of stented common femoral vein, external iliac vein, and common iliac vein after reintervention were 14, 15, and 16 mm, respectively. Eighty-eight percent of limbs required at least one further reintervention after initial reoperation. CONCLUSIONS: Venous reoperations are generally infrequent and required in a small number of patients. Poor inflow appeared to be a common cause of stent occlusion. Iatrogenic stenosis is another common reason for venous reoperation and is difficult to fully rectify through current endovascular techniques and tools. Use of intravascular ultrasound planimetry routinely in every deep venous intervention and thorough knowledge of the principles of venous stenting outlined in this report may help forestall the need for reoperative deep venous surgery in some cases.

Plethysmographic features of calf pump failure in chronic venous obstruction and reflux.

BACKGROUND: Calf pump failure (CPF) is a common concept in chronic venous disease. Dorsal vein pressures were originally used to define the pathophysiology. More recently, an abnormal ejection fraction (EF) and residual volume fraction (RVF) with air plethysmography (APG) have been substituted for its diagnosis. The relationship between reflux and calf pump function has been studied extensively. Reflux is thought to be the main cause of CPF, although other mechanisms may play a secondary role. Data mining in our dataset revealed that CPF is frequently found in nonrefluxive limbs-an unexpected finding. We analyzed the APG features of CPF in nonrefluxive limbs of a large cohort of patients investigated for chronic venous disease in our clinic. Data from refluxive limbs (control) seen over the same period was included for comparison. Venous obstructive pathology was variably present in both subsets. Iliac vein stent outcome in CPF limbs from both subsets is included. The role of obstruction in CPF is currently unknown. METHODS: Records of 13,234 limbs in 8813 patients evaluated for suspected chronic venous disease over a 22-year period were analyzed. Prestent and poststent data in 406 CPF limbs (129 nonrefluxive; 277 refluxive) that underwent iliac vein stenting to correct associated stenosis are included. This is a single-center retrospective analysis of prospectively collected data. Duplex and APG data were available for included limbs. A RVF of more than 50% was defined as CPF. A reflux time of greater than 1 second elicited with automated cuffs in the erect position was defined as reflux. RESULTS: There were 7780 (59%) limbs with reflux and 5454 (41%) that were nonrefluxive. Supine venous pressure, an index of venous obstruction, was elevated in both subsets. The incidence of CPF was 25% in refluxive limbs and 16% in nonrefluxive limbs totaling 2790 limbs. Venous volume and venous filling index were significantly elevated (P = .0001) in refluxive limbs compared to nonrefluxive limbs. The EF was diminished (<50%) in all CPF limbs except in a small fraction (n = 427 [3%]). Stent correction of iliac vein stenosis corrected CPF, normalizing the RVF in both subsets. CONCLUSIONS: CPF frequently occurs in nonrefluxive limbs with incidence only slightly less than in refluxive limbs. An RVF of more than 50% seems to be a practical definition of a CPF; an EF of less than 50% is associated with a RVF of greater than 50% in 97% of analyzed limbs. Prospective identification of CPF in limbs with chronic venous disease may allow more detailed investigation of its cause (preload, afterload, neuromuscular pathology or joint immobility, etc) and direct more targeted treatment than currently practiced.

Clinical tolerance of untreated reflux after iliac vein stent placement.

BACKGROUND: We have recently demonstrated in a large patient cohort that the prevalence and severity of reflux will improve in most limbs after stenting and that most limbs will not develop new-onset reflux. In the present report, we have focused on the long-term clinical outcomes associated with untreated reflux in the same patient cohort who had undergone iliofemoral venous stenting without correction of residual reflux. METHODS: The clinical outcomes data from 1379 limbs treated with only iliac vein stenting without correction of superficial or deep reflux from 1997 to 2018 were analyzed (23-year follow-up period). Of the 1379 limbs, 632 (46%) had had preexisting reflux before stenting and 747 (54%) had did not. The reflux data (reflux segmental score, air plethysmography, ambulatory venous pressure) for these patients have been previously reported in detail. The subsets were compared perioperatively with each other using the following variables: grade of swelling, visual analog scale for pain score, venous clinical severity score, venous stasis dermatitis, ulceration, and quality of life measures. RESULTS: Both groups demonstrated improvements in the venous clinical severity score, grade of swelling, visual analog scale score, and quality of life. No differences were found in ulcer healing (5% vs 3% for limbs with and without prestent reflux, respectively) and resolution of dermatitis (6% vs 5% for limbs with and without prestent reflux, respectively) between the two groups. Of the 632 limbs with preexisting reflux, 218 (34%) had had axial reflux and 414 had had nonaxial reflux (66%). The clinical outcomes were similar between the two groups. Using a multisegment reflux score, the limbs with prestent reflux (n = 632) were divided into two groups. A segmental score of ≥3 indicated severe reflux and a score of <3 indicated moderate reflux. Of these 632 limbs, 161 (25%) had severe reflux and 471 (75%) had moderate reflux. The two groups demonstrated similar outcomes for most clinical parameters. The post-thrombotic limbs and nonthrombotic limbs also showed similar outcomes. CONCLUSIONS: The long-term follow-up of patients after iliac vein stenting showed that uncorrected reflux is well tolerated by most patients across most clinical measures.

Conduit design with expanding diameter for enhanced flow.

Conduits are commonly used for treating lesions in arteries and veins. The conventional stents are cylindrical in shape, which increases flow resistance with length. This study presents a design of stents and conduits where the conduit caliber expands gradually to reduce resistance while avoiding flow separation. Inflow was provided from a header tank at two different pressures (i.e., 10 and 25 mm Hg pressure) into a cylindrical or expanding conduit. The initial conduit calibers were 2-, 3-, 4-, and 5-mm and 160-, 310-, and 620-mm lengths in each case. The flow rates of expanding caliber conduits (at a rate of r4-6/cm where r is the initial conduit radius) were compared to traditional cylindrical conduits of constant radius. The expanded caliber yields a significantly increased flow of 16-55% for R4/L expansion, 9-44% for R5/L expansion, and 1-28% for R6/L expansion. Simulated flow models using computational fluid dynamics (CFD) were used to validate and expand the experimental findings. Flow separation was detected for certain simulations by flow pathlines and wall shear stress (WSS) calculations. The results showed that a caliber expansion rate of r6/cm is the optimal rate of expansion for most potential applications with minimum flow separation, lower resistance, and increased flow.

Novel venous balloon for compliance measurement and stent sizing in a post-thrombotic swine model.

Objective: Real-time accurate venous lesion characterization is needed during endovenous interventions for stent deployment. The goal of this study is to validate a novel device for venoplasty sizing and compliance measurements. Methods: A compliance measuring sizing balloon (CMSB) uses real-time electrical conductance measurements based on Ohm's Law to measure the venous size and compliance in conjunction with pressure measurement. The sizing accuracy and repeatability of the CMSB system were performed with phantoms on the bench and in a swine model with an induced post thrombotic (PT) stenosis in the common femoral vein of swine. Results: The accuracy and repeatability of the CMSB system were validated with phantom bench studies of known dimensions in the range of venous diameters. In 9 swine (6 experimental and 3 control animals), the luminal cross-sectional areas (CSA) increased heterogeneously along the PT stenosis when the CMSB system was inflated by stepwise pressures. The PT stenosis showed lower compliance compared to the non-PT vein segments (5 mm2 vs. 10 mm2 and 13 mm2 at a pressure change of 40 cm H2O). Compliance had no statistical difference between venous hypertension (VHT) and Control. Compliance at PT stenosis, however, was significantly smaller than that at Control and VHT (p < 0.05, ANOVA). Conclusion: The CMSB system provides accurate, repeatable, real-time measurements of CSA and compliance for assessment of venous lesions to guide interventions. These findings provide the impetus for future first-in-human studies.

Diagnosis and treatment of venous lymphedema.

BACKGROUND: Chronic venous disease (CVD) is a common cause of secondary lymphedema. Venous lymphedema is sometimes misdiagnosed as primary lymphedema and does not receive optimal treatment. We have routinely used intravascular ultrasound (IVUS) imaging in all cases of limb swelling. The aim of this study is to show that (1) routine use of IVUS can detect venous obstruction missed by traditional venous testing, and (2) iliac-caval venous stenting can yield satisfactory clinical relief and can sometimes reverse abnormal lymphangiographic findings. METHODS: The study comprised CVD patients who underwent iliac vein stenting. Lymphangiography was abnormal in 72 of 443 CEAP C(3) limbs, with leg swelling as the primary complaint (abnormal lymphangiography group). Clinical features and stent outcome were compared with a control group of 205 of 443 with normal lymphangiography (normal lymphangiographic group). RESULTS: Clinical features were a poor guide to the diagnosis of lymphedema. Isotope lymphangiography was not helpful in differentiating primary from secondary lymphedema. Venography had 61% sensitivity to the diagnosis of venous obstruction. IVUS had a sensitivity of 88% for significant (≥50% area stenosis) venous obstruction. At 40 months, cumulative secondary stent patency was similar for the abnormal (100%) and normal lymphangiographic (95%) groups. Swelling improved significantly after stent placement in the abnormal lymphangiographic group (mean [standard deviation] swelling grade improvement 0.8 ± 1.1) but was less (P < .004) than in the control group (1.4 ± 1.3). Complete swelling relief was 16% and 44% (P < .001) and partial improvement (≥1 grade of swelling) was 45% and 66% (P < .01) in the abnormal and normal lymphangiographic groups, respectively. Associated pain was present in 50% and 36% of the swollen limbs in the abnormal and normal lymphangiographic groups. Pain relief (≥3 visual analog scale) at 40 months was 87% and 83%, respectively (P = .3), with 65% and 71%, experiencing complete pain relief. Quality of life criteria improved after stent placement in both groups but to a better extent in the normal lymphangiographic group. Abnormal lymphangiography improved or normalized in 9 of 36 (25%) of those tested after stent correction. CONCLUSIONS: Prevailing practice patterns and diagnostic deficiencies probably result in the misdiagnosis of many cases of venous lymphedema as "primary" lymphedema. IVUS is recommended to rule out venous obstruction as the associated or initiating cause of lymphedema. Iliac venous stenting to correct the obstruction has excellent long-term patency and good clinical outcome, although results are not as good as in those with normal lymphatic function.

An overview of in-stent restenosis in iliofemoral venous stents.

BACKGROUND: Although endovenous stents have been associated with overall low morbidity, they can require reinterventions to correct stent malfunction due to in-stent restenosis (ISR). ISR has often occurred iliofemoral venous stents but has not been well described. It has been reported to develop in >70% of patients who have undergone iliofemoral venous stenting. We sought to provide an overview of ISR in iliofemoral venous stents, including the pathologic, diagnostic, and management considerations and the identification of several areas of potential research in the future. METHODS: A search of reported English-language studies was performed in PubMed and the Cochrane Library. "In-stent restenosis," "vein," "venous," "iliac," and "iliofemoral" were used as keywords. The pertinent reports included in the present review had addressed the pathology, diagnosis, and current management options for ISR. RESULTS: ISR refers to the narrowing of the luminal caliber of the stent owing to the development of stenosis inside the stent itself. ISR should be differentiated from stent compression. Two main types of ISR have been described: soft and hard lesions. These lesions respond differently to angioplasty. Stent inflow and shear stress are important factors in the development of ISR. The treatment options available at present include balloon angioplasty (hyperdilation or isodilation), laser ablation, atherectomy, and Z-stent placement. CONCLUSIONS: Reintervention for ISR should be determined by the presence of residual or recurrent symptoms and not simply by a numeric value obtained from an imaging study. Overall stent occlusion due to ISR is rare, and no role exists for prophylactic angioplasty to treat asymptomatic ISR. The current treatment options for ISR are mostly durable and effective. However, more research is needed on methods to prevent the development of ISR. The role of antiplatelet and anticoagulant agents in the prevention of ISR requires further investigation, with particular attention to unique subset of patients (after thrombosis vs nonthrombotic iliac vein lesions). For high-risk, post-thrombotic patients, anticoagulation can be considered to prevent ISR. The role of triple therapy (anticoagulation and dual antiplatelet therapy) in the prevention of ISR remains unclear.

Iliofemoral venous configurations from three-dimensional computed tomography venogram and their relevance to stent design.

OBJECTIVE: Iliofemoral venous stenting has become the standard of care for patients presenting with quality-of-life impairing symptoms of chronic iliofemoral venous obstruction not responding to conservative measures. This has led to an increased use of venous stenting over the last several years. However, iliofemoral venous anatomy in patients requiring such intervention remains poorly elucidated. This study attempts to fill that gap. METHODS: Twenty-two consecutive patients with intravascular ultrasound examination-confirmed chronic iliofemoral venous obstruction underwent three-dimensional reconstruction of their computed tomography venogram images. Relevant angles, tortuosity (tort index-ratio between centerline length, and straight line length), lengths, and diameters were computed and analyzed. We used t tests for comparisons between the right and left sides. A P value of .05 or less was considered significant. RESULTS: Of the angles calculated, the median of the angles between the horizontal and common iliac vein (CIV) was 66° on the right and 60° on the left (P < .01). The median inferior vena cava-CIV angle was 172° on the right and 165° on the left (P < .0001). The CIV-EIV angle was 159° on the right and 151° on the L (P = .01). Overall, the median tortuosity was 1.07 on the right and 1.12 on the left (P = .007). The median centerline length of the CIV was 42mm on the right and 60mm on the left (P < .0001). The median external iliac vein length was 73 mm on the right and 88 mm on the left (P < .0001). The overall median iliac vein length was 220 mm on the right and 237 mm on the left (P < .01). The median diameters of the inferior vena cava at the iliocaval confluence, 20, 40, and 60 mm cranial to the confluence, were 23, 20, 22, and 23 mm, respectively. CONCLUSIONS: Overall, the left side has steeper angles, greater tortuosity, and longer lengths than the right side. These disparities should be considered during femoroiliocaval stent construction.

Percutaneous laser recanalization in chronically occluded iliofemoral venous stents.

Occlusion is a challenging complication of endovenous stenting. The treatment of chronic iliofemoral stent occlusion involves wire recanalization followed by balloon angioplasty. However, this approach will not always be successful. To treat such cases, we have successfully used a laser recanalization technique in 34 limbs (31 patients). This technique involved the use of a laser to first create a channel through the chronically occluded stent, followed by balloon angioplasty to improve the caliber of this recanalized tract. The mean age of the patients was 52 ± 13.6 years (range, 24-73 years). No adverse events related to the use of the laser occurred. Following laser recanalization, the venous clinical severity score had improved from 8.2 ± 4 to 5.1 ± 3.3 (P < .0001). The visual analog scale score for pain had improved from 7.8 ± 2.5 to 4.9 ± 3 (P = .0009). The grade of swelling had improved from 2.7 ± 1.3 to 1.6 ± 1.4 (P = .0001). At 12 months after intervention, the primary stent patency was 60% (standard error of the mean, 9.3%), and the secondary stent patency was 80%. Excimer laser recanalization of chronically occluded venous stents appears to be a rarely required but useful modality with reasonable clinical outcomes. Further reinterventions might be required to maintain long-term stent patency.

Effect of body mass index on initial presentation and outcomes after stenting for quality of life-impairing chronic iliofemoral venous obstruction.

OBJECTIVE: The incidence of obesity has been increasing, with recent data indicating that the age-adjusted mean body mass index (BMI) is close to 30 kg/m2 in the United States. Prior studies have raised concerns for an increased incidence of chronic venous insufficiency in the obese population. We aimed to build on current knowledge by assessing the effects of BMI on the initial presentation and outcomes after intravascular ultrasound (IVUS) luminal area-guided stenting in patients presenting with quality of life (QOL)-impairing chronic iliofemoral venous obstruction (CIVO). METHODS: A retrospective analysis of contemporaneously entered electronic medical record data on 464 continuous patients (464 limbs) with initial iliofemoral stents (2014-2017) for QOL-impairing CIVO was performed. The characteristics evaluated and compared included the degree of iliofemoral compression, CEAP (clinical, etiologic, anatomic, pathophysiologic) clinical class, venous clinical severity score (VCSS), grade of swelling (GOS), visual analog scale (VAS) for pain score, ulcer healing, reflux (venous segmental disease score; venous filling index-90), calf pump function (ejection fraction; residual volume fraction), and quality of life (CIVIQ-20 [chronic lower limb venous insufficiency 20-item questionnaire]) for those with a BMI <30 kg/m2 (group I) and a BMI ≥30 kg/m2 (group II). Paired and unpaired t tests were used for comparisons of the clinical variables and a Kaplan-Meier analysis was used to evaluate stent patency. RESULTS: Of the 464 limbs in the study cohort, 122 were in group I and 342 in group II. The median BMI was 26.3 kg/m2 (interquartile range, 19.6-29.9 kg/m2) in group I and 38.9 kg/m2 (interquartile range, 30.0-66.9 kg/m2) in group II. The IVUS luminal area-determined degree of compression was higher in group I than in group II across the common iliac, external iliac, and common femoral segments (P < .01). The supine foot venous and femoral venous pressures were higher in group II than in group I (P < .001). The ejection fraction was higher (57.4% vs 45.6%; P = .0008) and residual volume fraction was lower (27.5% vs 40.5%; P = .0008) in group II than in group I. Although the baseline VCSS and GOS were lower in group I than in group II (P < .05), no differences were found in the VAS for pain scores or ulcer prevalence. The median follow-up was 22 months. At 24 months after stenting, improvement was found in the VCSS, GOS, and VAS for pain score in both groups. The CIVIQ-20 QOL score had improved from 58.1 to 18.8 in group I (P = .0002) and from 60 to 37.5 in group II (P < .0001). At 5 years, primary patency was 70% in group I and 73% in group II (P = .6) and primary assisted patency was 100% in both groups (P = .99) without a significant difference in the reintervention rate (P = .5). CONCLUSIONS: Obese patients with CIVO-impairing QOL have a lesser degree of iliofemoral venous stenosis, more severe venous hypertension, and better calf pump function than their nonobese counterparts. After stenting, no differences were found in the clinical, stent patency, or QOL-related outcomes between the two groups.