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J Vasc Interv Radiol 2009 Smouse-1

J Vasc Interv Radiol 2009 Smouse-1
J Vasc Interv Radiol 2009 Smouse-1

Deployment Performance and Retrievability of the Cook Celect Vena Cava Filter

H.Bob Smouse,MD,William G.Van Alstine,DVM,PhD,Susan Mack,BS,and Jennifer A.McCann-Brown,PhD

PURPOSE:To test the safety,performance,and retrievability of the Cook Celect vena cava filter.

MATERIALS AND METHODS:Twenty female or castrated male sheep were implanted with two Celect filters in series,in the inferior vena cava.The animals were divided into five groups of four animals according to day of filter retrieval.Filter retrieval occurred at approximately30,60,90,180,and360days after implantation.At each time point, two sheep underwent retrieval attempts of both the cranial and caudal filters.These animals were recovered for30 days,at which time healing was assessed.In two additional sheep at each time point,retrieval of only the cranial filter was attempted and the caudal filter was left in situ.These sheep were euthanized after retrieval,and the segment of vena cava encompassing the sites of both the retrieved filter and the filter left in situ was excised for gross and histopathologic analysis.

RESULTS:Retrieval attempts occurred at34,62,90,188,and393days after implantation.All retrievals were successful (30of30).Tilt was detected in eight filters at implantation;six had self-centered before retrieval.At retrieval,no filter migration or deformation was reported.All filters were retrieved with acceptable levels of force.At each time point,there was evidence of mild intimal hyperplasia at the filter anchoring sites and no evidence of vena cava injury.

CONCLUSIONS:The Celect vena cava filter was safely used as a retrievable filter for up to393days in an ovine model. J Vasc Interv Radiol2009;20:375–383

Abbreviation:IVC?inferior vena cava

INFERIOR vena cava(IVC)filters are used to treat patients with,or at a high risk for developing,pulmonary embo-lism.Patients with a high risk for pul-monary embolism include those with deep vein thrombosis,those undergoing surgical procedures requiring prolonged

bed rest,those with a history of pul-

monary embolism,and trauma pa-

tients(1,2).IVC filters are classified

according to the intended duration of

implantation as permanent,tempo-

rary,or retrievable/optional(3–5).Re-

trievable/optional filters are unique

because they may be used as perma-

nent or retrievable devices.The in-

dwell period for retrievable filters is

patient-specific and based on the indi-

cation for device placement and an

evaluation of continued clinical bene-

fit provided by the device at follow-

up.Currently,there are four IVC fil-

ters available for retrievable use in the

United States:the OptEase filter(Cor-

dis Endovascular,Miami Lakes,Flor-

ida),Recovery G2filter(Bard Peripheral

Vascular,Tempe,Arizona),Gu¨nther

Tulip filter(Cook,Bloomington,Indi-

ana),and Celect filter(Cook).These

devices have had much clinical suc-

cess;however,long-term retrievals are

often challenging.

The design of the Celect filter is

based on the Gu¨nther Tulip vena cava

filter(both manufactured by William

Cook Europe,ApS Bjaeverskov,Den-

mark and sold by Cook).The safety

and effectiveness of the Gu¨nther Tulip

vena cava filter is supported by a large

body of pre-clinical and clinical data,

which have demonstrated that the

Gu¨nther Tulip can be safely retrieved

or can be left in place as a permanent

implant when clinically indicated

(3,6–11).Design modifications associ-

ated with the Celect filter were in-

tended to improve retrieval success

and reduce the incidence of difficulties

associated with retrieval at longer in-

dwell times.The current study was

designed to assess the safety,perfor-

mance,and retrievability of the Celect

filter at time points up to360days

after implantation in an ovine model.

From OSF St.Francis Medical Center,Peoria,Illi-

nois(H.B.S.);Purdue University,West Lafayette,

Indiana(W.G.V.A.);and MED Institute,Inc,1

Geddes Way,West Lafayette,IN47906(S.M.,

J.A.M.B.).Received March28,2008;final revision re-

ceived November26,2008;accepted December6,2008.

Address correspondence to J.A.M.B.;E-mail:Brown@

https://www.wendangku.net/doc/8f17072926.html,

H.B.S.serves as a paid consultant to Cook,Inc.

W.G.V.A.serves as a paid consultant to MED Insti-

tute,Inc,a Cook Group company.S.M.is an em-

ployee of MED Institute,Inc,a Cook Group com-

pany.She is a salaried employee of the company.

J.A.M.B.is an employee of MED Institute,Inc,a

Cook Group company.She is a salaried employee of

the company.

?SIR,2009

DOI:10.1016/j.jvir.2008.12.406

Laboratory Investigations

375

MATERIALS AND METHODS

Device

The design of the Celect vena cava filter is based on that of the Gu ¨nther Tulip vena cava filter (Fig 1).Both filters are made from cobalt chromium,are magnetic resonance-imaging compati-ble,and have the same overall conical shape and total number of legs.The Celect filter has four primary legs and eight secondary legs.The four primary legs are made from 0.018-inch-diameter https://www.wendangku.net/doc/8f17072926.html,pared with the Gu ¨nther Tu-lip,the curvature of the primary legs has been modified slightly to improve an-choring in the vena cava.Unlike the Gu ¨nther Tulip,the distal end of the eight secondary legs of the Celect filter (made from 0.010-inch-diameter wire)do not connect to the primary legs.Along its main axis,the Celect filter measures 46mm (from the filter hook to the distal end of the primary leg),and it is capable of radial expansion up to 32mm.Like the Gu ¨nther Tulip,the Celect filter contains a ball-tipped atraumatic hook that can be snared to accomplish repositioning or retrieval with a jugular approach.The Gu ¨nther Tulip vena cava in-troducer set and retrieval set (Wil-liam Cook Europe)were used for fil-ter placement and retrieval.The introducer set consists of an 8.5-F co-axial introduction sheath with a ra-diopaque marker band.The retrieval set consists of a retrieval snare and an 11-F sheath.

Study Population

Twenty female or castrated male ju-venile sheep weighing 54–75kg were used for this study.All animals were housed and examined in compliance with the National Institutes of Health Guide for Care and Use of Laboratory Animals (NIH publication 86-23)and ISO 10993-2animal welfare require-ments.This study adhered to good laboratory practices guidelines.

Animals were obtained from a li-censed vendor.The vendor assigned unique,nonconsecutive numbers to each animal,which were used to iden-tify animals throughout the study.All sheep were subjected to a 1-week quarantine and conditioning period in which they were screened for illness.The sheep were deprived of food for 24hours and water for approximately 8hours before filter implantation.Sheep were anesthetized with a stan-dard mixture of ketamine (Phoenix Scientific,St Joseph,Missouri),xyla-zine (Butler Animal Health,Dublin,Ohio),and butorphenol (Fort Dodge Animal Health,Overland Park,Kan-sas)and subsequently intubated for maintenance on gas anesthesia with isoflurane in oxygen (Abbott Labora-tories,Chicago,Illinois).Filter implan-tation was conducted under general anesthesia with electrocardiographic monitoring.Surgical procedures were performed by using standard veteri-nary surgical practices and aseptic technique.Once the implantation pro-cedure was completed and the animal had fully recovered from anesthesia,

food and water were provided ad libi-tum.The animals did not receive anti-coagulants at any point during this study.

Filter Deployment

Sheep were placed into five groups according to the time of filter retrieval (ie,approximately 30,60,90,180,and 360days after implantation);there were four animals in each group.Each animal received two Celect vena cava filters in series in the IVC,for a total of 40filters.All filters were placed in the IVC by percutaneous access to the jugular vein by using a modified Seldinger technique and the Gu ¨nther Tulip jugular intro-ducer set.A 0.035-inch wire guide was advanced into the vena cava via the jug-ular vein.A vessel-sizing catheter was introduced over the wire under fluoro-scopic guidance.The wire guide was removed and the catheter connected to a power injector.A power contrast injec-tion (?40mL at ?20mL/sec)was used to obtain venograms in both anteropos-terior and oblique views.These images were used to measure and select filter placement sites where the vena cava di-ameter was between 15and 30mm.In the event that a filter leg was uninten-tionally deployed into a venule or side branch (sheep vena cava have many,and these are difficult to identify at venography because of valve flaps that cover the ostia at the terminus with the IVC),the filter was repositioned so that all filter legs were within the vena cava.During each procedure,the perfor-mance of the deployment system was subjectively evaluated (failure,very poor,poor,adequate,good,very good,or excellent)in terms of the following characteristics:preparation,introduc-tion,pushability,trackabilty,flexibility,positioning,deployment,and filter ra-diopacity.After deployment,venograms were obtained in anteroposterior and oblique views to assess filter tilt,mi-gration,and configuration (ie,defor-mation,symmetry of filter legs,en-tanglement,bending).A filter was considered to be free of tilt if it ap-peared centered in both views.Mi-gration was assessed by using ana-tomic landmarks (ie,vertebral spaces and vertebral bodies).After the placement procedure,filter reposi-tioning was not

permitted.

Figure https://www.wendangku.net/doc/8f17072926.html,parison of the Gu ¨nther Tulip vena cava filter (left)and the newer Celect vena cava filter (right).

376

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Deployment and Retrievability of the Celect Filter

March 2009JVIR

Filter Retrieval

The Gu ¨nther Tulip vena cava filter retrieval set was used to retrieve all filters via jugular access.Procedures were performed by an experienced in-terventional radiologist (H.B.S.).At re-trieval,two venograms (obtained with the same technique used during filter deployment)in orthogonal projections were obtained to evaluate filter tilt,migration,configuration,evidence of thrombus,and changes in the vena cava diameter.The degree of difficulty associated with retrieval (no difficulty,average,above average [acceptable],or high difficulty [unacceptable]),the required retrieval force (below aver-age,average,above average [accept-able],or above average [unaccept-able]),and the ability of the retrieval snare to engage the filter hook (yes or no)were also assessed by the interven-tionalist.These assessments were based on the interventional radiologist’s many years of clinical experience in the place-ment and retrieval of vena cava filters.The use of excessive retrieval force was not permitted.Migration occur-ring in the interval between filter placement and retrieval was assessed by comparing the relationship of the filter with the anatomic landmarks on venograms collected at implantation to those collected before retrieval.Four sheep were assessed at each time point (ie,approximately 30,60,90,180,and 360days after implanta-tion).In two sheep at each time point,the cranial filters were retrieved while the caudal filters were left in situ.These

sheep were euthanized immediately af-ter retrieval to assess acute IVC damage after the retrieval attempt and to assess healing at the placement site of the fil-ter remaining in situ.In the two re-maining sheep,the cranial and caudal filters were both retrieved.These sheep recovered for approximately 30days and then were euthanized to evaluate healing at the vena cava re-trieval site.Thus,six filter retrieval at-tempts were made at each follow-up time point (Table 1).

Vena cava segments with filters left in situ were closely examined to assess filter placement in the vessel,the dis-tribution of filter legs,and filter expan-sion.High-resolution radiographs of these segments were obtained before histologic processing to evaluate filter conformation and filter fracture.All retrieved filters were examined grossly and under a dissecting microscope (mag-nified up to ?100)to assess general filter conformation and evidence of corrosion or fracture.Histologic Evaluation

The acute and chronic effects of the retrieval procedure on the vena cava wall were evaluated through gross and histopathologic examination.For each group of animals,histologic eval-uation was conducted on four sites (two filter sites in each of two animals,including one site from which a filter had been retrieved and one site in which a filter was left in situ)immedi-ately after sacrifice and on four sites (two filter sites from which filters had

been retrieved in each of two animals)after a 30-day recovery period.

Vein segments with filters in situ were embedded in methylmethacrylate plastic with the filter in place before sec-tioning and staining.Vein segments at filter retrieval sites underwent standard paraffin histologic processing.Thin sec-tions of these segments were stained with hematoxylin and eosin and exam-ined by an independent board-certified experienced veterinary pathologist (W.G.V.A.).Each sample was evaluated for IVC wall response to filter implanta-tion and retrieval,including an evalua-tion of vessel wall injury (ie,perforation,hematoma,thrombus,and penetration)and an assessment of inflammatory or foreign body responses at the filter an-choring sites and sites of maximum ex-pansion of the secondary legs.Gross Pathology

After sacrifice,gross necropsy of each sheep was conducted to assess for regional and systemic abnormalities.Evaluation included the integumentary,musculoskeletal,respiratory,cardiovas-cular,digestive,genitourinary,lym-phatic,endocrine,and nervous systems.

RESULTS

Filter Placement

All 40Celect vena cava filters (two in each animal)were successfully placed.The overall performance of the deployment system was regarded as very good or excellent for all deploy-

Table 1

Overview of Study Design,Retrieval Time,and Day of Follow-up Group No.of Sheep Day of Filter Retrieval

Day of Sacrifice Filters Retrieved Filters Left In Situ Retrieval Success 1234342cranial 2caudal 100%234642cranial,2caudal 0

2262622cranial 2caudal 100%262922cranial,2caudal 0

3290902cranial 2caudal 100%2901202cranial,2caudal 0

421881881cranial,1caudal*1caudal,1cranial 100%21882162cranial,2caudal 0

5

23933932cranial 2caudal 100%

2

393

426?

2

cranial,

2caudal

*Due to an abscess in one sheep in this group,a cranial filter was left in situ and the caudal filter retrieved.

?One animal died 5days before its scheduled sacrifice.Histopathologic assessment of the vena cava from this animal occurred at day 421.

Smouse et al

?

377

Volume 20Number 3

ments.Data about filter tilt at implan-tation are presented in Table2;eight of the40filters(20%)were tilted at implantation.Additional details asso-ciated with filter implantation are as follows.

Group1(30-day implant).—Two of eight filters required several deploy-ment attempts to achieve placement in the desired location(ie,without legs in a side branch),but all were success-fully implanted and the overall perfor-mance of the deployment system was still regarded as very good(note that the deployment system is specifically designed to allow capture and release of the filter until optimal placement is achieved).No evidence of tilt,migra-tion,or deformation was detected at implantation in any filter.

Group2(60-day implant).—All eight filters were successfully placed,al-though nine filters were required to achieve these placements.A second-ary leg of one caudal filter was de-formed(ie,bent)as a result of multiple deployment attempts(one leg of the filter landed in a side branch and the filter was recaptured,resheathed,and redeployed twice)and was subse-quently replaced with a new filter.In addition,more than one attempt was required to release one of the filters from the deployment system.Tilt was observed in two filters after placement (Table2).In one case,tilt was caused by contact with the sizing catheter during post-deployment venography and was therefore attributed to opera-tor error.Filter deformation(ie,bend-ing)at the secondary leg occurred in two cranial filters during implanta-tion.These deformations were caused by a failure to use the protective peel-away sheaths when passing the filters into the delivery sheaths,through the hemostatic valves;this was regarded as operator error and not a complica-

tion of the deployment procedure.

Subsequently,peel-away sheaths were

used for all filter placements;no addi-

tional deformations were observed.

No migration was detected after filter

implantation.

Group3(90-day implant).—All eight

filters were successfully implanted,al-

though ten were necessary to com-

plete placements in this group.De-

ployment difficulties occurred in two

attempts.In one case,a filter was in-

advertently placed in a side branch.

During an attempt to retrieve the fil-

ter,it was accidentally released from

the snare and became lodged in the

retrieval sheath;the retrieval system

and filter were removed together and

a replacement filter was successfully im-

planted.In another case,the filter

could not be placed due to resistance

from a curve in the delivery sheath as

it entered the vein;repositioning of the

sheath alleviated the resistance.How-

ever,the placement attempt resulted

in deformation(ie,bending)of a sec-

ondary leg;therefore,the filter was

replaced.Despite these difficulties,the

overall system performance was still

regarded as excellent.Tilt was ob-

served in two of eight filters after im-

plantation(Table2).There was no ev-

idence of migration or deformation

with any filter at implantation.

Group4(180-day implant).—All eight

filters were successfully placed.One

of eight filters was tilted after im-

plantation(Table2).No migration or

filter deformation was observed after

implantation.

Group5(360-day implant).—All eight

filters were successfully placed.Three

of eight filters were tilted after implan-

tation(Table2).One filter was tilted

immediately upon implantation due

to accidental contact with the deploy-

ment system.However,this contact

was regarded as operator error and

not a complication of the deployment

procedure.One filter exhibited un-

even distribution of secondary legs;

this may have been the result of the

anatomy of the vena cava at the loca-

tion in which a secondary leg came

into contact with the caval wall.Be-

cause numerous small venules empty

into the vena cava in this region,the

secondary leg may have become en-

gaged in the ostia of a venule.No filter

migration was observed in this group.

Filter Retrieval

Retrieval attempts took place at34,

62,90,188,and393days after implan-

tation(Table1).Details of filter tilt at

retrieval are provided in Table2;three

of40filters(7.5%)were tilted at re-

trieval.All retrieval attempts(30of30)

were successful,and the force re-

quired for retrieval in each instance

was acceptable(Table3).Inspection of

the in situ filters revealed no deforma-

tion(eg,bending)or fracture at any

time point.Similarly,evaluation of the

retrieved filters revealed no fracture,

deformation,corrosion,or pitting;other

findings related to the retrieved filters

are described within the appropriate

group below.Evaluation of filter sites

indicated no evidence of vena cava in-

jury(ie,stenosis,ingrowth,perfora-

tion,hematoma,or thrombus)at any

cranial or caudal filter sites.Addi-

tional histopathologic findings associ-

ated with vena cava filter sites are pro-

vided in Table4.Finally,necropsy

performed on animals at each time

point indicated no filter-induced re-

gional or systemic changes.Results for

each retrieval time point are as fol-

lows.

Group1:filter retrieval34days after

Table2

Filter Tilt at Implantation and Retrieval

Tilt Angle

Group1(Day34)Group2(Day62)Group3(Day90)Group4(Day188)Group5(Day393) Implantation Retrieval Implantation Retrieval Implantation Retrieval Implantation Retrieval Implantation Retrieval

0°8867677758

?10°0000010020 10°–20°0010101100

?20°0011100010 Note.—Eight of the40filters(20%)were tilted at implantation,and three of the40(7.5%)were tilted at retrieval. 378?Deployment and Retrievability of the Celect Filter March2009JVIR

implantation.—Pre-retrieval venograms showed no evidence of filter tilt(Table 2),migration,or deformation.The fil-ters implanted in three of the four sheep showed no evidence of throm-bus or change in vena cava diameter. In the fourth animal,the quality of the venogram did not permit assessment of these characteristics.

Group2:filter retrieval62days after implantation.—Pre-retrieval venograms

showed that one of eight filters was

tilted(one of the same filters as at

implantation;Table2).The other filter

that was tilted at implantation had

self-centered by the time of retrieval.

Similarly,two of eight filters showed

evidence of deformation,as noted at

implantation.One retrieved filter had

a small piece of tissue attached to a

primary strut at the anchor.There was

no evidence of filter migration,throm-

bus in the vena cava,or change in

vena cava diameter.Five of six filter

hooks were reported as easy to engage

during the retrieval procedure.One

filter hook was initially difficult to en-

gage;in this instance,the retrieval

snare twisted during an attempt to re-

trieve a cranial filter.A new snare was

Table3

Force Required for Celect Filter Retrieval

Group Time of Filter

Retrieval(d)

Successful Retrievals

(n?6per Time Point)

Force Required for Retrieval

Below

Average Average

Above Average

(Acceptable)

Above Average

(Unacceptable)

13460420 26261320 39061230 418860330 539360240 Total no.of filters2(6.7%)14(47%)14(47%)0(0%)

Table4

Histologic Assessment of Filter Placement Sites

Group Days to

Retrieval

Retrieval Sites

Immediately

after Retrieval

Retrieval Sites

After the30-d

Recovery Period Sites with Filters in Situ

130 NA Localized hemorrhage at sites in1 Secondary legs not incor-

porated

Primary leg contact regions

embedded in neointimal

tissue layer

No inflammatory response

262 NA Minimal intimal fibrosis at primary

leg contact regions and regions of

secondary leg contact Secondary legs not incor-porated

Primary leg contact regions embedded in neointimal tissue layer

No inflammatory response

390 NA Minimal intimal fibrosis at primary

contact regions and regions of sec-

ondary leg contact Secondary legs not incor-porated

Primary leg contact regions embedded in neointimal tissue layer

No inflammatory response

4188 1of2had neointimal growth

at anchoring filter

1of2had minimal intimal

fibrosis at primary leg con-

tact regions and regions of

secondary leg contact 1of4had neointimal growth at

primary leg contact regions and/or

secondary leg contact regions

3of4had minimal intimal fibrosis

at primary leg contact regions and

secondary leg contact

1of2had minimal intimal

fibrosis at the primary leg

contact regions and sec-

ondary let contact regions

No inflammatory response

5393 2of2had minimal intimal

fibrosis at primary leg con-

tact regions and regions of

secondary leg contact Minimal intimal fibrosis at primary

leg contact regions and regions of

secondary leg contact

Minimal intimal fibrosis at

primary leg contact regions

and secondary leg contact

regions

No inflammatory response

Note.—NA?no additional significant findings.Smouse et al?379

Volume20Number3

used and the filter was retrieved successfully.

Group 3:filter retrieval 90days after implantation .—Pre-retrieval venograms showed that one of eight filters was tilted.The two filters that were tilted at implantation had self-centered by the time of retrieval (Table 2).There was no filter migration,evidence of thrombus in the vena cava,or changes in vena cava diameter.A small amount of tissue was found on each filter surround-ing or adjacent to where the struts connect to the bushing (Fig 2),but this tissue did not obstruct the retrieval hook.

Group 4:filter retrieval 188days after implantation .—Pre-retrieval venograms showed that one of eight filters was tilted (the same filter that was tilted at implantation).There was no evidence of filter migration.Filter deformation was observed in one cranial filter;al-though the legs of this filter were evenly distributed at implantation,an abscess had developed,which dis-placed some of the filter legs.No at-tempt was made to retrieve this cra-nial filter.In this case,this cranial filter was left in situ and the caudal filter was retrieved.It was determined that the abscess was due to an opportunis-tic infection with Corynebacterium pseu-dotuberculosis .The most likely expla-nation for the abscess was local vessel trauma resulting in injury and inflam-mation,which served as a nidus for colonization by this bacterium,a rec-ognized cause of progressively expan-sile abscesses in sheep with implanted devices.Therefore,this incident is not considered to be device-specific.

Group 5:filter retrieval 393days after implantation .—Pre-retrieval venograms showed no evidence of filter tilt,mi-gration,or deformation in any filter.The three filters that were tilted at im-plantation had all self-centered by the time of retrieval.All six retrievals were successful,although two of the filter snares did not open completely.Representative images of vena cava segments are provided in Figures 3and 4.As indicated by the gross image in Figure 3,there was no evidence of vena cava injury at the filter site.Fig-ure 4presents histologic images from the vena cava at both the cranial and caudal filter sites.Figures 4a and 4b are representative of normal vena cava regions associated with cranial filter retrieval.Figures 4c and 4d demon-strate that minimal fibrosis was ob-served near the anchor regions of a primary leg in a caudal filter while the secondary legs remained uncovered in the lumen.Finally,Figure 5is a repre-sentative image of intimal tissue ad-herent to a primary filter wire.Nec-ropsy revealed no filter-induced regional or systemic changes in any animal.One sheep in the retrieval-with-re-covery group died unexpectedly 5

days before its scheduled sacrifice.Necropsy indicated that the death re-sulted from an occlusive nasal carci-noma,leading to systemic hypoxia and a fatal arrhythmia.The death was not device-related.

DISCUSSION

IVC filters offer an alternative ther-apy for patients with contraindications to anticoagulation medications and those in whom anticoagulant therapy is unsuccessful (5).Permanent IVC fil-ters have been used clinically since the late 1960s (12,13).Retrievable filters have been available since 2003in the United States and are useful in pa-tients with a temporary need for IVC filtration,including trauma patients (2,14).Currently,four filters are cleared by the U.S.Food and Drug Administration for retrievable/optional use (the Gu ¨nther Tulip,OptEase,Re-covery G2,and Celect filters).Re-trieval of these devices after long in-dwell periods may be hindered by filter tilt and neointimal growth around the filter at either the retrieval hook/filter apex or anchoring legs (11,15–18).In fact,up to 11.7%of attempted filter retrievals are unsuccessful be-cause the filter is embedded in the IVC wall (18).

Techniques to safely extend the time to retrieval have been

sought

Figure 2.Representative Celect filter retrieved 90days after im-plantation.There was minimal evidence of adherent tissue near the filter bushing (arrows).(Available in color online at https://www.wendangku.net/doc/8f17072926.html,

.)Figure 3.Representative gross specimen of a sheep vena cava at the site from which a cranial filter had been retrieved 393days after implantation.There is no evidence of vessel wall perforation or

other substantial damage related to the presence of the filter.Ap-proximate cross sections for histopathologic examination are indi-cated at cranial anchor sites (solid lines)and at the secondary leg

contact region (dashed lines).AH ?acute adventitial hemorrhage due to excision,BV ?branch vessel,RB ?residual blood not washed out at tissue collection,RVF ?renal or hepatic vein with valve flap.(Available in color online at https://www.wendangku.net/doc/8f17072926.html, .)

380

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Deployment and Retrievability of the Celect Filter

March 2009JVIR

since retrievable filters were intro-duced.One strategy to extend the in-dwell period is to reposition a filter within the IVC every 10–14days (19–21).Although this method has re-sulted in extended indwell periods,there are increased risks associated with the required multiple invasive procedures.The Celect filter,which is based on the predicate Gu ¨nther Tulip filter,was designed to have an ex-tended period for successful filter re-trieval as compared to the Gu ¨nther Tulip filter.In the present study,Celect IVC filters were implanted in sheep for up to 393days to determine the success of filter retrieval after ex-tended implantation times.Results support the retrieval safety of the Celect filter,which may translate to clinical benefits for patients requiring long-term,but not permanent,filter placement.

The safety and effectiveness of the predicate Gu ¨nther Tulip filter has been widely studied.In foxhounds,the Gu ¨nther Tulip filter was safely re-trieved at time points up to 14days (22).In a porcine model,retrieval of Gu ¨nther Tulip filters was also easily achieved at times up to 14days but became progressively more difficult after 20days due to intimal prolifera-tion (23).In addition to these animal studies,clinical evidence has also demonstrated that the Gu ¨nther Tulip vena cava filter can be safely retrieved 10–14days after implantation (1,24–26).Although filter retrieval has been performed successfully at later time points,retrieval difficulty tends to in-crease over time.Many studies,how-ever,have demonstrated extended time to retrieval without filter reposi-tioning (6,8–10).Most recently,Smouse et al (11)reported on Gu ¨nther Tulip retrieval attempts in 275patients–the largest study reported to date.Two hundred forty-eight attempts were successful.Twelve weeks after im-plantation,the probability of a suc-cessful retrieval remained greater than 94%,and by 26weeks the probability of a successful retrieval was approxi-mately 67%.For patients requiring a shorter-term retrievable filter,the re-sults of that study are promising,al-though higher retrieval success rates at longer indwell times are still desir-able.

The Celect and Gu ¨nther Tulip fil-ters share most design features

and

Figure 4.(a)Photomicrograph (original magnification,?100)shows a representative normal region from which a cranial filter was retrieved 393days after implantation.The intimal layer is indicated by the dotted arrow and the tunica media by the solid arrow.(b)Photomicrograph (original magnification,?100)shows a representative normal re-gion of secondary leg contact after retrieval of a cranial filter 393days after implantation.Normal (solid arrow)and thickened (dotted arrow)intima are shown.(c)Photomicro-graph (original magnification,?40)shows a representative site of caudal anchor region 393days after implantation.A primary leg surrounded by fibrous tissue pushes the wall peripherally.Mature fibrovascular connective tissue (white arrow)fills in the gap be-tween the primary leg and the lumen.Intact,smooth muscle of the vein wall is indicated by the black arrow.The vein wall is compressed but intact with fibrous tissue and vascular smooth muscle abluminal to the primary leg anchor site.This is a typical and expected healing response.(d)Photomicrograph (original magnification,?100)shows a region of maximal expansion of secondary legs.Both primary and secondary legs were uncovered in the lumen.There is little to no reaction at the sites where the struts and wires contact the vessel wall.(Available in color online at https://www.wendangku.net/doc/8f17072926.html,

.)

Figure 5.Representative Celect filter retrieved 393days after implantation shown at the primary legs.There was minimal evidence of adherent tissue on a primary leg (arrow).

Smouse et al

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381

Volume 20Number 3

were therefore expected to have the same reliability in terms of pulmonary embolism prevention.In fact,an in vitro study(27)has demonstrated a similar embolus-capturing efficiency when comparing the Celect filter to the Gu¨nther Tulip filter.Design mod-ifications to the secondary legs of the Celect filter were intended to(a)yield a device with an increased ability to self-center in the vena cava,reducing the likelihood of filter tilt,and(b)re-duce the opportunity for filter entrap-ment by neointimal growth by elimi-nating places where secondary legs crossed over the primary legs.Ulti-mately,the Celect filter was designed to have an extended implant duration for safe filter retrievals.

The results of the present study in-dicate that deployment and retrievals were performed with minimal diffi-culty.The overall performance of the delivery system was regarded as very good or excellent for each group of animals.Three of the40filters(7.5%) were discarded and replaced because of deformations that occurred during deployment.Two of the40filters(5%) were easily recaptured and reposi-tioned after misplacement(ie,in a side branch)on the first deployment at-tempt.In each instance,the versatility of the deployment system allowed for filter manipulation without increased damage to the vessel wall.Further-more,the data support safe filter re-trievals(100%retrieval success rate)at extended indwell times,up to393 days after implantation.With regard to filter tilt,eight of the40filters(20%) were tilted at implantation;five of these eight filters(62%)had self-cen-tered by the time of retrieval(Table2). This is an important feature of the Celect filter because filter tilt and mi-gration often contribute to clinical complications and retrieval difficulties (25).Importantly,filter tilt did not af-fect the ability of the physician to safely remove the filter from the vena cava in the present study.With regard to neointimal growth,histopathologic analysis of the vena cava segments demonstrated that although the an-chor points were embedded in the ves-sel wall,the secondary legs were not incorporated in the wall.The fact that the anchor points embedded them-selves in the vessel wall is not surpris-ing.The anchor is expected to pene-trate the wall slightly,as this is the mechanism by which the filter resists

migration.Importantly,the neointimal

growth observed near the anchor

points did not inhibit retrieval in any

case;each filter was retrieved with an

acceptable level of force(Table3).Fur-

thermore,there was no evidence of

vena cava injury or inflammation at

any time point(Table4).

This study assessed the safety,per-

formance,and long-term retrievability

of the Celect filter.Results of this

study demonstrate that,in an ovine

model,the Celect filter can be safely

retrieved up to1year after implanta-

tion.All filter retrieval attempts up to

393days after implantation were suc-

cessful,suggesting that the design

changes did contribute to safe retriev-

als,and all were performed with clin-

ically acceptable levels of force and

without vessel injury(Tables3,4).

This study provides preliminary con-

firmation that the Celect filter is a safe,

reliable treatment option for tempo-

rary,long-term IVC filter placement.

Furthermore,study data indicate that

patients who previously would have

been required to permanently retain a

filter may have safe and successful fil-

ter retrieval at least1year after im-

plantation with the Celect vena cava

filter.

Acknowledgments:We thank the Wel-

don School of Biomedical Engineering at

Purdue University for animal husbandry

and surgical facilities and William D.

Voorhees III,PhD,Elizabeth Basquin

Krause,MD,and Lorraine Van Meter of

MED Institute,Inc,for assistance in man-

ual preparation.

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chard L,Therasse E,Soulez G.Recov-

ery G2inferior vena cava filter:technical

success and safety of retrieval.J Vasc

Interv Radiol2008;19:884–889.

16.Kaufman JA,Binkert CA,Drooz AT,

et al.Multicenter retrievability trial of

the Recovery G2filter.Presented at the

SIR Annual Scientific Meeting,Wash-

ington,DC,March15–20,2008.

17.Ashley DW,Mix JW,Christie B,et al.

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vena cava filter is not feasible after ex-

tended time periods because of filter

protrusion through the vena cava.

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18.Stavropoulos SW,Dixon RG,Burke CT,

et al.Embedded inferior vena cava filter

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382?Deployment and Retrievability of the Celect Filter March2009JVIR

19.De Gregorio MA,Gamboa P,Gimeno

MJ,et al.The Gu¨nther Tulip retriev-able filter:prolonged temporary filtra-tion by repositioning within the infe-rior vena cava.J Vasc Interv Radiol 2003;10:1259–1265.

20.Tay K-H,Martin ML,Fry PD,et al.

Repeated Gu¨nther Tulip inferior vena cava filter repositioning to prolong im-plantation time.J Vasc Interv Radiol 2002;13:509–512.

21.Rosenthal D,Swischuk JL,Cohen SA,

Wellons ED.OptEase retrievable infe-rior vena cava filter:initial multi-center experience.Vascular2005;13: 286–289.22.Neuerburg J,Gu¨nther RW,Rassmus-

sen E,et al.New retrievable percu-

taneous vena cava filter:experimen-

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224–229.

23.de Gregorio MA,Gimeno MJ,Tobio R,

et al.Animal experience in the Gu¨nther

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24.Wicky S,Doenz F,Meuwly JY,Portier

F,Schnyder P,Denys A.Clinical ex-

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25.Hoppe H,Nutting CW,Smouse HR,et

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Volume20Number3

列车时刻表计算

第一题 某同学买了一张列车时刻表.他注意到在北京和上海间往返的D31和D32次动车的运行时刻表如下: 他了解了D31次列车由北京开往上海,D32次列车由上海开往北京.这两次列车每天各发一趟.自北京到上海铁路长1463km.根据列车时刻表回答下列问题: (1)你从列车时刻表所列各项内容可以获得哪些信息(写出两条) (2)计算说明D31、D32次列车运行时间差为多少? (3)计算D39次列车由北京开往上海的平均速度是多少km/h? 第二题 在火车站,通常可见到列车运行时刻表,其中T114次列车时刻表可知,列车从上海至蚌埠 第三题 下表是T721次空调特快列车的运行时刻表。求:列车全程的运行时间和全程的平均速度分别是多少?在哪两个城市间行驶最快?当天16:00列车的瞬时速度多大? 第四题 根据如表所示的列车时刻表,计算该次列车从北京南站到上海虹桥站运行的平均速度,以及从曲阜东站到常州北站运行的平均速度. 某次列车的时刻表

火车由南京驶往上海,(1)实际运动的时间是多少?全程的平均速度是多少?(2)火车运行所花时间最多的路段是哪一段?此路段火车的平行速度最小吗?(3)火车运行路程最长的路程是哪一段?此路段火车的平行速度最大吗? 第六题 第七题 下表是某次列车的运行时刻表,列车准点运行时,由曲靖到安顺这段路程的平均速度为

第八题 根据右边列车时刻表计算出火车-直达特快Z51从北京到南通所需要的时间,如果从北京到南通火车行驶的距离是1325km,请计算出这列火车行驶的平均速度是多少km/h(结果保留整数) 第九题 根据图中的列车时刻表,计算D5次列车从葫芦岛北到沈阳的平均速度.(时间和路程的单位分别用h和km) 第十题 下表是从北京到杭州和从杭州到北京的T31、T32列车时刻表,请你根据表中信息求解下列问题:

陕西高考数学文科试卷及答案

文科数学(必修+选修Ⅱ) 一、选择题:在每小题给出的四个选项中,只有一项是符合题目要求的(本大题共10小题,每小题5分,共50分). 1.集合A={x -1≤x≤2},B ={x x <1},则A∩B= [D] (A){x x <1} (B ){x -1≤x≤2} (C) {x -1≤x≤1} (D) {x -1≤x<1} 2.复数z= 1i i 在复平面上对应的点位于 [A] (A)第一象限 (B )第二象限 (C )第三象限 (D )第四象限 3.函数f (x)=2sinxcosx 是 [C] (A)最小正周期为2π的奇函数 (B )最小正周期为2π的偶函数 (C)最小正周期为π的奇函数 (D )最小正周期为π的偶函数 4.如图,样本A 和B 分别取自两个不同的总体,它们的样本平均数分别为A B x x 和,样本标准差分别为s A 和s B ,则 [B] (A) A x >B x ,s A >s B (B) A x <B x ,s A >s B (C) A x >B x ,s A <s B (D) A x <B x ,s A <s B 5.右图是求x 1,x 2,…,x 10的乘积S 的程序框图,图中空白框中应填入的内容为 [D] (A)S=S*(n+1)

(B )S=S*x n+1 (C)S=S*n (D)S=S*x n 6.“a >0”是“a >0”的 [A] (A)充分不必要条件 (B )必要不充分条件 (C )充要条件 (B )既不充分也不必要条件 7.下列四类函数中,个有性质“对任意的x>0,y>0,函数f(x)满足f (x +y )=f (x ) f (y )”的是 [C] (A )幂函数 (B )对数函数 (C )指数函数 (D )余弦函数 8.若某空间几何体的三视图如图所示,则该几何体的体积是 [B] (A )2 (B )1 (C )23 (D )13 9.已知抛物线y 2 =2px (p>0)的准线与圆(x -3)2+y 2=16相切,则p 的值为 [C] (A )1 2 (B )1 (C )2 (D )4 10.某学校要招开学生代表大会,规定各班每10人推选一名代表,当各班人数除以10的余数大于..6.时再增选一名代表.那么,各班可推选代表人数y 与该班人数x 之间的函数关系用取整函数y =[x]([x]表示不大于x 的最大整数)可以表示为 [B] (A )y =[10x ] (B )y =[310x +] (C )y =[4 10 x +] (D )y = [510 x +] 二、填空题:把答案填在答题卡相应题号后的横线上(本大题共5小题,每小题5分,共25分). 11.观察下列等式:13+23=(1+2)2,13+23+33=(1+2+3)2,13+23+33+43= (1+2+3+4)2,…,根据上述规律,第四个等式.....为13+23+33+43+53 =(1+2+3+4+5)2(或152). 12.已知向量a =(2,-1),b =(-1,m ),c =(-1,2)若(a +b )∥c ,则 m = -1 .

下元八运二十四山九宫飞星图1

下元八运二十四山九宫飞星图1 收藏人:爱周中学20140203 | 阅:1 转:500 | 分享 微信朋友圈 腾讯空间 新浪微博 腾讯微博 人人网 开心网 搜狐微博 推荐给朋友 举报 | 来源 下元八运二十四山九宫飞星图 八运壬山丙向 八运子山午 向八运癸山丁向

八运丑山未向 八运艮山坤 向八运寅山申向 八运甲山庚向八运卯山酉向八运乙山辛向

八运辰山戌向八运巽山乾向八运已山亥向 八运丙山壬向八运午山子向八运丁山癸向 八运未山丑向八运坤山艮向八运申山寅向

八运庚山甲向八运酉山卯向八运辛山乙向 八运戌山辰山八运乾山巽向八运亥山已向

旺山旺向( 旺財旺丁) 坐未向丑, 坐丑向未, 坐亥向巳, 坐巳向亥, 坐巽向乾, 坐乾向巽。 上山下水( 捐財傷丁) 坐戌向辰, 坐辰向戌, 坐申向寅, 坐寅向申, 坐坤向艮, 坐艮向坤。 雙星到山( 旺丁不旺財) 坐壬向丙, 坐甲向庚, 坐丁向癸, 坐酉向卯, 坐午向子, 坐辛向乙。 雙星到向( 旺財不旺丁) 坐丙向壬,坐庚向甲,坐癸向丁,坐乙向辛,坐卯向酉,坐子向午。 玄空飞星断略 盘局确定之后,就要对盘局得凶吉,作出合乎易理得判断。这种判断包括三方面得关系与内容。其一、时运判断与五行判断得关系。其二、环境判断与盘理判断得关系;其三、山向两飞星得关系。 玄空之法,着重于时运得判断,而把五行生克得判断放在次要得地位。时运得判断,分得时与失时两个方面。若某星当运。其生我为吉,克我亦吉,被旺星所生,自然吉利,但被

旺星所克,证明属我之气为衰气,旺气克衰气,当然就是吉。比如七运立卯山酉向,向方两飞星为三七,三为山星,七为向星,两者得关系就是七赤金克三碧木。七为旺气,三为衰死之气,旺气克衰气,自然为吉。相反,生我之星为衰星,我必当凶;克我之星为衰星,我必更凶,所以,宅命得凶吉旺衰,就是以入中之星到山到向得情况为转移。若得旺山旺向。全宅皆旺;若得上山下水,全宅皆衰。以得时、失时为圭臬得判断方法,就是玄空风水学得一大特色,而五行生克得判断,就是在得时、失时得前提下运用得。 玄空之法,就是把山水环境与盘理相结合进行判断得。山水环境实在,就是判断得基础;而盘理得判断,则就是根据易理得逻辑证明。山水环境优美,盘理证明就是旺山旺向,则就是建房立葬之理想地方。山水环境残缺,即使盘理证明就是旺山旺向,也不就是好地方。山水环境优美,盘理证明就是上山下水,或反吟伏吟,或出卦骑线,或遇时年凶煞等,就要依山水环境调整卦象,或正向、或兼向、或取城门、或坐满朝空、或坐空朝满、或特时而用,甚至弃而不用。所谓收山脱煞,所城门二宫,全以环境得状态而决定取舍。在行为上,可以依环境而定盘卦,就地取材,就近取址,然后据盘理而调整。现代城市。寸地千金,不由得您任意挑选,只好将就使用,按盘理进行合理调整。亦可以依盘理而找寻合乎要求得环境,踏破千山万水,去觅理想之地。这在地大人稀得地方就是可以办到

(完整word)路程速度时间应用题(三年级)

路程速度时间应用题 解决路程、速度、时间这类问题,我们必须要理清这三者之间的数量关系: 路程=速度×时间;时间=路程÷速度;速度=路程÷时间。 例1. 一辆大巴车从张村出发,如果每小时行驶60千米,4小时就可以到达李庄。结果只用了3个小时就到达了。这辆汽车实际平均每小时行驶多少千 米? 试一试: 一列火车,提速前平均每小时行驶71千米,从秦皇岛到邯郸用12小时,提速后平均每小时行驶95千米,提速后从秦皇岛开往邯郸大约需要几小时? 例2. 石家庄到承德的公路长是546千米。红红一家从石家庄开车到承德游览避暑山庄,如果平均每小时行驶78千米,上午8时出发,那么几时可以到 达? 试一试: 一辆从北京到青岛的长途客车,中途经过天津和济南。北京到天津137km;天津到济南360km;济南到青岛393km。早晨6:30从北京发车,平均每小时行驶85千米,大约何时可以到达青岛?

例3.从小明家到济南共360千米,爸爸开车上午10时从家出发,平均每小时行驶110千米,他下午1时能到达济南吗? 试一试: 小楠家到学校的路程长302米,他下午1时56分从家出发,2时1分到达学校。小楠平均每分钟大约走多少米? 课外作业 1.从甲地到乙地936千米,一辆车3小时走216千米,照这样的速度, 从甲地出发经过几小时后可以到达乙地? 2.汽车以72千米/时的速度从甲地到乙地,到达后立即以48千米/时的 速度返回甲地,求该车的平均速度 3. 一辆大巴车从深圳出发开往广西,原计划每小时行驶60千米,8小时 就可以到达目的地。结果只用了6个小时就到达了。这辆汽车实际平 均每小时行驶多少千米?

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