Laser-Assisted Coronary Angioplasty in Patients with Severely Depressed Left Ventricular Function:...

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Laser-Assisted Coronary Angioplasty in Patients with Severely Depressed Left Ventricular Function: Quantitative Coronary Angiography and Clinical Results ON TOPAZ, M.D., ELIEZER A. ROZENBAUM, M.D., MICHAEL G. LUXENBERG, PH.D., and AUDREY SCHUMACHER, R.N. From the Cardiac Catheterization Laboratory, Section of Cardiology, St. Paul Ramsey Medical Center, Universiv of Minnesota Medical School. St. Paul, Minnesota Laser-assisted coronary angioplasty can be successfully applied to lesions not ideal for balloon angioplasty. Patients with severely impaired left ventricular (LV)function and complex coronary artery stenoses who call for percuraneous revascularization are considered a high risk group for balloon angioplasty. In order to determine the feasibility, safety, and acute clinical outcome of a solid state, pulsed wwe, mid-infrared (2.1 micron) laser facilitated angioplasty in these patients. data from 112 patients with 129 lesions were analyzed. Patients were identified according to angiographic LV function; group I included 22 patients with left ventricular ejection fraction (LVEF) 5 4 0 % (mean = 25% -+ 10%) and group II included 90 patients with LVEF 2 40% (mean = 58% 5 8%). No diflerence in age, gender, diabetes, hypertension, tobacco use, history of previous coronary artery bypass surgery (CABGS) or percutaneous transluminal coronary angioplasty M'LLS registered between the two groups. Multivessel disease, previous myocardial infarction (MI), and severe angina were more prevalent among group Ipatients (P = 0.03). No dizerence was found in lesion location, complexity, length, or calcification between the two groups: although group I had more eccentric lesions. Both groups were treated with the same laser energy level followed by adjunctive balloon angioplasty. One hundred percent procedural success was obtained in group I versus 93% in group I1 (P = NS). By Q.C.A. (independent core lab), minimal luminal diameter increased in group :from 0.9 +- 0.5 mm preprocedure to 2.0 f 0.5, as compared to 0.8 5 0.5 mm to 1.9 2 0.5 mm (P = NS) in group II. Stenosis severity improved from 69% -t 16% preprocedure to 37% -t 13% postprocedure in group I, as compared to improvement from 78% 5 16% to 37% * 12.7% in group I1 (P = NS). Overall complication rate was remarkably low, with no death or perforation in either group: emergency CABGS 0% in group 1 und 1.1% in group I!; dissections 4.5% in group I and 8.8% in group 11. There was no significant diference in complication rate between the two groups. The results of this study suggest that holmium: YAG laser facilitated coronary angioplasty can be safely performed in patients with severe LV dysfunction, achieving a remarkably high procedural success and low complication rate. (J lnterven Cardiol 1995;8:661-669) Introduction The use of percutaneous transluminal coronary an- gioplasty (PTCA) in patients with depressed left ven- tricular (LV) function and suitable angiographic anat- Address for reprints: On Topaz, M.D., lnterventional Cardiovascular Laboratory, Division of Cardiology, McGuire VA Medical Center, Medical College of Virginia, 1201 Broad Rock Blvd., Richmond, VA 23249. Fax: (804) 230-1475. omy is increasing. Laser-assisted coronary angio- plasty has been recently introduced for treatment of lesions not ideal for balloon a n g i ~ p l a s t y . ~ ~ ~ Since pa- tients with depressed LV function and complex coro- nary artery stenoses are a potentially high risk group, a question arises whether laser-assisted balloon angio- plasty can facilitate acute angiographic and clinical outcome. The purpose of this communication is to re- port the feasibility, safety, and acute clinical outcome of ho1mium:YAG laser-assisted balloon angioplasty in patients with LV dysfunction. Vol. 8, No. 6, 1995 Journal of Interventional Cardiology 66 1

Transcript of Laser-Assisted Coronary Angioplasty in Patients with Severely Depressed Left Ventricular Function:...

Laser-Assisted Coronary Angioplasty in Patients with Severely Depressed Left Ventricular Function: Quantitative Coronary Angiography and Clinical Results

ON TOPAZ, M.D., ELIEZER A. ROZENBAUM, M.D., MICHAEL G. LUXENBERG, PH.D.,

and AUDREY SCHUMACHER, R.N.

From the Cardiac Catheterization Laboratory, Section of Cardiology, St. Paul Ramsey Medical Center, Universiv of Minnesota Medical School. St. Paul, Minnesota

Laser-assisted coronary angioplasty can be successfully applied to lesions not ideal for balloon angioplasty. Patients with severely impaired left ventricular (LV) function and complex coronary artery stenoses who call for percuraneous revascularization are considered a high risk group for balloon angioplasty. In order to determine the feasibility, safety, and acute clinical outcome of a solid state, pulsed w w e , mid-infrared (2.1 micron) laser facilitated angioplasty in these patients. data from 112 patients with 129 lesions were analyzed. Patients were identified according to angiographic LV function; group I included 22 patients with left ventricular ejection fraction (LVEF) 5 4 0 % (mean = 25% -+ 10%) and group II included 90 patients with LVEF 2 40% (mean = 58% 5 8%). No diflerence in age, gender, diabetes, hypertension, tobacco use, history of previous coronary artery bypass surgery (CABGS) or percutaneous transluminal coronary angioplasty M'LLS registered between the two groups. Multivessel disease, previous myocardial infarction (MI) , and severe angina were more prevalent among group Ipatients (P = 0.03). No dizerence was found in lesion location, complexity, length, or calcification between the two groups: although group I had more eccentric lesions. Both groups were treated with the same laser energy level followed by adjunctive balloon angioplasty. One hundred percent procedural success was obtained in group I versus 93% in group I1 (P = NS). By Q.C.A. (independent core lab), minimal luminal diameter increased in group :from 0.9 +- 0.5 mm preprocedure to 2.0 f 0.5, as compared to 0.8 5 0.5 mm to 1.9 2 0.5 mm (P = N S ) in group II. Stenosis severity improved from 69% -t 16% preprocedure to 37% -t 13% postprocedure in group I , as compared to improvement from 78% 5 16% to 37% * 12.7% in group I1 (P = NS). Overall complication rate was remarkably low, with no death or perforation in either group: emergency CABGS 0% in group 1 und 1.1% in group I!; dissections 4.5% in group I and 8.8% in group 11. There was no significant diference in complication rate between the two groups. The results of this study suggest that holmium: YAG laser facilitated coronary angioplasty can be safely performed in patients with severe LV dysfunction, achieving a remarkably high procedural success and low complication rate. (J lnterven Cardiol 1995;8:661-669)

Introduction

The use of percutaneous transluminal coronary an- gioplasty (PTCA) in patients with depressed left ven- tricular (LV) function and suitable angiographic anat-

Address for reprints: On Topaz, M.D., lnterventional Cardiovascular Laboratory, Division of Cardiology, McGuire VA Medical Center, Medical College of Virginia, 1201 Broad Rock Blvd., Richmond, VA 23249. Fax: (804) 230-1475.

omy is increasing. Laser-assisted coronary angio- plasty has been recently introduced for treatment of lesions not ideal for balloon a n g i ~ p l a s t y . ~ ~ ~ Since pa- tients with depressed LV function and complex coro- nary artery stenoses are a potentially high risk group, a question arises whether laser-assisted balloon angio- plasty can facilitate acute angiographic and clinical outcome. The purpose of this communication is to re- port the feasibility, safety, and acute clinical outcome of ho1mium:YAG laser-assisted balloon angioplasty in patients with LV dysfunction.

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TOPAZ, ET AL.

Methods

Study Patients. One hundred and twelve patients with a total of 129 coronary artery stenoses who under- went percutaneous coronary laser-assisted angioplasty were divided into two groups according to LV func- tion. One group included 22 patients with depressed angiographic LV ejection fraction (LVEF 5 40%) and the second group included 90 patients with preserved angiographic LVEF (LVEF 2 40%). Patients consid- ered for this procedure were those with symptomatic coronary artery disease and objective evidence of myocardial ischemia sufficient to warrant balloon an- gioplasty or coronary artery bypass surgery (CABGS), and angiographically documented stenoses of native coronary arteries or bypass grafts thought to be travers- able with angioplasty guidewires. The majority of pa- tients were referred for laser angioplasty, as their le- sions were not considered ideal for balloon angioplasty due to lesion morphology or location, previous unsuc- cessful attempt of balloon angioplasty, and/or multiple recurrences after balloon angioplasty. Patients with an evolving myocardial infarction who did not qualify to receive thrombolytics, or received lytic agents but clinically failed to respond, were considered for entry into the protocol. This study is part of a nonran- domized multicenter trial. Informed consent was ob- tained under a protocol approved by the Food and Drug Administration and the Institutional Review Board at St. Paul-Ramsey Medical Center. These cases comprised a group representing 26% of the total num- ber of balloon angioplasty procedures performed dur- ing this period.

Procedure Definitions. Lesion complexity was graded according to the classification of the ACC/ AHA Task Force’ as modified by Ellis et aL6 Laser success was defined according to the National Heart, Lung, and Blood Institute (NHLBI) criteria7 as pas- sage of the laser catheter through the stenosis and more than 20% reduction in the absolute minimal diameter stenosis. Procedural success was defined as final diam- eter stenosis of 50% or less after adjunct balloon an- gioplasty, and the absence of a major clinical compli- cation (death, Q wave or non-Q wave myocardial in- farction [MI], or need for CABGS) at any time during hospitalization.

Acute closure was defined according to Cook et a1.4 Coronary artery dissection was defined as either a radi- olucent area, oftentimes linear, within the coronary lumen during dye injection: parallel tracts or a double

lumen separated by a radiolucent area contrast outside the coronary lumen, but within the wall of the vessel, or spiral luminal filling defects.’~~ Coronary perfora- tion was defined as a persistent extravascular collec- tion of contrast medium beyond the vessel wall with a well-defined exit port,’” Myocardial infarction was defined as prolonged angina (> 30 min), total creati- nine kinase increased to greater than the upper limit of normal (confirmed by creatinine kinase-MB isoen- zyme increase), with electrocardiographic evidence of infarction (which was defined as either ST segment elevation, primary ST segment depression, or new, significant Q waves in 2 2 contiguous leads).

Angioplasty Protocol. Pretreatment medications consisted of oral aspirin (325 mg) and a calcium chan- nel blocker administered the night before and the day of the procedure. Conventional 8Fr or 9Fr guiding catheters were used. A standard angioplasty regimen of heparin (10,000 U intravenous bolus injection), in- travenous nitroglycerin drip (adjusted to systolic blood pressure) and intracoronary nitroglycerin (100 mcg) were given before baseline quantitative coronary cine- angiography was performed.

Laser Equipment and Procedure. A holmium: YAG (2.1 micron), solid state, pulsed wave laser gen- erator (Eclipse 2 100, Eclipse Surgical Technologies, Palo Alto, CA, USA) was used. The active medium is a cylindrical crystal of YAG (Yttrium; Aluminum; Garnet) doped with ions of the rare earth element hol- mium. This device emits pulses of 250 microseconds, pulse width 250-600 mJ/pulse, at a frequency of 5 Hz. If needed, the fluence can quickly be adjusted higher or lower without removal of the laser catheter from the coronary artery. Five sizes of multifiber laser catheters (Laser Prime, Eclipse Surgical Technolo- gies) were available: 1.2 mm (27 fibers, 75 microns each), 1.4 mm (40 fibers, 50 microns each), 1.5 mm (26 fibers, 100 microns each), 1.7 mm (49 fibers, 50 microns each), and 2.0 mm (12 fibers, 100 microns each). A 0.014” or 0.018” (0.036-cm or 0.046-cm, respectively) guidewire was separately advanced across the lesion into the distal coronary artery with its position fluoroscopically confirmed. A laser cathe- ter was advanced over the guidewire up to the target lesion. The common, traditional lasing technique, which includes continuous delivery of pulses while slowly advancing the catheter along the target lesion, was utilized only in the first 12 cases. In the following 100 cases, a “pulse and retreat” lasing technique was applied. I I With this technique, the operator delivers

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LASER ANGIOPLASTY IN DEPRESSED VENTRICULAR FUNCTION

only a small number of pulses, typically 8-12, and then retracts the laser catheter either back into the guiding catheter or into the proximal, large portion of the lased artery to permit unimpeded forward coronary blood flow. A 45- to 60-second pause is taken prior to the next lasing session to allow adequate coronary relaxation time. Contrast is injected for observation of the lasing site, and administration of intracoronary nitroglycerin is commonly used. A combination of tac- tile feedback and angiography is used to decide how many passes through the lesion are necessary. Once a laser catheter passes smoothly through the length of the lesion, no furthcr passes are attempted. After hol- mium laser application, balloon angioplasty was per- formed in 109 patients and directional atherectomy in three to maximally reduce the luminal stenosis. After overnight heparinization, all vascular sheaths were re- moved. Discharge medications included aspirin (325 mg/day), and other cardiac agents as indicated.

Quahtative and Quantitative Coronary Arteri- ography. Cineangiograms of all patients were re- viewed by the investigators for determination of lesion severity and complexity before and after laser treat- ment, and following adjunct balloon angioplasty. Using a valid method previously described,” quantita- tive analysis of coronary stenoses before and after las- ing angioplasty, as well as after balloon angioplasty, was performed in an independent core laboratory at Stanford University, Palo Alto, California.

Data Collection. Recorded data on clinical, angio- graphic, and procedural parameters included: age; sex; past medical history; Canadian Cardiovascular Society functional classification; location of treated vessel; preprocedural and postprocedural percent diameter stenoses; laser catheter size; laser energy output; num- ber of laser pulses emitted; use of adjunctive balloon angioplasty; and all complications. Clinical complica- tions recorded included death, CABGS, MI, cerebro- vascular accident, hematoma, and need for blood transfusion. Angiographic complications recorded in- cluded perforation, dissection, acute closure, thrombo- sis, spasm, and distal embolization.

Statistical Analysis. To determine baseline differ- ences between the groups with normal LV function and with depressed LV function, Chi-square analysis was used for categoric variables and Student’s t-test for continuous variables. All analyses were performed with standard statistical software (SPSS for OS/2 Re- lease 4.1, Chicago, TL, USA). All data are presented as mean value +- SD.

Results

Patients (Table 1). Ho1mium:YAG laser facilitated coronary angioplasty was attempted in I12 consecu- tive patients, of whom 22 had angiographic LVEF 5

40% (mean LVEF = 25% k lo%), and 90 who had preserved LVEF 2 40% (mean LVEF = 58% * 8.8%). No differences in age, gender, diabetes melli- tus, hypertension, tobacco use, history of previous CABGS, or previous balloon angioplasty were seen between the two groups. Multivessel disease, previous MI, and angina Class I11 and IV were significantly more prevalent among patients with depressed LV function (P = 0.03).

Lesions (Table 2). The 112 patients had a total of 129 lesions treated with holmium:YAG laser. No dif- ference was found in lesion location (vessel, ostium, bifurcation, total), complexity, length, or calcification between patients with depressed LV function and those with preserved ventricular function.

Patients with impaired LV function showed a trend toward increased likelihood of eccentric lesions (P =

0.046). By visual estimation, no difference in prepro- cedure stenosis severity was found between the two groups. However, by quantitative angiography, pa- tients with normal LV function had more significant

Table 1. Clinical Characteristics in 1 I 2 Patients

LVEF > 40 LVEE‘ <: 40 ( n = 90) (n = 22) P Value

~ ~~~

Age (yr) Male Previous CABGS Previous PTCA Multivessel disease Multivessel treated

during procedure Multilcsions treated

dining procedure Previous MI Angina Class

I I1 111 IV

Mean LVEF

58.9 ? 12.0 69 (76.7) 6 (6.7)

23 (25.6) 29 (32.2)

1 I (12.2)

19 (21.1) 22 (24.4)

7 (73) 16 (17.8) 36 (40) 31 (34.4)

57.5 ? x.1

61.7 ? 11.0 17 (77.3) 4 (IX.2) 2 (9.1)

13 (59.1)

7 (31.X)

10 (45.5) 13 (99.1)

4 (18.2) 2 (9.1) 2 (9.1)

14 (63.6) 25.4 ? 10.4

NS NS NS NS 0.019

0.002

0.019 0.00 I o m 9

< 0.0001

Data are expressed as mean ? SD or number (%) of patients.

CAUCS = Coronary artery bypass graft surgery;VEF = Left ven- tricular ejuection fraction; MI = Myocardial infarction; PTCA = Pcrcutaneous transluminal coronary angioplasty.

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Table 2. Angiographic Charlicteristics

LVEF > 40 (n = 99)

Vessel Location RCA 36 (36.4) LAD 46 (46.4) LCX 16 (16.2) SVG l( l .0)

A 2 (2.0) B1 19 (19.1) B2 57 (57.6) C 21 (21.2)

Lesion Type

Length (mm) 15.5 t 7.6 Ostial 6 (6.1) Eccentricity 52/92 (56.5) Calcified 17 (17.2) Total occlusion 16 (16.2) Bifurcation 3 (4.2) Adjunctive balloon 96 (97.0) Stenosis severity (VE) 94.2 2 6.0 Stenosis severity (QCA) 78 & 16 Minimal luminal

Energy (watts) 2.5 +- 0.5 diameter (mm) 0.8 t 0.5

LVEF < 40 (n = 30) P Value

~

5 (16.7) 20 (66.7) 2 (6.7) 3 (10)

1 (3.3) 3 (10)

24 (80) 2 (6.7)

13.6 +. 5.6 2/27 (6.9)

21/27 (77.8) 5 (16.7) 4 (13.3) 0 (0)

30 (100) 95.9 f 4.2

69 t 16

0.9 f 0.4 2.6 f 0.3

0.007

NS

NS NS

0.046 NS NS NS NS NS

0.033

NS NS

Data are expressed as mean f SD or number (%) of lesions

LVEF = left ventricular ejection fraction; QCA = quantitative coronary angiography; VE = visual estimation.

100%

80%

6 0 %

40%

20%

0%

Table 3. Procedural Success and Angiographic Results

LVEF > 40 LVEF < 40 (n = 99) (n = 30) P Value

Procedure success 92 (92.9) 30 (100) NS Final % stenosis (VE) 23.6 f 21.4 16 -C 10.7 0,011 Final % stenosis (QCA) 36 f 13 37 2 13 NS Final MLD (mm) 1.9 2 0.5 2.0 ? 0.5 NS

Data are expressed as number (%) of lesions.

LVEF = left ventricular ejection fraction; MLD = minimal luminal diameter; QCA = quantitative coronary angiography; VE = visual estimates.

stenoses (78% 2 16%) than those with depressed LV function (69% k 16%) (P = 0.033). Minimal luminal diameter (MLD) before the procedure was similar in the two groups (P = 0.719, NS). Adjunctive balloon angioplasty was performed in 97% of the lesions of patients with normal LV function, and in 100% of the lesions in patients with depressed LV function (P = 0.629, NS).

Clinical Success (Table 3). Depressed LV function did not decrease the likelihood of clinical success. Similar immediate success was achieved in 92 (93%) lesions in patients with preserved LVEF and in 30 (100%) of the lesions in patients with impaired LVEF (P = 0.433, NS). By quantitative angiographic analy-

T i I T I

Figure 1. Reduction of percent diameter stenosis by quantitative angiographic analysis in 22 patients with depressed LV function (LVEF < 40%) (solid line) versus 90 patients with preserved LV function (LVEF > 40%) (dotted line) before (pre-), and after (post-) laser angioplasty (laser) and balloon angioplasty (PTCA).

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L

...................................... ....*-.. I... . . . ~~.... ..................... '. 39*13

*. I

L

*. I -*. 8.1 . T ....... - (luantitative Mean yo ........................................... *,.. ........

18* 9 3 I * Visual Mean %

- 2.5 E E CI

.I- f 2.0

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E, 1.0

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m .- a 1.5 - m c .- 4 - .- .5 c

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I f 1 Std. Dev. _ _ _ _ -- Mean Diameter

0 ' Pre laser Post laser Post PTCA

Figure 2. Increase in MLD (mm) in 22 palienis with LVEF < 40% (solid lines) versus 90 patients with LVEF > 40% (dotted lines) by laser-assisted coronary angioplasty.

sis, the severity of' the stenosis improved from 78% ? 16% to 36'3% k 13% in patients with preserved LV function compared with an improvement of 69% k 16% to 37% 2 13% in patients with depressed LV function (P = 0.915, NS) (Fig. 1). Minimal luminal diameter increased from 0.9 2 0.4 mm (mean k SD) to 1.3 +- 0.6 mm by laser, and then to 2.0 k 0.5 mm by adjunct balloon angioplabty in patients with

depressed LV function. In those with preserved LV function, MLD improved from 0.8 Ifr. 0.5 mm (mean k SD) to 1.2 * 0.5 mm by laser and to 1.9 ? 0.5 mm (mean ? SD) by adjunct balloon angioplasty (Fig. 2). Statistically, there was no difference in the final MLD among the two groups (P = 0.328, NS). By visual estimation, a more significant improvement oc- curred among patients with depressed LV function

80% v)

v) 0

.- 60%

lz

G

.I- 5 40%

P

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T % ...... ....,..... ........ : ....,,.... .............................................................. .- .. -. I I I 69+16 \.%. .*. 1 I I ............... I ............................. LS. ..................................

4 4 . 5 a k i a I I 1

Figure 3. Comparison of reduction of percent diameter rknosis as estimated by visual assessment (dotted lines) versus quantitative angiographic analysis (solid lines) in 22 patients with LVEF < 40%.

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100%

80%

60%

v)

VI 0

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3;

G

c,

40%

& 20%

0%

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1 -

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21+16 I I

jt Visual Mean O h I I I -

Pre laser Post laser Post PTCA Figure 4. Comparison of reduction in percent diameter stenosis as estimated by visual assessment (dotted lines) versus quantitative angiographic analysis (solid lines) in 90 patients with LVEF > 40%.

(Fig. 3) than in those with normal LV function: 95.9% ? 4.2% to 16% ? 10.7% versus 94.2% ? 6% to 23.6% k 21.4%, respectively (P = 0.01) (Fig. 4).

Complications (Table 4). The overall rate of com- plications in this series was low. No significant differ- ence was seen between the two patient groups compar- ing the incidence of embolization, MI, abrupt closure, spasm, emergency CABGS, major and minor dissec- tions, perforation, and death. Figure 5 demonstrates successful laser-assisted angioplasty in a patient with markedly reduced LV function and Figure 6 depicts

Table 4. Procedural Related Complications

LVEF > 40 LVEF < 40 (n = 90) (n = 22) P Value

Embolization 1 (1.1) MI 2 (2.2) Abrupt closure 3 (3.3) Spasm 6 (6.7) Emergency CABGS I (1.1) Major dissection 1 (1.1) Minor dissection 7 (7.8) Perforation 0 (0) Death 0 (0)

Data are expressed as numhcr (%) of patients

CABG = Coronary artery bypass surgery; LVEF = Left ventricular ejection fraction; MI = Myocardial infarction.

the results of laser angioplasty in a patient with normal LV function.

Discussion

The solid state, pulsed wave, mid-infrared holmium laser is suited to rapid, highly targeted vaporization of plaque and/or thrombu~. '~ This investigational laser system is applied to patients with an approved protocol in a nonrandomized, observational multicenter study. The penetration depth along the coaxial guidewire is 500-500 micron; thus this laser can be applied as a noncontact laser, a feature most important in treatment of complex type and thrombotic lesions. To date, more than 1,500 patients have been treated. l4 Laser success was achieved in 87% of the lesions and final proce- dural success was 94%. The laser decreased the steno- sis from 89.6% ? 10.3% to 62.5% ? 21%, and ad- junctive balloon angioplasty achieved a final mean re- sidual stenosis of 21% ? 18.5%. Percutaneous coronary angioplasty is now increasingly used in com- plex and potentially high risk conditions. Such were our 22 patients with depressed LV function in whom revascularization was necessary despite increased risk. In this group of patients, coronary bypass surgery was not performed because surgical morbidity and mortal- ity was judged to be equal or in excess of the predicted

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Figure 5. A 65-year-old woman with severe angina. LVEF = 20%. with severe milral regurgilaliun, pulmonary hypertension, and chronic obstructive pulmonary disease. (A) Three lesions (each marked by an arrow) in the left anterior descending coronary artery (left anterior oblique [LAO] prqjection). (B) Right anterior oblique [RAO] view. (C) A 1.4-laser catheter at the first lesion. (D) Final results following adjunct balloon angioplasty. LAO cranial view. (E) Final results in RAO view.

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Figure 6. A patient with unstable angina caused by severe ostial posterolateral branch stenosis. (A) Stenosis marked by an mow. LVEF = 65%. (B) Results after application of laser-assisted angioplasty.

risk of coronary angioplasty. Our results further sub- stantiate recent favorable clinical experience with ap- plication of ho1mium:YAG laser to lesions not ideal for balloon angi~plasty.~, '~ The findings that low mor- tality and morbidity are associated with application of this debulking device in potentially high risk patients are encouraging.

Immediate Results. The immediate angiographic and clinical results were similar between patients who had LV dysfunction and those with normal LV func- tion. Hartzler et a1.16 reported a mortality rate of 2.7% among patients with depressed LV function (LVEF 5

40%), who underwent balloon angioplasty alone, while in the present series no deaths occurred. The major complications rate in our patients with LV dys- function was 0% compared to 4.4% in those with nor- mal LV function. Both rates are lower than that ex- pected in patients with normal LV function who undergo balloon angioplasty for complex type le- sions.'7 In a recent report on the results of balloon angioplasty in 61 patients with severely depressed LV function (LVEF < 35%), Kholi et a1.2 noted a major complications rate of 8.2%. The mean LVEF of their patients was 27% t 6%, which is very similar to the 25% 2 10% in our series. Stevens et al." reported a 4% mortality in 845 patients with a calculated or estimated EF of < 40%. To judge from a comparison of Stevens et al.'s'' data to the present data, it is con- ceivable that application of holmium laser prior to bal- loon dilatation reduces the rate of complications attrib- uted to balloon dilation. A different explanation for

the very low rate of mortality in the present series is that it represents results in a relatively small series of patients. However, multivessel angioplasty were per- formed in 31.8% of our patients, an incidence similar to the 33% of patients who underwent multivessel an- gioplasty by Kohli et a1.2

Of note, in the experience of the NHLBI registry,' emergency coronary bypass surgery was needed in 2.9%-4.3% of patients undergoing coronary angio- plasty, depending on the number of vessels involved. In our series, no patient with depressed LV function needed emergency CABGS: a finding in correlation with the experience of Kohli et a1.2

Similar to laser facilitated balloon angioplasty, other interventional techniques may assist and facili- tate angioplasty in patients with LV dysfunction. These include intra-aortic balloon counterpul~ation'~ and percutaneous cardiopulmonary bypass supported angioplasty. Two hundred twenty-six of the 801 pa- tients recently reported from the experience of the Na- tional Registry of Elective Cardiopulmonary Bypass Supported Coronary Angioplasty had an EF of I 20%, with a hospital mortality of 8.8%.*'

Long-Term Outcome. To date, no prospective, randomized trial is available on the results of balloon angioplasty versus CABGS in patients with multiple vessel coronary artery disease and depressed LV func- tion. Munger et aL2' retrospectively compared 166 pa- tients with an EF 5 40% who had balloon angioplasty to 166 patients with similar degree of LV dysfunction treated surgically. The survival rates of the surgical

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group were better than the rates in the balloon angio- plasty group: 1-, 3-, and 5-year survival rates of 88%, 83%, and 69% versus 85%, 77%, and 64%, respec- tively.

Stevens et a1.18 reported an 87% actuarial survival among 845 patients with depressed LV function at 1 year. It decreased to 69% at 4 years, and during a follow-up of 33.5 months, 15% of the patients required late CABGS, while 27% required repeat balloon an- gioplasty.

Conclusions

In conclusion, ho1mium:YAG laser facilitated coro- nary angioplasty can be performed in patients with severe LV dysfunction with a high degree of immedi- ate success and a remarkable low complication rate. The question as to whether it may affect the natural history of these patients remains open until data on long-term follow-up will become available.

AcknowledRrnenrs: The authors gratefully acknowledge the support of Laurie Topaz, Shirley McCray, and Michelle Martin in the prepa- ration of this manuscript.

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