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.

Improvement following restoration of inline flow argues against comprehensive thrombus removal strategies and for selective stenting in acute symptomatic iliofemoral venous thrombosis.

OBJECTIVE: Randomized trials have demonstrated the benefit of thrombus removal strategies in iliofemoral deep venous thrombosis (IFDVT) in providing early symptom relief and decreasing the incidence of post-thrombotic syndrome (PTS), especially severe PTS. However, the impact of quantum of residual thrombus burden (RTB) on PTS as determined by intravascular ultrasound examination and the role of venous stenting in the acute setting have not been evaluated and represent the focus of this study. METHODS: Sixty-nine limbs (65 patients) undergoing thrombus removal for acute symptomatic IFDVT between 2015 and 2021 formed the study cohort. The Venous Clinical Severity Score (VCSS) (range, 0-27) grade of swelling (GOS) (range, 0-4), and visual analog scale (VAS) pain scores (range, 0-10) were evaluated initially and at 6, 12, and 24 months after thrombus removal. Quality of life was appraised using the CIVIQ-20 instrument. The extent of initial and RTB after the intervention was estimated using intravascular ultrasound examination. Grading was done as less than 50% (1), 50% to 99% (2), or 100% (3) of luminal thrombus fill within each segment (common femoral vein, external iliac vein, and common iliac vein) by a blinded rater and then combined to generate a total score. The use of stenting, both concurrent (severe residual stenosis/persistent occlusion) and delayed (quality of life impairing residual or recurrent symptoms), was evaluated. RESULTS: Of the 69 limbs, 53 underwent pharmacomechanical/mechanical thrombectomy (PMT), whereas 16 patients underwent PMT and catheter-directed thrombolysis with restoration of inline flow in all limbs. Post-intervention VCSS improved from 6 to 2 at 24 months (P < .0001). GOS improved from 4 to 0 at 24 months (P < .0001). The VAS pain score went from 5 to 0 at 6 months (P < .0001) and remained at 0 at 12 months (P < .0001), but increased to 3 at 24 months (P = .02). The CIVIQ-20 score improved from 38 to 22 (P = .001) over a median follow-up of 19 months. The median RTB total score improved from 9 to 4 (P < .0001). There was no impact of RTB total score (<3 vs >3) on VCSS (P = NS), GOS (P = NS), VAS pain score (P = NS) or CIVIQ-20 score (P = NS) at the various time points. Concurrent stenting was used in 23 limbs (33%) and delayed stenting was carried out in 10 limbs (14%). The median time to delayed stenting was 4 months after the initial thrombus removal intervention. CONCLUSIONS: In patients undergoing PMT or PMT with catheter-directed thrombolysis for acute symptomatic IFDVT, the restoration of inline flow seems to be adequate to provide symptom relief and decrease the incidence of PTS. The extent of RTB does not seem to impact the VCSS, GOS, VAS pain score, or quality of life after such restoration. Stenting can be pursued selectively in the acute setting to help restore inline flow.

A unique complication of double barrel Wallstent technique in iliac-caval stenting.

The "double barrel" technique has been a popular option in reconstituting the iliac-caval confluence in bilateral stenting. It has been mostly used with the Wallstent (Boston Scientific, Marlborough, Mass). The technique, although generally trouble-free, has a unique long-term complication. One stent barrel was found to compress the other from a late developing compliance mismatch. The complication is easily missed unless an intravascular ultrasound examination is performed. A cross-fenestration between the two barrels supported by a Z stent might provide clinical relief if the double barrel extension into the vena cava is relatively short in length.

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.

Long-term outcomes following use of a composite Wallstent-Z stent approach to iliofemoral venous stenting.

OBJECTIVE: An endovascular approach has essentially replaced open surgery in the management of symptomatic chronic obstructive iliofemoral venous disease. In the last several years, such a minimally invasive approach has shifted from use of Wallstents alone to a combination of Wallstent-Z stent (composite stenting) to better deal with the iliocaval confluence. This study evaluates the clinical and stent related outcomes following use of composite stenting. METHODS: A retrospective review of contemporaneously entered EMR data on 535 patients (545 limbs) with initial iliofemoral stents placed over a 4-year period from 2014 to 2017 for symptomatic chronic iliofemoral venous obstruction was performed. Patients who underwent stenting after intervention for acute deep venous thrombosis were excluded. The impact of stenting on clinical outcomes before and after the intervention were evaluated through use of the visual analog scale pain score (0-10), grade of swelling (0-4), and Venous Clinical Severity Score (0-27). Quality of life was appraised using the Chronic Venous Disease quality of life Questionnaire 20 instrument. Kaplan-Meier analysis was used to assess primary, primary assisted and secondary stent patencies, and paired and unpaired t-tests were used to examine clinical outcomes. RESULTS: Of the 545 limbs that underwent stenting, 183 were in men and 362 were in women. The median age was 60 years. Laterality was right in 205 limbs and left in 340 limbs. Post-thrombotic syndrome was seen in 441 limbs and nonthrombotic iliac vein lesions/May-Thurner syndrome in 104 limbs. At 24 months, visual analog scale pain score went from 5 to 2 (P < .0001), grade of swelling went from 3 to 1 (P < .0001), and Venous Clinical Severity Score went from 6 to 4 (P < .0001). Ulcers were present in 67 limbs and had healed in 49 limbs (73%) over a median follow-up of 26 months. Global Chronic Venous Disease quality of life Questionnaire scores improved from 60 to 36 (P < .0001) after stenting. Cumulative primary, primary-assisted, and secondary patencies at 60 months were 70%, 99% and 91%, respectively. Thirty limbs (5.5%) required contralateral stenting. There was only one instance (0.2%) of contralateral iliofemoral deep venous thrombosis. One hundred eleven limbs (20%) underwent reintervention, including for in-stent restenosis in 44 limbs, stent compression in 2 limbs, in-stent restenosis and stent compression in 48 limbs, and stent occlusion in 17 limbs. CONCLUSIONS: In patients undergoing iliofemoral venous stenting for obstructive disease, clinical improvement, quality of life improvement, and stent patencies after use of a composite stent configuration are comparable with those seen after exclusive use of Wallstents. However, the use of a composite stent configuration not only decreases the need for contralateral stenting to relieve chronic obstruction, but also decreases the incidence of contralateral iliofemoral deep venous thrombosis.

An alternative explanation for the phasic variations in venous flow.

BACKGROUND: Phasic venous flow variation with respiration is surrounded by controversy and not well understood. The current concept assigns a major role to the "abdominal pump." According to this model, inspiratory increases in abdominal pressure compress the vena cava, increasing its internal venous pressure and propelling blood upstream. Some have assigned a secondary role to the "thoracic pump," with the negative intrapleural pressure aiding blood flow toward the heart. The aim of the present study was to examine the phasic changes in flow, pressure, and volume in the central veins and named tributaries. METHODS: Caliber area changes were measured using intravascular ultrasonography in 37 patients undergoing iliac vein stenting. The pressure was measured in 48 patients using transducer tip catheters with electronic zero calibration. Duplex ultrasound flow in the head and neck and truncal and limb veins during inspiration and expiration was measured in 15 normal volunteers. RESULTS: The caliber of the abdominal inferior vena cava had increased by 32% and its lateral pressure had decreased significantly during inspiration. Intravenous pressure in the central veins of the chest and right atrium was positive at 6 to 14 mm Hg. Negative pressures were rarely seen and then only transiently. The internal jugular vein displayed little phasic variation. The upper limb veins displayed weak inspiratory phasicity. Phase polarity was reversed in the lower limbs, with near flow stoppage during inspiration. CONCLUSIONS: These observations conflict with the current notions of venous flow phasicity, which are based on push-pull pressure changes in the abdominal and thoracic veins. The paradoxical inspiratory inferior vena cava caliber increase probably explains the concurrent pressure decrease. Sustained negative pressures in the thoracic central veins and right atrium did not occur. We have proposed an alternate hypothesis for venous flow phasicity based on alternate stretching and relaxation of the mobile section of the great veins with respiratory movement.

Experimental analysis of aspect ratio in iliac vein stenosis.

BACKGROUND: Veins are thin-walled tubes. Their lumen is roughly circular with an aspect ratio close to 1:1 under physiologic pressures. When they collapse owing to decreased internal pressure or external compression, the aspect ratio changes. The vertical diameter is usually diminished more than the transverse, with a considerable decrease in the lumen area. The recent emergence of stent correction of many venous compression syndromes, particularly iliac vein stenosis, has brought attention to the importance of the aspect ratio, quite apart from an overall decrease in caliber. The iliac vein pressure is influenced not only by stenosis, but also intra-abdominal pressure, right atrial pressure, and collaterals. We investigated the impact of aspect ratio in an experimental model incorporating these factors. METHODS: Inflow was provided from a header tank at 25 mm Hg pressure into a Penrose tubing enclosed in a polyethylene cylinder pressurized (Starling pressure) to simulate intra-abdominal pressures of 5 and 10 mm Hg. The Penrose drained into an outflow tank with a pressure of 7 mm Hg, simulating right atrial pressure. Stenosis was simulated with a series of three-dimensional, printed plastic nozzles with caliber areas of 50, 100, and 200 mm2 and varying in aspect ratios of 1:1 to 1:4. The flow and pressure in this system was monitored with the use of overflow collaterals in some experiments. RESULTS: Free flow from the header tank through the Penrose (zero Starling pressure) with a 200 mm2 circle nozzle into the outflow tank with zero pressure resulted in flow pressure of approximately 1.5 mm Hg. Using nozzles of a smaller caliber or an increased aspect ratio resulted in an increase of flow pressures of up to approximately 3.7 mm Hg. Flow into an outflow tank of 7 mm Hg simulating right atrial pressure further increased flow pressures by approximately 7 mm Hg. The addition of Starling pressures of 5 and 10 mm Hg simulating abdominal pressure increased flow pressure even further to the 10 to 17 mm Hg range. When the Starling pressure was dominant, the additional contribution of nozzle caliber stenosis or aspect ratio reduction to the overall flow pressure ranged from 2 to 6 mm Hg. Collateral overflow varied inversely with collateral resistance. Some experiments yielded an anomalous flow/pressure phenomena known to occur in collapsible tube flows. CONCLUSIONS: A decrease in the caliber or the aspect ratio of iliac vein stenosis was among several other factors that generate peripheral venous hypertension in an experimental model. Increased intra-abdominal pressure is a major influence that amplifies the pressure effects of aspect ratio or caliber reduction.

The two-segment caliber method of diagnosing iliac vein stenosis on routine computed tomography with contrast enhancement.

BACKGROUND: Iliac vein stenosis is a frequent pathologic process in advanced chronic venous disease. Intravascular ultrasound (IVUS) has emerged as the "gold standard" to diagnose iliac vein stenosis and to guide stent treatment. A pre-IVUS test is often obtained. Routine venography is deficient in several respects to fill this role; absence of an internal scale is a critical deficiency. Computed tomography venography (CTV) may be superior; its measurement capabilities can be used to precisely identify stenotic iliac vein caliber. Furthermore, the calibers of common iliac vein (CIV) and external iliac vein (EIV) can be individually assessed, yielding two data points instead of single-point assessment used in venography and current CTV protocols. We compared the diagnostic accuracy of the two-segment caliber method of CTV (arm vein injection of contrast material) with IVUS. METHODS: In patients who underwent computed tomography assessment of iliac vein segments before IVUS examination during a 5-year period, 91 limbs were analyzed. This is a single-center, retrospective analysis of prospectively collected data. CTV images of CIV and EIV segments were compared individually and in combination with IVUS planimetry images. A caliber diameter of <16 mm for CIV and <14 mm for EIV was considered stenotic with either imaging technique. Bland-Altman plots and receiver operating characteristic curves were used. RESULTS: On IVUS evaluation, 84% of CIVs and 78% of EIVs were stenotic and 16% and 22% were of normal caliber. These provided IVUS positive and negative controls for CTV comparison. On CTV, at least one of the two segments (CIV or EIV) was stenotic in 90% of the limbs, about 10% to 15% higher than single-segment involvement. Mean CTV caliber difference from IVUS was +2.5% for CIV and +7.3% for EIV. On Bland-Altman plot, single-segment diagnostic sensitivity of CTV was 83% and 73% for CIV and EIV, respectively, compared with IVUS. The sensitivity increased to 97% with a positive predictive value and accuracy of 93% and 91%, respectively, when a stenotic caliber in at least one of the two segments was considered diagnostic of iliac vein stenosis. Receiver operating characteristic analysis confirmed increased accuracy of the two-segment method over single-segment assessment with an area under the curve of 0.89 (P < .001). CONCLUSIONS: Caliber diameter of <16 mm for CIV or <14 mm for EIV on routine CTV imaging appears to correlate with IVUS caliber stenosis with good diagnostic metrics of low false positives and false negatives.