Safety and cost effectiveness of combined coronary angiography and angioplasty

Safety and cost effectiveness of combined coronary angiography and angiopiasty If coronary angioplasty can be safely performed at the time of the initial diagnostic catheterization, it may result in shorter hospitalization stays and lower overall costs. Combined coronary angiography and angioplasty was performed electively on 733 patients between January 1, 1984, and September 1, 1988. These patients were divided Into three ma]or subgroups based upon their indications for angioplasty: 444 (61%) procedures were performed for restenosis; 190 (26%) procedures were performed in patients for unstable anglna; and 99 (13%) procedures were performed In patients without unstable anglna or previous angioplasty. A subset of 219 patients from this study who underwent elective combined coronary angiography and angloplasty durlng 1988 were compared with a matched population of 191 patlents from the same year who had elective angioplasty utlllzlng a traditional staged approach (coronary anglography and angioplasty as separate procedures). The success and complication rates were similar for both of these groups. Patients who underwent the combined procedure were hospitalized for a mean of 4.6 days with average total charges of $11,128, compared wlth 8.0 days and $13,160 for patients undergoing separate procedures @ > 0.001). Significant savings were also realized with respect to total contrast dose, fluoroscopic time, and total procedural tlme. Thus In informed patients wlth sultable coronary anatomy, the strategy of combined angiography an angloplasty may present an opportunlty for decreasing hospltallzation stay, reducing total charges for revascutarizatlon, and reducing radlatton exposure without compromising the safety or effectiveness of the procedure. (AM HEART J 1991;122:50.)

James H. O’Keefe, Jr., MD, Crosby Gernon, MD, Ben D. McCallister, MD, Robert W. Ligon, MA, and Geoffrey 0. Hartzler, MD. Kansas City, MO.

Previous reports1-4 have suggested that coronary angioplasty can be performed at the time of the initial diagnostic cardiac catheterization with success and complication rates similar to those observed with the conventional staged procedure. Many centers presently utilize simultaneous coronary arteriography and angioplasty in patients suffering acute infarction for reasons related to the time urgency of reestablishing infarct vessel patency.5 The emergence of elective combined coronary angiography and angioplasty in stable patients was prompted by assumptions that this approach might shorten hospital stays, maximize cardiac catheterization laboratory efficiency, and perhaps reduce the total cost of the procedure. Although coronary angioplasty at the time of the initial catheterization has been found to shorten hospital stay,l the actual cost of the combined proce-

From Luke’s Received

Cardiovascular Hospital. for publication

Consultants, Nov.

Inc., Mid 13, 1990;

Reprint requests: Ben D. McCallister, 4320 Wornall, Suite H-20, Kansas City, 4/1/29341

50

America

accepted

Dec.

MD, Cardiovascular MO 64111.

Heart

Institute,

28, 1990. Consultants,

St.

dure compared with the traditional staged procedure has not been reported. Furthermore, the previous trials examining combined angiography and angioplasty have been relatively small and have not addressed the feasibilty of this strategy in the various subgroups of patients undergoing elective angioplasty. The present study was performed to determine (1) the safety and efficacy of combined coronary angiography and angioplasty; (2) the actual dollar savings realized by combining the procedures; (3) the results in the three major subgroups of patients with restenosie, unstable angina, and stable patients without prior angioplasty; and (4) the effect of combining procedures on contrast dose, fluoroscopy time, total catheterization laboratory time, and other procedural variables. METHODS Patient

population. In this retrospective study, information wasobtained through detailed review of (1) in-hospital and outpatient charts, (2) cineangiogramsand catheterization reports, and (3) the computer data baseof all patients undergoing coronary angioplasty at our institution. Follow-up information was obtained through mailed

Volume122 Number 1, Part

Table

Combined

1

angiography

I. Patient characteristics

and PTCA

51

__Class

Repeat

IV

t1i -.;X:! ‘i$” pl:‘,

Elective

--

Procedures Male/Female

190 72 %I /28 16

444 80%/20%

99 87 5 113 7;.

Mean age (yr) Age 2 70 yr LVEF 5 40% Prior CABG

62 54 (28% ) 29 (15RB) 31 (16/j

60 78 (17%) 45 (10%) 114 (26/)

56 11 (11%) 15 (15%) 19 (19/)

PM1 Diseased 1 2 3

94 (49%)

‘240 (54%

85 (45%) 54 (28%) 51 (27%)

175 (39%) 147 (33%) 122 (28%)

)

64 (65”;

1‘43 $9 164 3%

)

a: 12o~;N I (12”; 1 (“2’-‘;, 1 ( 54”;, 1

vessels

Angina class I II III IV SL PTCA ML PTCA LVEF, Left ventricular transluminal coronary

190 97 93

50 110 88 196 203 241

49 (49 70 ) 30 (30%) 20 (21%)

30~~ i 4 2 ‘7 ) y: (.J.)‘7’ I c (8 ) Iy’ i’l6”; \

47 23 29 -54 45

9’7 Iq

ejection fraction; CABG, coronary artery bypass graft; PMI, previous myocardial infarction; angioplasty; ML PTCA, multilesion percutaneous transluminal coronary angioplasty.

questionnaires, repeat hospitalization, clinic visits, and supplemental telephone interviews. Six thousand eighty-four elective coronary angioplasty procedureswere performed between January 1, 1984, and September 1,1988. Coronary angioplasty wasperformed at the time of the initial diagnostic catheterization in 733 procedures(12%) during this period. Patients undergoing direct coronary angioplasty for an acute myocardial infarction were excluded from this study. The 733 total procedures were divided into three major subgroups based upon their indications for angioplasty. In 444 procedures (61%) the combined procedure was performed for restenosisfollowing a previous angioplasty. Unstable angina (defined as angina1discomfort at rest) wasthe indication in 190 procedures (26%), and 99 procedures (13% ) were performed on a purely elective basis in patients without unstable angina or previous coronary angioplasty. The demographic features of the total study population aswell as those of the three subgroupsare summarized in Table I. A subset of 219 consecutive patients who underwent combined coronary angiography and angioplasty during 1986was analyzed in detail and was compared with 191 consecutive patients from the sameyear who underwent elective angioplasty asa traditional stagedprocedure. The comparative characteristics of these two groups are outlined in Table II. Definitions. Combined coronary angiography and angioplasty was defined as the performance of both procedures during the samesetting. Coronary angioplasty performed later in the sameday after cineangiographic film review, or on a subsequentday but during the samehospital admission,was considered a staged procedure. Successfulcoronary angioplasty wasdefined as a reduction of the dilated lesion to 150% obstruction without a major in-hospital complication. Major complications in-

IiT

SL PTCA,

:Wj 354 479 ._ single-lt+n percutaneous

eluded: in-hospital death, emergency coronary artery bypass graft surgery, or transmural myocardial infarction (defined asthe appearanceof new Q waves~1 mV, with an elevated creatine phosphokinase(CPK) and positive MB isoenzymefractions). Multivessel coronary diseasewasdefined asthe presenceof a stenosisof ?70?’ in two or more major coronary artery systems. Economic data. Complete, detailed analysesof patient chargeswere performed for the two groupsof patients undergoingeither a traditional stagedprocedure or combined angiography and angioplasty during 1986. In-hospital chargesincIuded all those incurred during hospitalization. Physicians’ feesincluded professionalchargesand all outof-hospital expensesincurred during the pre-hospitalization work-up and for the first 30 days after hospital discharge. Procedure. Informed consent for both procedureswas obtained prior to the angiogram,usually on the day before the procedure. The decision to proceed with angioplasty wasbasedon the videotaped fluoroscopic images.Surgical back-up for emergency bypass grafting was routineIy available and did not require pre-angioplasty surgical consultation or clearance.The x-ray imaging equipment utilized in our cardiac catheterization laboratories is manufactured by General Electric (LU/C arm, High Resolution Systems,with an advanced imagingchain and programmed automatic iris; GE Medical Systems, Milwaukee, Wise.). Angiographic stenosismeasurementswere obtained using an electronic caliper (Mitutoyo No. 500-215)allowing for accurate measurementsto 0.01 mm. Stenosis measurements were made in at least two orthogonal views. RESULTS

Primary angiographic of the 733 combined

success was achieved in 95 % coronary angiography and

52

O’Keefe et al

Table

American

II. 1986 cohorts Combined

Staged procedures

procedures

Procedures Age Prior CABG PMI LVEF i 40% Age > 70 years Angina class I II III IV Diseased vessels 1 2 3

219 61 53 (24%) 123 (56%) 29 (13!z) 46 (21%) 21 38 32 128

(9.6%) (17%) (15%) 68%)

81 (37%) 73 (33 7;s) 65 (30%)

19 62 22 51

190 63 (10%) (33%) (11%) (27%)

NS NS p 5 0.001 NS NS

36 50 28 77

(19%) (26%) (15%) (41%)

p 5 0.001

40 (21% ) 84 (44%) 67 (35%)

p = 0.002

NS, Not significant, p < 0.05; Prior CABG, prior coronary artery bypass graft surgery; other abbreviations as in Table I.

Table

ill. Complications Patients

Total Restenosis Unstable angina Elective

733 444 190 99

Deaths

6 2 3 1

(0.8T*) (0.5%)* (1.6%)* (1.0%)

MI

10 6 3 1

(1.4) (1.4) (1.6) (1.0)

CABC

19 10 5 4

(2.6) (2.3) (2.6) (4.0)

Abbreviations as in Table I *p = 0.30.

angioplasty procedures. The angiographic success rates in the three major subgroups were (1) restenosis procedures = 96%) (2) unstable angina procedures = 93%) (3) elective procedures = 95% (p = 0.86). Complications for the total study population and the three major subgroups are detailed in Table III. OveraII mortality was 0.8 % ; the lowest in-hospital mortality was observed in patients undergoing angioplasty for restenosis (0.5%), although this difference did not reach statistical significance. The inhospital mortality rates for the total study group were significantly increased in patients with a left ventricular ejection fraction 540 % (3.4 % ), and for those with three-vessel coronary artery disease (2.6%). Cineangiographtc

review.

Cineangiographic

films

were available for review in 88 of the 99 purely elective combined procedures. Quantitative angiographic measurements revealed two cases in which the operator was apparently misled by the videotaped images. In both cases a lesion of ~50% luminal diameter stenosis was mistakenly judged on the videotape image review to the significant and was subsequently

July 1991 Heart Journal

dilated. No adverse consequences were noted in the two cases. Follow-up. Complete follow-up was available in 97% of patients; mean duration of follow-up was 27 months. Forty-three late deaths were noted (7%); late coronary artery bypass graft surgery was required in 80 patients (12 % ). At the end of follow-up, 64% of patients remained angina-free. The l-year survival for patients who underwent combined coronary angiography and angioplasty was 98%. Oneyear event-free survival (defined as freedom from death, transmural myocardial infarction, and coronary bypass graft surgery) was 86% in patients who underwent the combined procedure. 1986 Cohorts. Cost analysis was performed for 219 patients who underwent combined coronary angiography and angioplasty during 1986 and for 191 patients who underwent a traditional staged procedure during the same year. These two cohorts were similar in most respects, although patients who underwent the combined procedure were more likely to have suffered a previous myocardial infarction, have unstable angina, and have three-vessel coronary artery disease (Table II). The success rates and complication rates were similar in both groups of patients (Table IV). Procedural variables for the two 1986 cohorts are listed in Table V. Patients who underwent the combined procedure had shorter hospital stays, averaging 2.4 days less than the stays of those who underwent the traditional staged procedure. Total costs including charges for the pre-procedural work-up, hospital charges, professional fees, and related expenses for up to 30 days following angioplasty were $2032 lower in those who underwent the combined procedure. Total time spent in the cardiac catheterization laboratory was shortened by 37 % , and the total contrast agent load was 93 ml less in those who underwent combined coronary angiography and angioplasty. All of these differences in procedural variables between the two groups achieved statistical significance. DISCUSSION

A recent American College of Cardiology/American Heart Association task force position paper6 stated that coronary angioplasty should not be performed at the time of the initial diagnostic catheterization because of concerns about patient preparedness and safety, surgical back-up and scheduling, and videotaped image quality. However, the results of this study have established combined coronary angiography and angioplasty as a safe and effective option for coronary revascularization in selected pa-

Volume Number

122 1, Part

Combined

1

tients. The performance of angioplasty at the time of the initial catheterization did not affect procedural morbidity and mortality, it shortened hospitalization time by 30%, and it reduced total costs of the procedure by 15%. Significant reductions in (1) total radiation dose to both patient and operator, (2) contrast agent load, and (3) total catheterization time were also realized by combining the procedures. Patients who have undergone prior angioplasty and who are being evaluated for possible restenosis have coronary anatomic findings that have been previously documented and thus decisions relating to therapeutic options can usually be made prior to the catheterization. It is our practice to perform combined coronary angiography and angioplasty in these patients unless 1 year or more has elapsed since the last cardiac catheterization. In patients without a recent angiogram, the frequent progression of disease in nondilated segments renders it difficult to anticipate the coronary anatomy,7-g and these patients may be best treated using the traditional staged approach. Patients presenting with episodes of rest angina are at high risk for cardiac events’* and will usually have at least one high-grade stenosis present at angiography.‘l If relatively simple coronary anatomy is noted at the time of catheterization, angioplasty can be performed at the same time, permitting prompt stabilization of the patient and ensuring a shorter hospital stay. Complication and mortality rates of combined angiography and angioplasty trended higher (although not significantly so) in patients with unstable angina. This is consistent with previous data that showed higher complication rates in unstable angina patients than in those with stable angina when both groups were undergoing angioplasty in a conventional staged procedure.12 Patients presenting with stable angina without previously documented coronary anatomy can also be considered for combined angiography and angioplasty. Younger patients without previous cardiac events may be ideal for the combined strategy, as they are more likely to have relatively simple coronary pathoanatomy. Aspirin therapy is very effective in preventing acute closure and in-hospital cardiac events after coronary angioplasty. I’* l4 Pretreatment with aspirin has been found to be most effective,15 and thus if combined coronary angiography and angioplasty is being considered, the patient should be started on aspirin at least 1 day before the procedure. If urgent angiography and angioplasty is required in a patient not pretreated with aspirin, a 325 mg tablet of aspirin, chewed and swallowed, results in nearly maximal antiplatelet effects within 15 minutes of ingestion.16

an&pa&y

53

and PTCA

Table IV. 1986 cohorts Combined procedures

Procedures Success Mortality MI Emergency CABG Abbreviations

Staged procedl> rcs

P

n = l:tO ~YiI ” t: 0 ,.5’ 0 .I5’

il.99 0.50 0.99 0.21

n = 7.19 94 “i 0.5”; 0.9 “it 2.3”;

as in Table I

Table V. Procedure variables Combined procedures (n = 219)

Hospitalization time Hospital charges Physician fees Total charges* Fluoroscopy time Contrast utilized Procedural time *In-hospital

StagI’d procedures in = ISOJ

5.6 days $7,840

P

8.0 days $9,1X0


$3,288

$3,930


$11,128 24 min 206 ml 94 min

$13.160 33 m in


%99 ml


150 rnin


and 30-day post-angioplasty

charges

Clearly, the combined strategy is not appropriate for all patients requiring coronary angioplasty. Noncomplex coronary pathoanatomy, for example, discrete lesion single- or double-vessel disease, is probably most appropriate for this approach. Procedural risks are increased in patients with complicated coronary anatomy, and it is logical to defer elective angioplasty in these patients to allow an unhurried review of the cineangiograms and surgical consultation, if necessary. High-fidelity Auoroscopic and video replay images are essential to the safe performance of combined angiography and angioplasty. The assessment of coronary anatomy based solely on videotaped images rarely impaired the cardiologist’s ability to judge lesion severity in the present study. However, interpretation of videotaped images did result in overestimation of stenosis severity in two cases. For this reason, if a lesion is considered borderline (50% to 70 % ), angioplasty should be deferred until after the cardiologist has reviewed the cineangiographic films. Recent developments in imaging chain technology for the recording and playback of coronary angiography have improved the fidelity of videotaped images and may prove to be very useful in the setting of combined coronary angiography and angioplasty.17! l8 If coronary angioplasty is to be performed in conjunction with the diagnostic catheterization, the

54

O’Keefe et al

physician must explain the risks and goals and obtain informed consent from the patient for both procedures prior to the study. Informed consent should not be obtained at the end of the diagnostic catheterization when the patient is usually sedated and may be psychologically distressed. Combined cardiac catheterization and angioplasty requires flexible surgical coverage to allow for emergency bypass surgery in the event of abrupt refractory coronary occlusion or other procedure-related complications. The risk of angiographic contrast-related nephropathy has been shown to be increased in patients receiving high doses of contrast agent and in those requiring multiple procedures within 48 to 72 hours.lg, 2o Although the amount of contrast utilized was higher in those undergoing combined angiography and angioplasty than in either of the two separate procedures, the overall dose required for percutaneous revascularization was decreased. In a previous similar report,l the incidence of post-angioplasty renal failure was not increased in patients with combined angiography and angioplasty. Economic considerations have resulted in the growing trend toward the use of outpatient cardiac catheterization.z1 Similar measures have also been suggested for coronary angioplasty in an attempt to control costs.22 Over $2000 per patient was saved in the present study by combining coronary angiography and angioplasty, without compromising procedural safety or results. A potential problem with the performance of angioplasty as an extension of the initial diagnostic catheterization in the possibility of dilating a lesion that appears significant without carefully considering the clinical milieu and other therapeutic options available. This can be avoided if (1) the interventional cardiologist and a colleague consult before the angioplasty is performed and (2) a specific strategy contingent upon angiographic results is formulated prior to proceeding with cardiac catheterization. Conclusion. In informed patients with suitable coronary anatomy, the strategy of combined angiography and angioplasty may present an opportunity for decreasing hospital stay, radiation exposure, and total cost of revascularization without compromising the safety or effectiveness of the procedure.

American

3.

4.

5.

6.

7.

8.

9.

10. 11.

12.

Heart

July 1991 Journal

Myler RK, Startzer SH, Clark DA, Shaw RE, Fishman-Rosen J, Murphy MC. Coronary angioplasty at the time of initial cardiac catheterization: “ad hoc” angioplasty possibilities and challenges. Am J Cardiol 1986;12:213-4. Alfonso F, Macaya C, Iniguez Z, Zarco P. Repeat coronary angioplasty during the same angiographic diagnosis of coronary restenosis. AM HEART J 1990;119:237-41. O’Keefe JH Jr, Rutherford BD, Mcconahay DR, et al, Early and late results of coronary angioplasty without antecedent thrombolytic therapy for acute myocardial infarction. Am J Cardiol 1989;64:1221-30. Ryan TJ, Faxon DP, Gunnar RM, et al. Guidelines for percutaneous transluminal coronary angioplasty. Circulation 1988;78:486-502. Bottner RK, Green CE, Ewels CJ, Recientes E, Patrissi MA, Kent KM. Recurrent &hernia more than one year after successful percutaneous transluminal coronary angioplasty. Circulation 1989;80:1580-4. Shub C, Vlietstra RE, Smith HC, et al. The unpredictable progression of symptomatic coronary artery disease. Mayo Clin Proc 1981;56:155-60. Cequier A, Bonan R, Crepeau J, Cote G, DeGuise P, Joly P, Lesperance J, Waters DD. Restenosis and progression of coronary atherosclerosis after coronary angioplasty. J Am Co11 Cardiol 1988;12:49-55. Parisi AF, Khuri S, Deupree RH, Sharma GV, Scott SM, Luchi RJ. Medical compared with surgical management of unstable angina. Circulation 1989;80:1176-89. Alison HW, Russell RO, Mantle JA, Kouchoukos NT, Moraski RE, Rackley CE. Coronary anatomy and arteriography in patients with unstable angina pectoris. Am J Cardiol 1978; 41:204-8. Holmes DR, Holubkov R, Vlietstra RE, et al. Comparison of complications during percutaneous transluminal coronary angioplasty from 19’77 to 1981 and from 1985 to 1986: the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty registry. J Am Co11 Cardiol 1988;12:1149-55.

13. Schwartz L, Bourassa MG, Lesperance J, et al. Aspirin and dipyridamole in the prevention of restenosis after percutaneous transluminal coronary angioplasty. N Engl J Med 1988; 318:1714-9.

14. Chesebro JH, Webster MW, Reeder GS, et al. Coronary angioplasty: antiplatelet therapy reduces acute complications but not restenosis. J Am Co11 Cardiol 1989;80:11-64. 15. Barnathan ES, Schwartz JS, Taylor L, et al. Aspirin and dipyridamole in the prevention of acute coronary thrombosis complicating coronary angioplasty. Circulation 1987;76:12534.

16. Jiminez AH, Stubbs ME, Tofler GH, Winther K, Muller JE. Rapid suppression of platelet aggregability and thromboxane Az production by chewed enteric-coated aspirin [Abstract]. J Am Co11 Cardiol 1989;80:11-352. 17. Grav JE. Wondrow MA. Smith HC. Holmes DR Jr. Technical considerations for cardiac laborotory high-definition video systems. Cathet Cardiovasc Diagn 1984;10:73-86. 18. Holmes DR Jr, Bove AA, Wondrow MA, Gray JE. Video x-ray progressive scanning: new technique for decreasing x-ray exnosure without decreasing image quality during cardiac catheterization. Mayo Clin Proc 1986;61:32i-6. 19. Taliercio CP. Vlietstra RE. Fisher LD. Burnett JC. Risks for renal dysfunction with cardiac angiography. Ann Intern Med 1986;104:501-4.

REFERENCES

O’Keefe JH Jr, Reeder GS, Miller GA, Bailey KR, Holmes DR Jr. Safety and efficacy of percutaneous transluminal coronary angioplasty performed at time of diagnostic catheterization compared with that performed at other times. Am J Cardiol 1989;63:27-9. Feldman RL, MacDonald RG, Hill JA, et al. Coronary angioplasty at the time of initial cardiac catheterization. Cathet Cardiovasc Diagn 1986;12:219-22.

Cigarroa RG, Lange RA, Williams RH, Hillis LD. Dosing of contrast material to prevent contrast nephropathy in patients with renal disease. Am J Med 1989;86:649-52. 21. Block PC, Ockene I, Goldbert RJ, et al. A prospective randomized trial of outpatient vs inpatient cardiac catheterization. N Engl J Med 1988;319:1251-5. 22. Cragg DR, Friedman HL, Almay SL, et al. Early hospital discharge after percutaneous transluminal coronary angioplasty. Am J Cardiol 1989;64:1270-4. 20.