BRIEF REPORTS

Supported Coronary Angioplasty and Standby Supported Coronary Angioplasty for High-Risk Coronary Artery Disease Carl L. Tommaso, MD, Rodney A. Johnson, MD, J. and Robert A. Vogel, MD

Lawrence Stafford, MD, Albert R. Zoda, MD,

D espite advances in technology and experience, there continues to be an appreciable acute closure raterm3

associated with percutaneous transluminal coronary an- gioplasty (PTCA). Hemodynamic compromise may also occur when a wire or balloon is advanced across or inflat- ed in a strategically located vessel. Therefore, in high-risk patients, techniques are necessary to enable support of the coronary or systemic circulation, or both, should he- modynamic collapse occur. Prophylactic coronary sup- port strategies have included coronary sinus retroperfu- sion4 and regional coronary perfusion of blood5y6 or oxy- genated fluorocarbons.’ The intraaortic balloon pumps and percutaneous cardiopulmonary bypass9J0 have been advocated to support the systemic circulation during high-risk interventional procedures or crises during more routine invasive procedures.

The purpose of this report was to relate our experience using supported coronary angioplasty (PTCA with per- cutaneous cardiopulmonary bypass) and to compare it to a similar group of patients undergoing PTCA when the cardiopulmonary bypass system was not inserted but used as standby. This comparison will serve to (1) de- scribe morbidity of these procedures, (2) define indica- tions for percutaneous cardiopulmonary bypass use dur- ing PTCA, and (3) demonstrate the safety of expectant percutaneous cardiopulmonary bypass use.

Since December 1987, we have used supported angio- plasty (S-PTCA) for very high-risk patients undergoing PTCA. S-PTCA utilizes percutaneous cardiopulmonary bypass initiated prophylactically before performance of coronary angioplasty. We have alsoperformed PTCA on a clinically and angiographically similar group of pa- tients who were evaluated andpreparedfor percutaneous cardiopulmonary bypass, but the cannulas were inserted only in the event of hemodynamic collapse. We have termed this latter group standby supported angioplasty (SB-PTCA). The patients underwent angiographic eual- uation and instrumentation of the contralateral (to the PTCA site) femoral artery and vein with small bore catheters, with percutaneous cardiopulmonary bypass equipment and personnel available.

From the Division of Cardiology, Department of Medicine, University of Maryland School of Medicine, 22 South Greene Street, Baltimore, Maryland 21201; and Suite 524, Division of Cardiology, Northwestern Memorial Hospital, 250 E. Superior Street, Chicago, Illinois 60611. Dr. Tommaso’s current address is: Section of Cardiology, Veterans Admin- istration Lakeside Medical Center, 333 E. Huron Street, Chicago, Illinois 60611. Manuscript received February 12, 1990; revised manu- script received and accepted July 11, 1990.

Definition of high-risk coronary artery disease was the same in both PTCA and SB-PTCA groups: (I) se- vere or unstable angina with 21 approachable target vessels with 275% diameter stenosis, and left ventricular ejection fraction 12570, or (2) >50% of the viable left ventricular myocardium jeopardized by a target lesion.

Angina1 symptoms were graded according to the Ca- nadian Heart Association classification. Heart failure was graded according to the New York Heart Associa- tion classification. The percent luminal diameter steno- sis was determined visually using a caliper and compar- ing the target lesion to a proximal segment judged repre- sentative of ‘izormal” caliber. Left ventricular ejection fraction was determined by contrast or radionuclide an- giography. The extent of territory supplied by the target

TABLE I Comparison of Patients Undergoing Supported and

Standby Supported Angioplasty

Standby Supported Supported Angioplasty Angioplasty p Value

No. of pts. 14 13

Age (yrs) 58f 11 66i12 <0.05 Sex 12men 9 men Angina

class* Ill 2 1 class IV 12 12 NS

CHF Class+ t III 7 5 5 II 7 8 NS

LVEF (%) 26f13 26i9 NS No. of coronary arteries

narrowed >50% in diameter Three 7 7 Two 4 5 One 1 LMCA 2 1 NS

Vessels attempted 18 13 Successful 16 13

% Stenosis Pre/post 93f5/ 92f4/ NS

25f15 24+8 Mortality NS

Procedural 2 0 Late 0 1

Morbidity NS Transfusion 8 1 GI bleed 1 0 Femoral vein 1 0

thrombosis Femoral bleed 1 0 Late reocclusion 1 0

- * Canadian Heart Association class. t New York Heart Association class. CHF = congestive heart failure; GI = gastrointestinal: LMCA = left main coronary

artery dilated; LVEF = left ventricular ejection fractton; NS = not significant: PTCA = percutaneous transluminal coronary angioplasty.

THE AMERICAN JOURNAL OF CARDIOLOGY NOVEMBER 15, 1990

vessel was determined by consensus of 2 angiographers. In all cases where the indication was >.50% of the myo- cardium jeopardized, the target vessel supplied collater- als to another coronary artery with a proximal chronic total occlusion considered not amenable to balloon PTCA. These indications were based on the likelihood of hemodynamic collapse occurring should flow in the ves- sel cease by acute closure or during balloon inflation.

Our experience detailed in this report reflects consec- utive, not randomized, patients during our initial experi- ence with S-PTCA. When the significant morbidity asso- ciated with insertion of the cannulas was recognized, we switched to a strategy of SB-PTCA in the subsequent consecutive patients with similar indications.

Data are reported as mean f standard deviation. Statistical analysis comparing data from S-PTCA

and SB-PTCA groups was done using Student’s t test and the chi-square method. A p value X0.05 was consid- ered statistically significant.

Fourteen patients (12 men and 2 women, mean age f standard deviation 58 f 11 years) underwent S-PTCA. Results are listed in Table I.

The SB-PTCA group consisted of 13 patients (9 men and 4 women, mean age f standard deviation 68 f I I, p KO.05; difference not significant [NS]).

Twelve patients in the S-PTCA group had Canadian Heart Association class Wand 2 patients class III angi- na. Seven patients had New York Heart Association class III or IV, and 7patients had class I or II congestive heart failure. Mean left ventricular ejection fraction was 26 f 13%.

In the SB-PTCA group, I patient had class III and I2 class IV angina (p = NS). Five patients had class III or IV, and 8 had class I or II congestive heart failure (p = NS). Mean ejection fraction of the SB-PTCA group was 26 f 9% (p = NS).

In the S-PTCA group, 2 patients had left main coro- nary artery stenosis, seven 3-vessel disease, four 2-ves- se1 disease and one l-vessel disease. Of the SB-PTCA group, I patient had left main stenosis, seven 3-vessel disease and five 2-vessel disease (p = NS).

The preangioplasty percent luminal diameter steno- sis was similar in both groups (S-PTCA 93 f 3% us SB- PTCA 92 f 4%,p = NS). Results after angioplasty were similar (25 f 15% us 24 f 8% respectively).

In 14 patients undergoing S-PTCA, cardiopulmo- nary bypass support was inserted by cutdown in IO and percutaneously in 4. Mean flow rate was 4.5 litersjmin and mean duration was 49 minutes. Ten patients had angioplasty by way of the femoral artery and 4 by way of the brachial artery.

In the S-PTCA group, 18 arteries were attempted (1.3 arteries per patient), with 16 vessels successfully dilated. Thirteen of the 14 patients had their target arteries successfully dilated. There were 2 deaths: 1 due to superior mesenteric artery thrombosis, and the other death occurred after dilation of an unprotected left main coronary artery in a patient with a history of bypass surgery. Dissection and thrombus occurred after dilata- tion and a satisfactory result could not be obtained.

1256 THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 66

Coronary bypass was performed but she diedperiopera- tively due to uncontrollable bleeding.

Of the other 12 S-PTCA patients, I patient had gas- trointestinal bleeding and was treated with antacids and histamine blockers. One patient required reexploration of the cannula insertion site for bleeding. Eight patients required transfusions. One patient developed acute clo- sure of a nontarget vessel 36 hours after the procedure and had a successful emergency redilatation.

In the 13 SB-PTCA patients, 13 vessels were at- tempted, all successfully. No patient developed vascular problems or required transfusion. No patient required insertion of percutaneous cardiopulmonary bypass be- cause of hemodynamic collapse or acute closure dun’ng the procedure. One patient died suddenly several days after successful PTCA when he suddenly developed chest pain, electrocardiographic changes and rapid he- modynamic deterioration, presumably due to late acute closure of the dilated vessel.

The amount of jeopardized myocardium and left ven- tricular function before PTCA appear to be strong indi- cators of PTCA risk. Hartzler et aI9 reported a 2.6% procedural mortality in a group of patients with large amounts of jeopardized myocardium.g Other data sug- gest that there is 2.7% procedural mortality in patients with left ventricular ejection fraction <40%.2

Patients considered at high risk for PTCA are often treated with prophylactic insertion of an intraaortic bal- loon pump.8 Others have explored the use of coronary sinus retroperfusion4 and the anterograde perfusion of blood,5,6 drugs or oxygenated fluorocarbons7 via the dila- tation catheter. Many of these methods have the disad- vantage that the dilatation catheter must be passed across the lesion for therapy or sufficient systemic pressure must be present to provide coronary perfusion.

We report a group of high-risk patients undergoing PTCA in whom the angioplasty was performed under the cover of percutaneous cardiopulmonary bypass (support- ed angioplasty). When it became apparent that there was a high incidence of vascular complications, and we were able to deploy percutaneous cardiopulmonary support rapidly, we began to perform SB-PTCA.

The use of partial cardiopulmonary bypass support during angioplasty appears to be very effective in sup- porting the systemic circulation. Segmental myocardial function, however, may not be spared and left ventricular segments supplied by target vessels may become abnor- mal during balloon inflation.

As demonstrated by this study, it appears that S- PTCA is feasible when performed by interventionalists familiar with the percutaneously inserted cardiopulmo- nary support device. Data from the supported angioplasty registry have defined success and complication rates in a larger group of patientslO

The present study demonstrates that the initial indica- tions for S-PTCA (i.e., left ventricular ejection fraction 125%, or target vessels supplying >50% of the myocardi- urn) are too liberal. Despite the similar precarious coro- nary anatomy and poor left ventricular function of the SB-PTCA cohort, no patient required percutaneous car-

diopulmonary bypass during the procedure. High-risk patients can be managed with SB-PTCA, thus, it is the preferred approach for most patients.

The lack of randomization of these patients weakens this study; however, randomization in the face of such high incidence of vascular problems may no longer be justified, since these patients did well without any system- ic support.

We conclude that active S-PTCA should be reserved for patients who have sustained prior hemodynamic col- lapse during an invasive procedure, or in whom PTCA is aimed at the only patent vessel, or in patients who have exceedingly low left ventricular ejection fraction (< 15%).

Acknowledgment: We thank Sheila Askew for her sec- retarial assistance, Nancy Tommaso for her editorial as- sistance, the catheterization lab nurses and technicians and the perfusionists of the University of Maryland for their support.

1. Mock MB, Holmes DR. Vlietstra RE, Gcrsh BJ, Detre KM, Kelsey SF, Orszulak TA, Schaff HV, Piehler JM, Van Raden MJ, Passamani ER, Kent KM,

Gruentzig AR. Percutaneous transluminal coronary angioplasty (PTCA) in the elderly patient: experience in the National Heart, Lung, and Blood Institute PTCA Registry. Am J Cardiol 1984;53:89C-91C. 2. Al-Bassam M, Leon M, Robertson T, Passamani E. Percutaneous transluminal coronary angioplasty in 1985-1986 and 1977-1981. The National Heart, Lung, and Blood Registry. N Engl J Med 1988;318:26S-270. 3. Cowley MJ, Dorros G, Van Raden M,‘Detre KM. Acute coronary events associated with percutaneous transluminal coronary angioplasty. Am J Cardiol 1984;53:17C-21C. 4. Zalewski A, Goldberg S, Slysh S, Maroko PR. Myocardial protection via coronary sinus interventions: superior effects of arterialization compared with intermittent occlusion. Circulation 1984;71:1215-1223. 5. Lehman” KG, Atwood JE, Snyder EL, Ellison RL. Autologous blocd perfusion for myocardial protection during coronary angioplasty: a feasibility study. Circu- lation 1987;76:312-323. 6. Stack RS, Quigley PJ, Collins G, Phillips HR. Perfusion balloon catheter. Am J Cardiol 1988;61:77F-806. 7. Cleman M, Jaffe CC, Wohlgelernter D. Prevention of ischemia during percuta- ncous transluminal coronary angioplasty by transcatheter infusion of oxygenated Fluosol DA 20%. Circulation 1986;74:555-563. 8. Alcan KE, Stertzer SH, Wallsh E, DePasquale NP, Bruno MS. The role of intra-aortic balloon counterpulsation in patients undergoing percutaneous translu- minal coronary angioplasty. Am Heart J 1983;105:527-553. 9. Hartzler GO, Rutherford BD, McConahay DR, Johnson WL, Giorgi LV. “High risk” percutaneous transluminal coronary angioplasty. Am J Cardiol 1988;61:33G-376. 10. Vogel RA, Shawl F, Tommaso CL, O’Neill W, Overlie P, O’Toole J, Vandor- mael M, Topol E, Tabari KT, Vogel J, Smith S, Freedman R, White C, George B, Tierstein P. Initial report of the National Registry of elective cardiopulmonary bypass supported coronary angioplasty. J Am Co11 Cardiol 1990;15:23-29.

Prognosis of Congestive Heart Failure in Elderly Patients with Normal Versus Abnormal Left Ventricular Systolic Function Associated with Coronary Artery Disease Wilbert S. Aronow, MD, Chul Ahn, PhD, and ltzhak Kronzon, MD

T he Framingham study demonstrated that the 5-year mortality after the onset of symptoms of congestive

heart failure (CHF) was 62% for men and 42% for wom- en.’ Franciosa et al2 found that the 3-year mortality rate for men with chronic CHF due to coronary artery disease or idiopathic dilated cardiomyopathy was 76%. CHF may occur with normal or abnormal left ventricular (LV) ejection fraction.3-s We report the results from a prospec- tive study of elderly patients with CHF associated with coronary artery disease correlating normal and abnormal LV ejection fraction with cardiac mortality and total mortality.

In a prospective study, CHF was diagnosed in 294 of 1,319 elderly patients (22%) in a long-term health care facility. CHF was diagnosed if2 criteria were satis3ed: (1) Pulmonary basilar rales were heard by 2 physicians including the senior author; and (2) pulmonary vascular congestion waspresent on the chest roentgenogram inter- preted by both an experienced radiologist and the senior author.

From the Hebrew Hospital for Chronic Sick, 2200 Givan Avenue, Bronx, New York 10475; the Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, and the Department of Medicine, New York University School of Medicine, New York, New York. Manuscript received May 14, 1990; revised manuscript received June 25,1990, and accepted June 26.

M-mode and 2-dimensional echocardiograms and continuous-wave and pulsed-Doppler echocardiograms were recorded as previously described9-” at the time CHF was diagnosed. Technically adequate 2-dimen- sional echocardiograms for measuring LV ejection frac- tion were obtained in 247 of 294 patients (84%). All echocardiograms were interpreted by an experienced echocardiographer (Z.K.). LV volumes at end-diastole and end-systole were calculated by planimetry from the Z-dimensional study. LV ejection fraction was calculat-

--- TABLE I Baseline Characteristics of Patients with Congestive Heart Failure Associated with Coronary Artery Disease and Normal and Abnormal Left Ventricular Ejection Fraction

Normal LV Abnormal LV Ejection Ejection Fraction Fraction

Variable (n = 68) (n = 98) p Value

LV ejection fraction (%) 60 f 6 (51-80) 34 f 9 (12-49) <O.OOi

Age W) 84 f 6 (62-96) 81 i 8 (62-97) <0.05 Gender (female) (%) 53 (78) 63 (64) NS Atrial fibrillation (%) 23 (34) 36 (37) NS Third heart sound (%) 25 (37) 88 (90) <O.cQl Systemic hypertension 36 (53) 58 (59) NS

(%) Follow-up (mos) 23 f 17 (l-58) 16 f 13 (2-53) <O.Ol

LV = left ventricular; NS = mt sgnificant.

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