JVS M Della Corte Mar 2000

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JOU R NAL O F VAS CU L AR SU R G E R Y496 S i n gh -R a n g e r e t a l M ar ch 2000

endo leak age o r slipp age o r m ig r at ion o f t he st en tg r af t . We ob se r ved lumbar and / o r mesen t er ic ar te r y

f illing in seven p at ien t s, bu t th is was absen t af te r 6mon ths.

W ith in the who le g r ou p , 5 d ays af ter endo lum inalexclusion, ther e was a signif icant incr ease (P = .02 ) intotal aneu r ysm volume (25 o f the o r iginal 30 p at ien ts,10 P TF E endo g r af ts and 15 T alen t endo g r af t s). Th emedian incr ease var ied f r om 6.03 mL ( r ange, 13.16 -+29.31 mL ) f o r the P TF E g r ou p to 17.35 mL ( r ange, 404.31 -+87.06 mL ) f o r the Talent g r ou p . Th e actu-al volumes ar e sho wn in F ig 5.

F o r t h e P T F E g r ou p , t h e r e wa s a m ed ianincr ease o f 0.275 m L ( r ange, 13.95 -29.35 m L ) inAAA vo lum e at 6 m on t h s. Th is d id no t r each sig-n if icance (P = .92 ) . N ine p at ien t s r eached a 1 -year f o llow-u p w it h a m ed ian inc r ease in t o t al sac vo l-

um e o f 0.98 mL

(r

ange,

3.67 -17.69 mL

) , wh ichagain wa s no t sign if ican t (P = .13 ) . A f u r t he r 7p at ien t s at t he 18 -m on t h f o llow-up had a gain inm ed ian vo lum e o f 1.68 m L ( r ange, 0.77 -30.25m L ) w it h no st a t ist ica l sign if ica nce . O n ly t h ep at ien t w it h a P T F E g r af t b lock ed b y sadd le em bo -lu s and con t iguou s t h r om bo sis sho wed sac sh r ink -age, f r om a p r eo p e r at ive vo lum e o f 109.31 m L t o53.17 m L at 1 year .

In the Talen t g r ou p , ther e was a con t inu ing signif -icant decr ease (P = .012 ) in the total aneu r ysm volume(med ian, 19.20 mL ; r ange, 155.67 -+8.26 mL ) over the next 6 mon ths of f ollow-up . At 1 year , ther e wer e

f ou r p at ien t s, all o f who m sho wed a decr ease inaneu r ysm vo lume app r oach ing t hat o f the I AVC(med ian, 12.96 mL ; r ange, 35.55 to 3.91 mL ).

An analysis o f an t e r o p o st e r io r and t r an sve r sed iam et e r s sho wed no sign if ican t change f o r eithe r g r ou p ove r the in it ial incr ease in the t o tal aneu r ysmvo lum e and f o r t he P T F E g r ou p t h r ou ghou t t hewho le st ud y p e r iod. F o r t he Talen t g r ou p , bo t hd iam et e r s sho wed sign if ican t (P < .01 ) dec r easesf r om 6 mon ths on wa r ds. The an te r op oste r io r d iam-

T ab le III . A comp ar ison o f the t r ue and measu r ed d iamete r s of g lass p han tom s with the use of SCT A andp ost p r ocessing sof twa r e*

T r u e d i a m e t e r s ( mm ) M e a s u r e d d i a m e t e r s ( mm )

A n e u r y s m A n t e r o p o s t e r i o r T r a n s v e r s e A n t e r o p o s t e r i o r T r a n s v e r s e

A 43.33 0.1 48.83 0.07 44.50 0.46 49.18 0.64B 55.44 0.06 54.81 0.05 56.75 0.05 55.34 0.46C 60.51 0.07 60.47 0.1 61.19 0.71 60.69 0.63D 69.81 0.07 69.84 0.06 70.08 0.50 70.08 0.50E 76.54 0.05 78.92 0.03 75.83 0.47 79.41 0.48F 79.74 0.03 79.80 0.03 80.70 0 80.01 0.66

*E ach f igu r e is the m ean o f 8 measu r em en t s and the SD .

T ab le I V. R esu lt s ob tained f r om the com p ar ison b etween SCT A and sizing ang ioca thete r *

S p e a r m a n s N ec k l e n g t h N ec k d i a m e t e r D i s ta l c u ff l e n g t h D i s ta l c u ff d i a m e t e r L e n g t h o f v a s c u l a r c o rr e l at i o n r e s u l t s ( mm ) ( mm ) ( mm ) ( mm ) c h a nn e l ( mm )

0.99 0.85 0.99 0.99 0.96P value .02 .04 .02 .03 .02Con f idence in ter vals 2.93 -4.07 mm 0.93 -2.07 mm 2.17 -0.41 mm 0.26 -1.16 mm 7.93 -5.65 mm

*Th e con f idence in ter vals r ef er to the lim it s of ag r eemen t bet ween the SCT A and ang iocatheter m easu r em en t s.

T ab le V . Th e in t r aob se r ve r and in te r ob se r ve r coef -f icien t of r ep eatab ility in the measu r emen t o f aneu r ysm vo lumes*

I n t r a o b s e r v e r I n t e r o b s e r v e r c o e ff i c i e n t o f c o e ff i c i e n t o f

P a r a m e t e r m e a s u r e d r e p r o d u c i b i l i t y r e p r o d u c i b i l i t y

To tal AAA volume 5.7 m L 4.39 m LIAVC volume 4.38 m L 6.49 m LMaximum anter op oster io r 3.40 mm 4.42 mm

diame ter Maximum t r ansver se diameter 2.31 mm 2.46 mm

*The r ange of to tal AAA volume was 99.75 to 402.66 m L ; theI AVC volumes wer e 44.10 to 319.63 ; the maximum diameter s wer e33.9 to 82.4 mm (anter op oster io r ) and 39.2 to 85.9 (t r ansver se).


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JOU R NAL O F VAS CU L AR SU R G E R YVo lume 31, N umber 3 S i n gh -R a n g e r e t a l 497

ete r decr eased b y 7.35 mm ( r ange, 18.7 to +1.3mm ) at 6 mon ths and b y a f u r the r 5.0 mm f r om the6-m on th measu r emen t s ( r ange, 7.8 to +3.6 mm ) at1-year f o llow-up . I n sim ilar f ash ion, the t r ansve r sed iamete r s we r e alt e r ed 5.4 mm ( r ange, 20.3 t o+2.2 mm ) at 6 m on t h s and a f u r t he r 2.45 mm

( r ange, 8.1 to 2.3 mm ) at 1 year .F o r bo t h g r ou p s, imm ed iat ely af t e r t r eat men t ,

the r e was a sign if ican t decr ease (P < .005 ) in the vo l-ume of the I AVC, wh ich then r emained st ab le f o r the du r at ion o f f o llow-up . Th e decr ease in vascu lar chann el vo lume was demon st r ated f o r 22 o f the 30p at ien t s. I n t he P T F E g r ou p , t he in it ial m ed iandecr ease wa s 38.51 m L ( r ange, 235.04 to +25.51m L ); in the Talen t g r ou p , the in it ial med ian d ecr easewa s 8.52 m L ( r ange, 155.76 to +4.92 m L ). The

in it ial inc r ease in t o t al aneu r ysm vo lum e wa sdemon st r ated to b e the r esu lt o f the f o r mat ion o f new p e r ig r af t th r ombu s when a p o r t ion o f the I AVCvo lume was exclud ed b y the dep loymen t of the p r os-theses. Th is est imate wa s ob t ained b y a ca lcu lat iono f t he d iff e r ence bet wee n t he m easu r ed t o t al

aneu r ysm vo lume and the vo lume of the I AVC. I nthe Talen t g r ou p , sac vo lume decr eased at 6 mon thsand 1 year , lead ing to g r oss sac sh r ink age; bu t th iswas no t ob se r ved in the P TF E g r ou p , in wh ich thevo lume r emained un changed. Th e t wo p at ien t s int he P T F E g r ou p w it h endo leak age con t inu ed t ohave an incr ease in their to tal aneu r ysm vo lume un t ilf u r t he r t r eat men t . O n ly on e of these p at ien t s hadany demon st r ab le incr ease in an te r op oste r io r / t r ans-ver se d iamete r .

F ig 5. Box wh isk er p lo ts sho w the changes in AAA and I AVC vo lume af ter endo lum inal exclu-sion with P TF E o r Talen t endo g r af ts. The med ian is the ce n t e r l i n e in each bo x. The u pp e r a n d l o w e r l i n e s ar e the 75 th and 25 th p er cen t iles, r esp ect ively. Th e b a r s r ef er to the m in imum andmaximum values of the r ange. A , Th e change in to tal aneu r ysm af ter g r af t ing wit h P TF E ; B ,the change in I AVC volum e af ter g r af t ing with P TF E ; C , the change in to tal aneu r ysm vo lumeaf te r g r af t ing wit h T alen t ; and D , the change in I AVC vo lum e af t er g r af t ing wit h T alen t .

BA

C D


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JOU R NAL O F VAS CU L AR SU R G E R Y500 S i n gh -R a n g e r e t a l M ar ch 2000

abdo m inal ao r t a du r ing m id-t e r m f o llow-u p . E u r J VascE ndo vasc Su r g 1997 ;14 :84 -90.

4. M ay J , Wh ite G , Yu W, Wa ugh R , Step hen M , H arr is J . Ap r o sp ect ive st ud y o f anat om ico-p at ho log ica l changes inabdo m inal ao r t ic aneu r ysm s f o llowing endo lum inal r ep air : ist he aneu r ysm al p r ocess r ever sed? E u r J Vasc E ndo vasc Su r g

1996 ;12 :11-7.5. M ay J . Th e ins and ou t s of the exclud ed abdo m inal ao r t ic

aneu r ysm : d ec r easing d iame t e r s and d ilat ing neck s. JE ndo vasc Su r g 1997 ;4 :31-2.

6. Ber nh ar d VM . E ndo g r af t managemen t of abdo m inal ao r t icaneu r ysm wit h gu idan t -E VT d evices: cu rr en t U S t r ials .Abst r act p r esen ted at the M almo I n ter nat ion al sym p osium ;Jan 29 -30 1999 ; M almo, Sweden.

7. Yusuf SW, Wenh am P W, H op k inson BR . Th e No tt inghamexp er ience. I n : H op k inson B, Yusuf W, Wh itak er S, Veit h F ,ed ito r s. E ndo vascu lar su r ger y f o r ao r t ic aneu r ysm s. L ondon :WB Saund er s; 1997. p . 221 -9.

8. B land JM , Alt m an D G . St at is t ica l m et hod s f o r assessingag r eem en t bet ween two m ethod s of clin ica l m easu r em en t .L ancet 1986 ;1 :307 -10.

9. Sham p o M A, Kyle R A. G od f r ey H oun sf ield : develop er o f com p u ted t om og r ap h ic scann ing . M ayo C lin P r oc1996 ;71 :990.

10. Ad isesh iah M , B r ay AJ , Be r ge r on P , R ap hael M J .E ndo lum inal r ep air of lar ge abdo m inal ao r t ic aneu r ysm s usingP TF E : a f easibility stud y. J E ndo vasc Su r g 1997 ;4 :286-9.

11. Wh it e R A, D on ayr e C , Ko p cho k G , Wa lo t I , W ilson E ,deVir g ilio C. I n t r avascu lar u lt r asound : the u lt imate too l f o r abdo m inal ao r t ic an eu r ysm assessm en t and endo vascu la r

g r af t deliver y. J E ndo vasc Su r g 1997 ;4 :45-55.12. van E ssen JA, Gussenho ven E J , van d er L ugt A, H u ijsm an

P C, van M u isw ink e l JM , van Sam b ee k M R H M , e t al.Acc u r at e assessm en t o f abdo m in al ao r t ic aneu r ysm wit hin t r avascu lar u lt r asound scann ing : validat ion with com p u tedtom og r ap h ic ang iog r ap hy. J Vasc Su r g 1999 ;29 :631 -8.

13. M angell P , M alin a M , Vog t K , L indh M , Sch r oede r T,R isber g B, et al. A r e self -exp and ing sten t s sup e r io r to b al-loon -exp and ed in d ilat ing ao r tas? An exp er ime n tal stud y inp igs. E u r J Vasc E ndo vasc Su r g 1996 ;12 :287-94.

14. Ba lm R , Kaatee R , Blank ensteijn JD , M ali WP , E ik elboo mBC. CT -ang iog r ap hy o f abdo m inal ao r t ic aneu r ysm s af t e r t r ansf em o r al endo vascu lar aneu r ysm m anagemen t . E u r J VascE ndo vasc Su r g 1996 ;12 :182-8.

Sub m itt ed F eb 11, 1999 ; accep ted Aug 6, 1999.

JVS M Della Corte Mar 2000

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