estenosis (1-I 1) an other adverse outcomes (12, ;3) after coronary artery interventions to predict from clinical or angiographic data. coronary ultrasound imaging provides uni ditionai information on coronary ~?ery status after an ~~terve~tio~~ (14-17), it might be useful in predicting patient outcome. A prior study (18) has evaluated the utility of~~t~coro~ary ultrasound imaging in predicting outcomes; catheterization was not p its ability to fully document adverse outcomes. The purpose of this study was to determine the association between qualitative and quantitative data assessed by intracoronary ultrascund imaging after coronary artery interventions and &verse outcome in a ~op~~at~onof patients

From the Department of Medicine, Division of Cardiology, Duke Umversity Medical Center, Durham, North Carolina. This work was presented in part at the 41st Annual Scientific Session, American College of Cardiology, Dallas, Texas, April 1992. Manuscript received February 27,1’392; revised mamlscript received May 23, 1992, accepted May 29, 1992. Address for correstiondence Charles J. Davidson, MD, Box 31195, Duke University Medical Center, Durham, North Carolina 27710. 01992 by the American

College of Cardiology

with careful follow-up study cat~ete~,izatio~.

in&

img

a high rate of repeat

S 0 The study group comprise tad successful coronary residual diameter stenosis of ~5 rwent balloon angioplastyonly, tomy (directional coronary at~ere~tomy in 13and t~a~s~~rninal extraction atherectomy in 3) and li had treatment. Of the patients undergoing athere

search. g. Int:acoronary ultrasound imagingwas performed with a 20- Hz, 4.W mechanically rotated system (Boston Scientific). immediately after 0735-109719265.00

1386

TENAGLIAETAL. CORONARYULTRASOUNDANDlNTERVENTlONALOClTCOMES

Figure I, Intracoronary ultrasound image of the left anterior descending artery after laser angioplasty. An area OFminor dissection is notedby the arrow. The patientwas subsequently noted to have restenosis.

successful interventions, the imagingcatheter was advanced over the coronary guide wire to a position distal to the lesion, and images were obtained as the catheter was slowly withdrawn. Images were recorded on videotape for later off-line analysis. Previous work from our laboratory (19) has demonstrated axial and lateral resolution of 0.39 and 1.30mm, respectively, for ultrasound imaging. ~~tr~~~~ imageanalysis. Qualitative analysis was pcrformed by consensus of three observers using previously suggested criteria (20)and included determination of plaque composition as hard or soft, plaque topography as eccenwic or concentric and presence or absence of dissection. plaque was defined as vessel wall thickening with bright reflected echoes or distal acoustic shadowing, or both, consistent with the presence of calcium. Soft plaque lacked these characteristics and was represented as less dense echoes of thickened vessel wal). Eccentric plaque was defined as involving 950% of the total circumference of the as defined as separation of from uivocal dissections were c d by tmst medium through the guide catheter during ultrasound imaging. In addition, dissection was graded as minor if the dissection flap extended around ~33% of the circumference of the artery (Fig. 1) or major if the dissection extended around ~33% of the circumference unntitative measurements were performed on a ~~ewlett-PackardSONOS-I system. Analvsis included moasurement of minimal lumen diameter and p!animetry of lumen area and the area enclosed within the media (Fig. 3). The media was defined as the first echolucent region just outside the echogenic plaque and intima. Plaque area W~L calculated as area within the media minus lumen area. Percent area stenosis was calculated as plaque area divided

JACC Vol. 20. No. 6 November 15. !992:1385-90

re 2. lntracoronary ultrasound image demo~str~~ti~~ major dissection (arrow)extending>33!75 of the circu~~~~r~~c~ of the artery.

by area within tbe media. All measure both the treatment site and at the a adjacent reference seg as could not be patients quantitative measu d because of technically i btained before calibration o ware. The variability of qualitative analysis was determined by aracteristics of 20 lesions vcrs at tl- J separate ti values of these obse plaque, 0.42 for eccentric versus concentric plaque and 0.46 for dissecti dissection. These values indicate good reprodu qualitative data (21). Variability of quantitative measurements from our laboratory has been previously reported (14). Correlation coefficients for inter- and intraobserver measurements of bot lumen area and area within the media ranged from 0.91 to 0.98. ic a pat pr lowed for up to 1 year or until an adverse event occurred. An adverse event was defined as cardiac death, bypass surgery of the dilated artery, myocardial infarction or restenosis. All patients were requested to return, even if asymptomatic, for follow-upangiography, which was performed at 6 months or earlier in the presence of recurrent symptoms. Cineangiograms, in the view demonstrating the most severe stenosis, were digitized and quantitated with a semiautomated edge detection system, the Duke University Quantitative/ Qualitative Evaluation System (22). Restenosis was defined as >50% diameter stenosis at follow-up catheterization. Statistics.Categoricdata are presented as proportions with 95% confidence limits and continuous data as mean -tSD. Intracoronary ultrasound results after the intervention

November 15, 1992:1385-90

of patients and ecce

were detecte g in 42% of patients, on after the

in

SSfLFI treatmemt of the ~atbeter~za~~o~ Isbora-

after the i~terve~t~o~~ for abrupt closure 8r early recurrent symptoms; one had a myocardial infarctiola. Two patients were lost to follow-up study. Of e ~ernai~i~g62 patients

without an adverse clinical event fore repeat catheterization, 56 (90%)agreed to undergo P procedure. Of these, 25 (45%)had restenosis. Thus, a total of 30 patients (45%)had an adverse outcome after intervention and 37 (55%)had no subsequent adverse outcome (Fig. 4). redictors. Table 1 shows the proportion of Figure 4. Patient outcomes. Cath = cardiac catheterization; PTCA = percutaneous transluminalcoronary angioplasly; recatheterization. PTGA 42, ____4 7 1 year -----s. =-.--+

2 tncomplete clinical

Atherectomy

16. Laser

6 No Cath.

e association of dissection outcome occurred in 40% (95%confidence

64% (CI 35% to 92%) of patients with exe ment (p = NS). Bverall, dissection was note 70%) of patients with angioplasty, 19%KI 8% to 38%)of patients with atherectomy and 64% (C1 35% to 92%) of patients with laser treatment. A trend toward an increased

follow-up

1 Cardiac death 3 Bypass surgery 1 Myocardial infarction

‘,

2 Eligible for recatheterization

~56

11

follow-up

was statistiea~~y significant

(90%)

Recath

No Adverse

/’ 25

Restenosis

31

No Restenosis

Adverse ‘i Outcome / (n-30)

NoAdverse

/

P

Outcome

RI

No Adverse W F13cYe

Adverse Outcome (n = 30)

Outcome

Hard plaque

69 (52 to 86)

64 (48 IO 80)

Eccenlric plaque

50 (32 to 69)

35 (20 to 51)

0.31

Dissection

63 (46 to 81)

35 (20 to 50)

CO.05

(II = 37)

Data are presented as percent (95% confidence intervals).

PI_

p Value 0.79

1388

TENAGLIA ET AL. CORONARY ULTRASOUND

AND INTERVENTIONAL

JACC Vol. 20, No. 6 November IS, 19921385-9-96)

OUTCOMES Table 2. Dissecria?n by Intracorcmary Versus Angiography

Ukasounc! -I Dissection Gj; Angiography

--

.---

___.__

AiFu5i:i,i

T;ts& .

_-.

I~kwrion by ulbawund I%cnt Absent

*? IJ

i9

j

?@

_-_I

No Adverse Outcome

Adverse Outcome

Minor

Major

CII

p < 0.05.

None

Figure 5. Percent of lesions with major, minor or no dissection noted after an intervention in patients with and without a subsequent :\dv:rse 0utcomC. for patients with il su~se~t~e~r adverse outcome was noted for balloon angioplasty and athercctomy but not for laser treatment (Fig. 6). There was a significant difference between dissections noted by intracoronary ult~aso~l~d i aging and those noted by angioljraphy (p i 0.05). Intracoronary ultrasound imaging detected dissection in 19 lesions (28%) in which angiogra~hy did not show a dissection (Table 2). There was no significant difference in angiographically detected dissections in those with (27% [Cl 11% to 43%]) and without (37% [CI 19% to a subsequent adverse event. an~~tat~v~predictors. Table 3 shows the lumen diameter, lumen area, plaque area and the percent area stenosis immediately after intervention in the patients with and without a subsequent adverse event. The results were similar for the two groups. Thus, quantitative characteristics measured by intracoronary ultrasound imaging and used to determine residual stenosis after the intervention demonstrated no diff$rence between those with or without a later adverse outcome. Table 3 also shows the extent of disease found by intracoronary ultrasound imaging in the adjacent angio~r~~hical~y normal reference segment. The severity of dis-

ease

within the reference seg eat was not associated with

rate of dissection

Figure 6. Percent of lesions with dissection, according to initial treatment group, in patients with and without a subsequent adverse outcome. ,**

9loon Angioplasty

r _I__-

p = 0.05

-

Atherectomy

-l-l_~.~--_--

Laser

The current study is the first study with ca phic recat~~teri~atio~ in ta obtai~ablg by intracoro imaging after an iuterve~tio~a~ procedure c quent early and late adverse events. In 49 patients studied, the only ~itrasound variable associated with subse adverse events was the presence observed almos: twice as often event. In addition, a greater exten of adverse oiiicome. be associated with a greater toward an association

size and needs to be verified in a larger ~o~~~~t~on. Qualitative data other than dissection, such as plaque eccentricity or the presence of hard plaque, were not associated with patient outcome. In addition, quantitative data, such as residual stenosis or extent of reference segment disease, were also not predictive. The only prior published study (18) examining ultrasound predictors of adverse outcome found different results. In that study of 66 lesions, restenosis was significantly more common in patients with concentric plaque without fracture or dissection than in those with dissection or with eccentric plaque without dissection. However, that study was not designed specifically to examir.: restenosis and adverse

p 8 0.06

Table 3. Quantitative Results No Adverse

Lumen diameter (mm) Lumen area (m&j Plaque area (mm’) Percenl area stenosis Treated site Reference site Adveree No Adveree OUtcome Outcome

Adverne No Adverse Ouloome Oulcome

Adverse NO Adveree Outcome Outcome

Adverse Outcome (II = 29)

Outcome (II = 30)

p Value

2.6 + 0.5 6.9 _+ 2.7 8.5 t 4.0

2.1 t 0.6 7.5 r 3.2 10.6 f 5.1

0.65 0.49 0.29

54 5 19 25 -+ 21

57 -+ 14 27 -c 21

0.79 0.G

Data are presented as mean f SD.

stenosis rates (6,9). However, studies f%wd dissection ~~re~ate ecent work from our i~st~t~tio~

ated with an increased r

angiographic studies have also demonstrate

I. Bourasha MG. Lesperance J. Eastwood C, et al. Clinical, physiologic, anatomic and procedural faciors predictive of restenosrs after percutaneous transluminal coronary angiopiasty. J Am Coil Cardiol 1991;1fl:368lb. 2. flirshfeld JW Jr. Schwartz JS. Jug0 R. et al. Rebtenosis afler caranary angioplasty: a multivariate statistical model to relate lesion and prc.,edure variables to restenosis. J Am Coil Cardiol lY91;18:647-56. 3. Leimgruber PP. Raubin GS. Hollman J, et al. Restenosis after successful coronary angioplasty in patients with single-vessel disease. Circulation 1986:73:710-7. 4.

May reported angiographic predictors of restenosis -8,10). In contrast, our study revealed no relation between several intracoronary ultrasound measllrements of al lumen diameter, lumen area, res stenosis) and subsequent adverse pla outcome. The discrepancy between our results with ang~ographicanalysis may r limitations of contrast angiography 1 eccerltric or irregular lumen dimensions after a procedure, a limitation that may be overcome by the use of intracoronary ultrasound imaging (19,241. No prior angiographic study has examined the extent of atherosclerotic disease in the adjacent artery as a predictor of adverse outcome. In the present study, refere disease, as determined by intracoronary ultrasound, was not associated with adverse events. llications. Further studies will be needed to determine whether modificationofcoronary artery interventional procedures on the basis of the ultrasound appearance will improve patient outcome. For example, on the basis of the present results, dissections could potentially be treated with atherectomy of the flap or alternatively by stent place-

oubin GS. Kmg SB Ill. Douglas JS Jr. Cox WR. Importance of stenosis morohology in the estimation of resteoc& risk after elective percutaneous tidnsluminn! coronary angioplasly. Am J Cardiol IY89:63: 33-4.

5, Fleck E. Rcght V, Lehnert A, Dacian S. Dirshinger J, Rudolf W. Restenosis after balloon dilatation of coronary stenosis multivariate analysis of potential risk factors. Eur Heart J 1988;9:15G8C. 6. Guiteras Val P. Bourassa MC. David PR, et al. Restenos ful percutaneous transluminal coronary angioplasty: the Institute experience. Am J Cardid 1987;5O:IB-SB. 1 Lambert M. Bonan R, C&e G, et al. Multiple coronary angioplasty: a model to discriminate systemic and procedural factors related to restenosis. J Am Coil Cardiol 1988;12:3rO-4. 8 Mata LA. Bosch X. David PR, Rapold NJ, Corcos T. Bourassa MC. C”inical and angiographic assessment 6 months aller double vessel p_ cutaneous coronary angioplasty. J Am Coil Cardiol 1985;6:1239-44. 9. Matthews BJ, Ewels CJ. Kent KM. Coronary dissection: a predictor of restenosis? Am Heart J 1988:115:547-54. IO.Rapold HJ, David PR. Guiteras Val P, Mata AL, Crean PA, Bourassa MG. Restenosis and its determinants in first and repeat coronary angioplasty. Em Heart J IY87;8:575-86. II. Leimgruber PP. Roubin GS. Anderson I-IV. et al. lntluence of intimal dissection on restenosis after successful coronary angioplasty. Circulation 1985:72:530-5. 12. Goldbaum T, DiSciascio 6. Cowley MJ, Velrovec GW. Early OCCiUSiOn following successful coronary angioplasty: clinical and angiographic observations. tithe1 Cardiovasc Diagn 1989;17:22-7. 13. Ellis SG, Roubin GS, King SB Ill, et al. Angiographic and clinical nrediclors of acute closure after native vessel coronary angioplasly. r--------Circulation 1988;77:372-9. 14. Tenaglia AN, Buller CE. Kisslo KB. Stacks RS. Davidson CJ. Mechanisms of balloon angioplasty and directional coronary atherectomy

1390

15.

16.

17. IS.

19.

TENAGLIA CORONARY

ET AL. ULTRASOUND

AND

lNTERVENTlONAL

OUTCOMES

as assessed by intracoronary ultrasound. J Am Coli Cardiol 1992;20:68591. Tobij JM, Mallery JA, Gessert J, et al. Intravascular u!trasound crosssectional imaging before and after balloon angioplasty in vitro. Circulatiurl 19d9:6O:S73-8i. Pandian XC, Kreis A, Brockwav B, Sachaioe‘ A, Caro R. ln!ravascuiar high freuucncy two-dimensional ultrasound detection of arterial dissection andintimal flap. A;n J Cardiol 19W;f,S:12711-80. Davidson CJ, Sheikh KH, Kisslo KB. et al. Intracoronary ultrasound evaluation of interventional technologies. Am 3 Cardiol 1991;68:1305-9. Honye J, Mahon DJ, Jain A, et al. Morphological effects of coronary balloon angioplasty in vivo assessed by intravascular ultrasound imaging. Circulation 1992;85:1012-25. Davidson CJ. Sheikh KH, Harrison JK. et al. !ntravaszular ultrasonography versus digital subtraction angiography: a human in tiivo comparison of vessel size and morphology. J Am Coil Cardiol l990;16:633-6.

JACC Vol. 20. No. 6 November 15. P992:1285-90

20. Gussenhoven EJ, Essed CE, LancCe CT, et al. Arterial wall characteris. tics determined by intravascular ultrasound imaging: an ill vitro s!udy. J Am Coil Cardiol 1989;14:947-52. 21. Lac&s JR, Koch GG. The measurement of observer agreement for categorical delta. Biometrics 1977;33: I W-74. 22. Fortin DF, Spero LA, Cusma JT, Califf RM, Stack RS. GLike bniversity (Iwanlltutive:pualrtatlvr Evalualir~ Sysi~m CDUQUES). A muliiuser, nerworked qualitative and rloantiiatiie mgiographic sys:em for high volume clinical studies. Fourtnl iatrreatior& Symposium on Coronary Arteriography. 1991:172. 23. Fortin DF, Frid DJ. Nelson CL, et nl Restenosis rates after dissect& during angioplas!p: ? case of withdrawal bias (abstr)? J Am CotI Cardiol 1992;19(suppl &168A. 24. Nissen SE. Grines CL, Gurley JC. et al. Application of a new phasedarray ultrasound imaging catheter in the assessment of vascular dimensions: in vivo Comparison to cit~ea~~~o~~~~~~~y.Circulation 1990;81:660-b.

Intracoronary ultrasound predictors of adverse outcomes after coronary artery interventions.

The purpose of this study was to determine the association between qualitative and quantitative lesion characteristics as assessed by intracoronary ul...
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