Results and Complications of Intraaortic Balloon Counterpulsation Charles B. Beckman, M.D. ,Alexander S. Geha, M.D. , Graeme L. Hammond, M.D., and Arthur E. Raue, M.D.
ABSTRACT During the forty-month period ending July, 1976, intraaortic balloon counterpulsation was used as an adjunct to medical or surgical therapy in 273 patients. Thirty-seven developed complications. Limb ischemia occurred in 16; it resolved in 12, resulted in gangrene of the toes in 1 and leg gangrene in 2, and was the cause of death in 1 patient. Aortic dissection was confirmed in 7 patients and strongly suspected in another 4. Eight of the 11 patients with dissection underwent cardiac procedures with heparinization at two days to three months after balloon insertion with no untoward effects. Septicemia developed in 2 patients, 1 of whom died of cardiogenic shock. Localized groin sepsis occurred in 8 patients, 2 of whom required removal of infected Dacron graft material. Awareness of the complications of balloon insertion, proper attention to details of balloon management at the time of insertion and removal, and continuous monitoring through a central-lumen balloon should decrease the incidence of complications.
This report reviews the clinical and hemodynamic response to balloon counterpulsation as well as its complications in a series of patients treated over a three-year period. Clinical indications for counterpulsation that have evolved during this time are elaborated, as are its limitations, and management of the complications encountered is outlined. From the Division of Thoracic and Cardiovascular Surgery, Yale University School of Medicine and the Yale-New Haven Hospital, New Haven, CT. Supported in part by Research Grant No. HL 19182-01from the National Heart, Lung, and Blood Institute, National Institutes of Health. We are grateful to Drs. W. W. L. Glenn, H. C. Stansel, and R. K. Shaw for allowing us to review their patients. Presented at the Thirteenth Annual Meeting of The Society of Thoracic Surgeons, Jan 24-26, 1977, San Francisco, CA. Address reprint requests to Dr. Geha, Department of Surgery, Yale University School of Medicine, 333 Cedar St, New Haven, CT 06510.
550
Clinical Material During the forty-month period ending July, 1976, intraaortic balloon cou nterpulsation (IABC) was used as an adjunct to medical or surgical therapy in 273 patients at Yale-New Haven Hospital. Balloon insertion was attempted in another 15 patients, but it was unsuccessful due to severe aortoiliac atheromatous disease. There were 202 men and 71 women whose ages ranged from 13 to 82 years (average, 53.2 years). The duration of counterpulsation varied from one hour to twenty-seven days (average, 3.1 days). In 45 patients the balloon was used in conjunction with medical therapy alone, and in the remaining 228 patients it was used in combination with cardiac operation. Follow-up data were obtained by direct examination and interview of the patients by their cardiologists and surgeons. The New York Heart Association Functional Classification system was used, and patients were assigned a follow-up class no higher than that permitted by their exercise tolerance.
lndications and Results The indications for insertion of the balloon included cardiogenic shock secondary to myocardial infarction, severe left ventricular failure secondary to acute infarction, acute coronary insufficiency, severe left main coronary artery stenosis, recurrent ventricular tachyarrhythmias, failure to wean from cardiopulmonary bypass, postoperative low cardiac output syndrome, and miscellaneous conditions. CARDIOGENIC SHOCK SECONDARY TO MYOCARDIAL INFARCTION. Forty patients had acute transmural infarction documented by new Q waves and by marked elevation of cardiac enzymes (lactic dehydrogenase, serum glutamic oxaloacetic transaminase, and creatine phosphokinase). The diagnosis of cardiogenic shock
551 Beckman et al: Intraaortic Balloon Counterpulsation
was accepted only when all the following criteria were met: systolic blood pressure below 90 mm Hg; urine output below 20 mllhr; impairment of mental status; cold, cyanotic extremities; and absence of hypovolemia as documented by central venous pressure above 15 cm H,O or pulmonary capillary wedge pressure above 16 mm Hg. All 40 patients were given a trial of catecholamine therapy prior to institution of IABC. Twenty underwent cardiac catheterization; 7 of these had acute ventricular septa1 rupture, 6 had acute mitral regurgitation, and 7 had a large, akinetic infarct. Only 12 of the 40 patients could be weaned from the balloon. Eight (20%) survived and were discharged from the hospital (Tables 1,2); 6 are still alive (1in Class I, 4 in Class 11, and 1in Class 111) and the other 2 died five and eighteen months following discharge. During the study period, 7 similar patients in cardiogenic shock did not have IABC because of inability to introduce the balloon (2 patients) or lack of an avail-
able balloon console (5 patients). All 7 died of myocardial failure. SEVERE LEFT VENTRICULAR FAILURE SECONDARY
Sixteen patients had such severe failure that maximal diuretic therapy was insufficient to relieve dyspnea at rest. All of those patients were in Class IV, but they were not classified as being in shock because they had a systolic blood pressure above 90 mm Hg. Six patients had acute ventricular aneurysm, and 2 had generalized poor contractility. Three of the 16 patients were treated with IABC and medical therapy, with 1survivor (see Table 1).In the remaining 13, IABC was utilized prior to operation. Seven patients survived operation and were discharged from the hospital (Table 3); all are in Class I or 11. During the same study period 10 similar patients underwent operation without preoperative institution of IABC; 4 survived. ACUTE CORONARY INSUFFICIENCY. SeventyTO ACUTE INFARCTION.
Table 1 . Survival (Hospital Discharge) following l A B C with Medical and Surgical Therapy in 273 Patientsa IABC and Medical Therapy Major Indication Cardiogenic shock secondary to MI Severe acute LV failure secondary to MI Acute coronary insufficiency Without recent MI With subendocardial MI With transmural MI Severe left main coronary stenosis (with or without acute MI) Tachyarrhythmias Failure to wean from bypass Postoperative low-output state Miscellaneous Total
No. of Patients
Survivors ("/o)
IABC and Surgical Therapy No. of Patients
Survivors ("/o)
Total IABC No. of Patients
Survivors (%)
29
7 (24)
11
1 (9)
40
8 (20)
3
1(33)
13
7 (54)
16
8 (50)
45 21 4 21
41 (91) 18 (86) 3 (75) 16 (76)
45 21 7 22
41 (91) 18 (86) 5 (71) 16 (73)
...
0 0 3
... 2 (67) 0
1
2 0
0
8 47
3 (38) 19 (40)
10 47
3 (30) 19 (40)
0
...
33
10 (30)
33
10 (30)
7
4 (57)
25
22 (88)
32
26 (81)
45
14 (31)
228
140 (61)
273
154 (56)
aPatients subdivided according to major indication for counterpulsation.
MI = myocardial infarction; LV = left ventricular.
552 The Annals of Thoracic Surgery Vol 24 No 6 December 1977
Table 2 . Survival (Hospital Discharge) following lABC with Medical and Surgical Therapy in 40 Patients with Cardiogenic Shock Secondary to Myocardial Infarction IABC and Medical
IABC and Surgical
Therapy
Therapy
Major Hemodynamic Abnormality
Patients
(YO)
Ventricular septal rupture Mitral regurgitation Aneurysmal infarct Severe akinesia
3 2 2 22
0 0 0 7a (32)
4 4 2 1
29
7 (24)
11
Total
No. of
Survivors
No. of
Patients
Total IABC
(YO)
Survivors
No. of Patients
Survivors
0 0 0 lb(100)
7 6 4 23
0 0 0 8 (35)
1 (9)
40
8 (20)
( O/O)
"One late death occurred 18 months after discharge; sudden, presumably due to myocardial ischemia. late death occurred 5 months after discharge due to cardiac failure.
Table 3 . Survival following lABC and Surgical Therapy in 13 Patients with Intractable Left Ventricular Failurea ~~
Major Hemodynamic
Abnormalihr
Ventricular septal rupture Mitral regurgitation Left ventricular aneurysm Severe akinesia Total
No. of No. of Patients Survivors
4 4 3 2 13
3 1 1 2 7 (54%)
aPatientssubdivided according to their major hemodynamic abnormality.
three patients received IABC because of acute coronary insufficiency with recurrent prolonged (> 20 min) attacks of rest angina despite maximal therapy with propranolol and long-acting nitrates. These attacks were characteristically unrelieved by nitroglycerin, and they were accompanied by electrocardiographic changes of S-T and T segment elevation or depression (>1 mm) or ventricular arrhythmias. Patients with acute coronary insufficiency who responded to aggressive medical therapy, including large doses of propranolol, were managed without IABC, thus reserving counterpulsation for the most severely ill patients. Of the 73 patients in this group, 45 had no evidence of acute myocardial infarction, whereas 21 had enzyme elevations consistent with subendocardial infarction
and 7 had electrocardiographic changes of transmural infarction. Following IABC, 52 of the 73 patients became angina free and another 17 were greatly improved. The 45 patients who did not have acute infarction underwent coronary revascularization, with 4 deaths (8.9%). The 21 patients with subendocardial infarction underwent revascularization, with 3 deaths (14.3%). The survivors are in Class I (51 patients) or I1 (8 patients). IABC was used alone in 3 patients who had acute coronary insufficiency and threatened extension of a transmural infarct, with 1 death, and it was used in conjunction with revascularization in 4 similar patients, also with 1 death (see Table 1). SEVERE LEFT M A I N C O R O N A R Y ARTERY STE-
IABC was used prophylactically before operation in 21 patients who had left main coronary artery narrowing of at least 90% (see Table 1). Eight patients had the balloon inserted prior to catheterization because of refractory acute coronary insufficiency, but they are classified here in view of the location of the obstructive coronary lesion. The remaining patients, all with Class I11 or IV angina, had the balloon inserted preoperatively but after catheterization. The operative mortality was 23.8% (5 of the 21 patients). It was especially high (50%) among the 8 patients who had coexistent acute coronary insufficiency, while the 13 without acute coronary insufficiency had an operative mortality of 7.7% (1patient). NOSIS.
553 Beckman et al: Intraaortic Balloon Counterpulsation
During this period 4 patients who had left main coronary artery stenosis and acute coronary insufficiency did not receive balloon support. All died (1during cardiac catheterization, 2 while being weaned from large doses of propranolol prior to operation, and 1during operation). An additional patient received IABC but developed a large infarction prior to contemplated operation and did not undergo the surgical procedure. RECURRENT
VENTRICULAR
were being weaned rapidly from large doses of propranolol; patients with combined diffuse coronary disease and valve involvement in whom a long, difficult procedure was anticipated; and patients with acute coronary insufficiency syndrome in whom angiography did not demonstrate major coronary disease. Seven of the 32 patients were treated medically, and 4 (57%) survived; 22 (88%) of the 25 who underwent operation lived.
TACHYARRHYTH-
MIAS. Ten patients had recurrent tachycardia Balloon Management or fibrillation following acute myocardial infarc- Except for balloon insertions done when we tion despite medical management with combi- were trying to bring patients off bypass, all innations of lidocaine, procainamide, quinidine, sertions were performed in the surgical intenand propranolol. IABC effectively stabilized the sive care unit, as were all balloon removals. arrhythmia in 7 patients. Two patients died after Fluoroscopy was not used, but balloon position the balloon was removed when the nonopera- was checked by portable chest roentgenogram tive approach was used. Of the 8 who had IABC before the sterile drapes were removed. In 2 followed by operation (revascularization in 3 instances of difficult insertion, the opposite and infarctectomy in 5), 3 patients (37.5%) groin was successfully used; and in 4 patients in were discharged alive, and they are in Class 11. whom femoral insertion at the time of cardiac FAILURE TO WEAN FROM CARDIOPULMONARY operation was impossible, the aortic arch was BYPASS. IABC was instituted in 47 patients used successfully. who could not maintain a systolic blood presThe AVCO* balloon was utilized in all patients. sure above 90 mm Hg off cardiopulmonary Whenever possible, a 40 cc balloon was inserted. bypass despite left atrial filling pressures greater All patients received heparin intravenously, than 24 mm Hg and simultaneous use of 5,000 units every 4 to 8 hours, except in the catecholamines. These patients also frequently immediate postoperative period. Dextran was manifested tachyarrhythmias. A satisfactory not used. Cephalosporin antibiotics were given hemodynamic state was achieved in 34 (72.3%); prophylactically throughout the period of IABC. 23 (48.9%) were then successfully weaned from All femoral balloons were threaded through a 10 the balloon, and 19 (40.4%) survived to be dis- mm woven Dacron graft sutured end-to-side to a charged from the hospital, 15 in Class I, 3 in longitudinal arteriotomy. Upon removal, a Class 11, and 1in Class 111. Fogarty catheter was passed in both directions POSTOPERATIVE LOW CARDIAC OUTPUT SYNthrough the arteriotomy; the Dacron graft diverDROME. Thirty-three patients were treated with ticulum was then oversewn in the form of a IABC when, after successful weaning from patch angioplasty after any loose pseudointima bypass, they subsequently deteriorated hemo- was removed. Before closure, the wound was dynamically and exhibited all the classic signs of irrigated with bacitracin solution. cardiogenic shock. Fifteen (45.4%)were eventually weaned from the balloon, and 10 (30.3%) were discharged alive, 8 in Class I and 2 in Complications of IABC Thirty-seven of the 273 patients (13.5%) deClass 11. MISCELLANEOUS INDICATIONS. Thirty-two veloped complications from the balloon. Limb patients could not be classified into any of the ischemia occurred in 16 (5.9%), whose mean previous categories. They included patients average duration of IABC was 4.8 days comwho had poor left ventricular function prior to pared with 3.1 days for the entire group ( p < operation (ejection fraction < 0.2); preoperative patients with extensive coronary disease who *Hoffman-LaRoche, Inc, Cranbury, NJ 08512.
554 The Annals of Thoracic Surgery Vol 24 No 6 December 1977
0.02). The ischemia was in the contralateral limb in 1patient and the ipsilateral limb in the other 15; it resolved completely with thrombectomy or balloon removal (or both) in 10. In 2 patients, whose initial symptoms had been overlooked, mild residual claudication resulted. More important, the ischemic changes progressed in 4 patients to loss of toes in 1, below-knee amputation in 2, and death in 1. This last patient had severe aortoiliac disease, and after the balloon was inserted almost no proximal flow was observed. She immediately developed a cold, anesthetic leg, necessitating transfer of the balloon to the opposite groin. Bilateral leg ischemia then developed, which required angiography to define the problem. A translumbar aortogram was accompanied by technical difficulties leading to retroperitoneal hemorrhage and shock, with subsequent myocardial infarction and death two days later. Aortic dissection occurred in 11patients (4'/0), all of whom had had somewhat difficult balloon Fig 1 . Plain chest roentgenogram (left) and aortogram (right)showing extraluminal intramural location of an intraaortic balloon in a patient w i t h unstable angina whose aortic dissection was not recognized until catheterization. The balloon was immediately removed, and the patient underwent coronary bypass successfully seuen days later. Balloon function was normal despite the dissection.
insertions. The dissection was confirmed in 7 either as an incidental angiographic finding (Fig l), at postmortem examination, or from direct inspection of the femoral artery during reexploration of the groin. The 4 other patients, in whom dissection was strongly suspected, developed back pain following insertion together with a fall in hematocrit or enlargement of the mediastinum. Back and abdominal pain was the most frequent symptom in patients with proved dissection. In 3 patients the dissection was recognized before counterpulsation was initiated, and the balloon was removed without residual difficulty. None of the remaining 8 patients who underwent IABC prior to recognition of dissection suffered any major problem related to the dissection. Eight of these 11patients were operated on with heparinization two days to three months following balloon insertion with no untoward effect. Balloon-related infections occurred in 10 patients (3.7%), whose average duration of IABC was 5.5 days. Two developed septicemia; 1died of cardiogenic shock after twenty-seven days of counterpulsation, and the other responded to change in antibiotics and balloon removal. Localized wound sepsis occurred in 8 patients, 2 of whom required subsequent removal of infected Dacron graft material.
555 Beckman et al: Intraaortic Balloon Counterpulsation
We encountered no instances of gas embolism and symptomatic stability. This allows maneufrom the balloon or the leg neuropathies, com- verability in the operative schedule and permits plications which have been reported by other operation on an urgent rather than emergency authors [l, 19, 291. One patient who had been basis. The results in the three categories of acute complaining of abdominal pain prior to balloon coronary insufficiency (see Table 1) stress the insertion developed cecal perforation during wisdom of proceeding with early catheterization balloon counterpulsation, possibly a related and operation before myocardial damage supercomplication [261. He underwent colonic resec- venes, as the mortality was substantially intion and subsequent coronary revascularization creased by infarction even in the absence of elecand had a good functional recovery. trocardiographic changes of transmural damage [lo, 121. Comment The relatively high operative mortality among With increasing experience, the original indica- patients with severe left main coronary artery tions for IABC in cardiogenic shock due to acute stenosis may reflect our evolving experience in infarction, postoperative severe low-output the operative approach to patients with this lestate, or inability to wean from cardiopulmonary sion. It had been our practice to reflect the heart bypass 17-9, 11, 20, 23, 26, 28, 301 have been out of the pericardium in order to measure the extended to include refractory unstable angina grafts before instituting cardiopulmonary [13, 15, 181, recurrent life-threatening tachyar- bypass. This occasionally resulted in sudden rhythmias [17, 241, and preoperative support in hemodynamic deterioration and operative the presence of severe left ventricular dysfunc- death. More recently we have avoided such mation [6,16]. Although the initial clinical response neuvers, and in our last 30 patients there have to IABC is almost always excellent, the end- been only 2 deaths. As might be anticipated from a procedure inresult depends upon the severity of cardiac disease and what can be accomplished surgically. volving the introduction of a large foreign body In cardiogenic shock, long-term survival re- through major vessels, IABC is associated with mained low despite IABC, with an overall mor- a number of complications including thromtality of 80%; in this series the better results boembolism, vascular problems, dissection, achieved with IABC and medical therapy com- and localized or systemic infection [l, 3, 4, 22, pared with those of IABC and operation reflect a 25, 261. Most ischemic problems developed conservative surgical approach to this entity. when balloon insertion was difficult. ComplicaOperation was performed only in patients who tions occurred in the limb into which the balloon did not respond to IABC and who continued to was inserted in 15 of the 16 cases, stressing the deteriorate, with progressive acidosis, falling necessity to check for peripheral pulses after balurine output, deteriorating blood gas levels, and loon insertion and to observe the lower exincreasing need for vasopressors. On the other tremities continuously. When limb ischemia hand, patients who had severe left ventricular develops, serious consideration must be given dysfunction and acute failure secondary to re- to removal of the balloon or to immediate cardiac cent infarction and who did not have the full- operation with placement of the balloon in the blown picture of cardiogenic shock showed a aortic arch if necessary. Early thrombectomy better response to IABC, and when operation was associated with recovery of limb viability was associated with IABC, these patients had a and function in the majority of these patients. better survival rate. The overall mortality of 50% The use of heparin at regular intervals after balin this small group is in the same range as that loon insertion may also have contributed to our reported by others [2, 91, and the functional re- relatively low incidence of thrombosis [l, 26, sults have been very gratifying. 291. Additionally, careful removal of any Our experience with IABC in acute coronary pseudointima lining the graft diverticulum at insufficiency indicates that it does not appreci- the time of balloon withdrawal should reduce ably lower operative mortality [5,14,18,21,27]. thromboembolic complications by preventing its However, IABC provides electrocardiographic later dislodgment and embolization.
556 The Annals of Thoracic Surgery Vol 24 No 6
December 1977
Our relatively good outcome with aortic dissection may be fortuitous, as there have been several reports of death subsequent to aortic perforation or dissection from the balloon 119, 261. Accordingly, dissection should be regarded as a very serious complication; whenever it is recognized, the balloon should be removed immediately and cardiac operation delayed for at least two weeks if possible. Additionally arterial perfusion at the time of cardiopulmonary bypass should be performed through the ascending aorta in order to decrease the likelihood of a retrograde dissection, which may extend with femoral artery perfusion. We have observed excellent diastolic augmentation despite subintima1 location of the balloon in the dissected aortic wall; thus, this complication does not preclude proper function of the balloon. Aortography may be required to confirm or rule out dissection. One should desist from attempting to introduce the balloon when strong resistance is encountered (Fig 2). We have recently been Fig 2 . Roentgenogram of the abdomen showing an evaluating the use of a central-lumen balloon intraaortic balloon kinked in the abdominal aorta that can be passed over a guide wire under following an insertion that met with resistance due to atheromatous disease in the aorta. Fluoroscopic fluoroscopic control and through which con- and pressure monitoring through a centrul lumen tinuous monitoring of arterial pressure and in- kelps to avoid these difficulties of balloon insertion. jection of contrast material can be performed Our experience underlines the importance [31]. Such a balloon has allowed us to provide counterpulsation to several patients with severe of IABC for temporary support of patients aortoiliac atheromatous disease in whom dissec- acutely ill with cardiac disease. Stabilization of the hemodynamic state allows time for diagnostion would have been a distinct possibility. Systemic infection is extremely serious and tic procedures and selection of the appropriate calls for immediate removal of the balloon. A therapeutic course. In patients with poor carlocalized wound infection often can be con- diovascular function following a cardiac operatrolled with debridement and local wound care, tion, IABC reduces the requirement for but 2 of the 8 patients who had this complication catecholamines and the ensuing tachyarrequired arterial reconstruction after removal of rhythmias and other side-effects. It also increases the salvage rate among these patients by infected Dacron material. Abdominal pain following balloon insertion interrupting the vicious cycle of progressively is relatively common. If this symptom occurs, deteriorating myocardial function. Awareness the patient should be observed very carefully of the complications of balloon insertion should with particular attention to bowel sounds, ab- help to decrease their incidence. dominal rigidity, and leukocytosis. In our entire series we have observed 1instance of gangrene References of the cecum with perforation; fortunately, early 1. Alpert J, Bhaktan EK, Gielchinsky I, et al: Vascular complications of intra-aortic balloon pumprecognition and immediate right colectomy reing. Arch Surg 111:1190,1976 sulted in the patient’s survival. Two deaths due 2. Baron DW, O’Rourke MF: Long-term results of to gangrenous bowel were reported by Pace and arterial counterpulsation in acute severe cardiac associates [26] in their series of 104 patients refailure complicating myocardial infarction. Br Heart J 38:285, 1976 ceiving IABC.
557 Beckman et al: IntraaorticBalloon Counterpulsation
3. Barsamian EM, Goldman M, Crane C, et al: Femorofemoral bypass graft in intra-aortic balloon counterpulsation. Arch Surg 111:1070, 1976 4. Bernstein EF, Murphy AE: The importance of pulsation in preventing thrombosis from intra-aortic balloons. J Thorac Cardiovasc Surg 62:950, 1971 5. Bertolasi CA, Troge JE, Carreno CA, et al: Unstable angina-prospective and randomized study of its evolution, with and without surgery: preliminary report. Am J Cardiol 33:201, 1974 6. Bolooki H, Williams W, Thurer R, et al: Clinical and hemodynamic criteria for use of the intraaortic balloon pump in patients requiring cardiac surgery. J Thorac Cardiovasc Surg 72:756, 1976 7. Buckley MJ, Craver JM, Gold HK, et al: Intraaortic balloon pump assist for cardiogenic shock after cardiopulmonary bypass (abstract). Circulation 46:Suppl 2:76, 1972 8. Buckley MJ, Craver JM, Gold HK, et al: Intraaortic balloon pump assist for cardiogenic shock after cardiopulmonary bypass. Circulation 48:Suppl 3:90, 1973 9. Buckley MJ, Mundth ED, Daggett WM, et al: Surgical management of ventricular septa1 defects and mitral regurgitation complicating acute myocardial infarction. Ann Thorac Surg 16:598, 1974 10. Conti CR, Brawley RK, Griffith LSC, et al: Unstable angina pectoris: morbidity and mortality in 57 consecutive patients evaluated angiographically. Am J Cardiol 32:745, 1973 11. Dunkman WB, Leinbach RC, Buckley MJ, et al: Clinical and hemodynamic results of intra-aortic balloon pumping and surgery for cardiogenic shock. Circulation 46:465, 1972 12. Gazes PC, Mobley EM, Faris HM, et al: Preinfarctional (unstable) angina: a prospective study: ten years follow-up: prognostic significance of electrocardiographic changes. Circulation 48:331, 1973 13. Geha AS: The role of coronary artery bypass surgery in the management of ischemic heart disease. Conn Med 40:530, 1976 14. Geha AS, Baue AE, Krone RJ, et al: Surgical treatment of unstable angina by saphenous vein and internal mammary artery bypass grafting. J Thorac Cardiovasc Surg 71:348, 1976 15. Gold HK, Leinbach RC, Buckley MJ, et al: Refractory angina pectoris, follow-up after intra-aortic balloon pumping and surgery. Circulation 54:Suppl 3:41, 1976 16. Goldman BS, Walker P, Gunstensen J, et al: Intra-aortic balloon pump assist: Adjunct to surgery for left ventricular dysfunction. Can J Surg 19:128, 1976 17. Graham AF, Miller DC, Stinson EB, et al: Surgical treatment of refractory life-threatening ventricular tachycardia. Am J Cardiol32:909, 1973 18. Hammond GL, Poirier RA: Surgical management for acute coronary insufficiency with three years’ follow-up. J Thorac Cardiovasc Surg 69:625, 1975
19. Kaiser GC, DiMarco J, Barer HB, et al: Intra-aortic balloon assistance. Ann Thorac Surg 21:487,1976 20. Krakauer JS, Rosenbaum A, Freed PS, et al: Clinical management ancillary to phase-shift balloon pumping in cardiogenic shock. Am J Cardiol 27:123, 1971 21. Miller DC, Cannom DS, Fogarty TJ, et al: Saphenous vein coronary artery bypass in patients with ”preinfarction angina.” Circulation 47:234, 1972 22. Moore EE, Broecker B, DeMeules JE, et al: Removal of intraaortic balloon without vascular complications. Ann Thorac Surg 21:566, 1976 23. Mundth ED: Mechanical and surgical interventions for the reduction of myocardial ischemia. Circulation 53:Suppl 1:176, 1976 24. Mundth ED, Buckley MJ, DeSanctis RW, et al: Surgical treatment of ventricular irritability. J Thorac Cardiovasc Surg 66:943, 1973 25. Ortiz AF, Lukban SB, Jurado RA, et al: The use of vein allografts as sidearms for intraaortic balloon insertion. Ann Thorac Surg 19:574, 1975 26. Pace P, Tilney N, Couch N, et al: Peripheral arterial complications of intra-aortic balloon counterpulsation. Circulation 54:Suppl 2:13, 1976 27. Scanlon PJ, Nemickas R, Moran JF, et al: Accelerated angina pectoris: clinical, hemodynamic, arteriographic and therapeutic experience in 83 patients. Circulation 47:19, 1973 28. Scanlon PJ, O’Connell J, Johnson SA, et al: Balloon counterpulsation following surgery for ischemic heart disease. Circulation 54:Suppl 3:90, 1976 29. Scheidt S, Wilner G, Mueller H, et al: Intra-aortic balloon counterpulsation in cardiogenic shock: report of a cooperative trial. N Engl J Med 288:979, 1973 30. Stewart S, Biddle T, DeWeese J: Support of the myocardium with intra-aortic balloon counterpulsation following cardiopulmonary bypass. J Thorac Cardiovasc Surg 72:109, 1976 31. Wolfson S, Geha AS, Hammond GL, et al: Preliminary report: modification of intra-aortic balloon for pressure measurement, contrast injection and guide wire passage. Am J Cardio139:260,1977
Discussion
DR. JOHN c. M C CABE (New York, NY): Dr. Beckman’s experience is similar to ours at Cornell and to that of other published series. There is little doubt that IABC is effective in relieving refractory ischemia, as demonstrated by the excellent results in the group with acute coronary insufficiency. The major advantage here is the ability to convert an unstable state to a controlled situation in which patients can be studied and operated on semielectively and safely. Cardiogenic shock after myocardial infarction remains the primary indication for use of counterpulsation. In contrast to the New Haven series, our experience has been that survival is rare in the group treated with medical therapy and IABP alone. For that reason
558 The Annals of Thoracic Surgery Vol 24 No 6 December 1977
we recommend studying these patients as soon as they can be stabilized on counterpulsation. Of the operable patients in this group-those who have mechanical defects or bypassable coronary lesions-we have salvaged 40% with emergency operations. In an attempt to evaluate the problem of complications with IABC, we recently reviewed 100 consecutive cases of attempted balloon insertion. Inserting the balloon was difficult because of aortoiliac atherosclerosis in 27% of the patients, and it proved impossible by the groin approach in 21%. Three patients subsequently had the balloon inserted through the ascending aorta. Although this problem is related to the diffuse nature of atherosclerosis, it also correlates with age, in that the average age of the group who had successful insertion was 57 years compared with 64 years in the group in whom insertion could not be done. We saw a higher incidence of complications in this group of 100 patients: 23% developed complications compared with 13% in the Yale series. If those patients who did not survive to have the balloon removed were excluded, this figure would be higher. As in the present series, dissection (7 patients) and ischemic extremity (10 patients) were most commonly seen. Four of the dissections were unsuspected and were found at catheterization or postmortem examination. In each instance, the patient was successfully counterpulsed despite the balloon being positioned in a false lumen. Most dissections occurred in the group with cardiogenic shock, in whom there is a tendency to push harder to accomplish balloon positioning. No patients died from the complication of dissection in our series. However, there were 2 deaths related to balloon pumping: 1was from perforation of the common iliac artery and the second from infection of an ascending aortic balloon Dacron graft conduit and eventual hemorrhage at the suture line after graft removal. I don’t think this complication has been reported. These complications must necessarily be weighed against the lesser indications for IABC, particularly its prophylactic use in patients with left main coronary artery occlusion without refractory ischemia and in those with compromised left ventricular function. I would like to ask Dr. Beckman if he includes weaning from propranolol as one of the indications for IABC. We no longer try to discontinue propranolol in ischemic patients; therefore, we don’t believe this should be included as an indication for the use of IABC . D R . w . GERALD RAINER (Denver, CO): Dr. Beckman’s results are extremely good considering the classification of patients in the study. I was most impressed with his salvage of patients in whom dissection had occurred. We have not been so fortunate. Our indications for pumping are a bit more rigid, and we have
had 4 dissections in a series of 50 consecutive patients undergoing IABC. We have not saved any of these 4 patients, and it may be that we were not aggressive enough in identifying the problem early and in removing the balloon. We also were impressed by the fact that the balloon functioned well in spite of its extraluminal location. In 2 additional patients we had a complication that really relates to material and durability-a split in the balloon catheter corresponding to its location at about the aortoiliac position, probably caused by pulsation against an extremely rigid atheromatous plaque. I would like to ask Dr. Beckman if he could elaborate further on the use of an open-lumen balloon to facilitate passage in difficult patients. DR. WILLARD M . DAGGETT (Boston, MA): Dr. Beckman and his co-workers have carefully enumerated the types of problems one can encounter in the course of using the balloon pump. An observation that stands out in my mind, however, is the infrequency of complications with the device, especially considering the incidence of peripheral arterial disease in patients who require this type of assistance. There is one area of management in which I would like to register a differing opinion, and that concerns the group in cardiogenic shock. If one is going to operate on these patients-and certainly they are a difficult group at best-it must be done early, before all the person’s assets are dissipated. This is particularly true with patients who have mechanical complications such as ventricular septa1 defect or mitral regurgitation. In this setting the balloon will reverse the patient’s hemodynamic slide only temporarily, and to achieve success in this group of patients one must operate while the conditions are right. I would like to ask Dr. Beckman how he is following survivors in the cardiogenic shock group who were treated solely with the balloon. We and others have observed a rather poor outlook in this group in the year after hospital discharge. Are you electively studying and operating on these patients later on, after they have recovered?
(Cincinnati, OH): We have found that postoperative limb ischemia seems to occur more frequently in patients in whom blood flow around the balloon catheter was markedly diminished at the time the balloon was inserted. Dilation of the iliac and femoral arteries leads to brisk flow past the catheter, and we achieve this by positioning the balloon in the pelvic vessels and allowing it to pulsate a few times before advancing it into the thoracic aorta. This maneuver has led to an apparent decrease in the incidence of limb ischemia associated with use of the intraaortic balloon. DR. JOHN B. FLEGE, JR.
DR. BECKMAN: Dr. McCabe and Dr. Daggett have raised a question about the discrepancy between their results and ours with surgical treatment of patients in
559 Beckman et al: Intraaortic Balloon Counterpulsation
cardiogenic shock secondary to acute myocardial infarction. I think Dr. Daggett has outlined well the reason why our surgical approach was less successful. When we coupled IABC with operative intervention in this group of patients, the operation was performed several days after the institution of IABC. This interval was necessary to determine that these patients were balloon dependent, but by then their condition had deteriorated to the point where it jeopardized the ultimate result of the operation. The late outcome in our patients in this group treated with IABC only has not been too disappointing, however. Six of the 8 early survivors are still alive, 2 died of late cardiac failure. The 6 survivors seem to be relatively asymptomatic; most are in Functional Class 11. Dr. Rainer raised the question of deaths resulting from aortic dissection subsequent to introduction of
the balloon. We consider it a stroke of luck not to have had any deaths from this complication of balloon insertion among 11 patients. We have learned, however, that when we feel the balloon advancing against continued resistance, we should desist from further attempts at blind passage. When confronted with this situation outside the operating room, we resort to the central-lumen balloon developed by the Avco Company in conjunction with Dr. Wolfson of our cardiology department. A guide wire is introduced under fluoroscopic control and then is followed by the central-lumen balloon. In fact, when we anticipate difficultiessecondary to aortoiliac occlusive disease in a patient having a rather elective balloon introduction, we would prefer to perform it from the beginning under fluoroscopic control with this luminal balloon.
Notice from the Editor and the Editorial Board The Editor and members of the Editorial Board are grateful for the assistance given in the review of certain manuscripts during the past year by the following persons:
John G . Batsakis, M.D. Ann Arbor, MI
Herbert Maier, M.D. New York, NY
Douglas M. Behrendt, M.D. Ann Arbor, MI
Mark B. Orringer, M.D. Ann Arbor, MI
David A. Blumenstock, M.D. Cooperstown, NY
Toronto, Ont, Canada
F. Griffith Pearson, M.D.
R. Randolph Bradham, M.D. Charleston, SC
John A. Penner, M.D.
Peter J. Cohen, M.D. Ann Arbor, MI
Mark M. Ravitch, M.D.
Arnold G. Coran, M.D.
J. Gordon Scannell, M.D.
Ann Arbor, MI
Boston, MA
Ann Arbor, MI
Pittsburgh, PA
William Fry, M.D.
Arthur B. Simon, M.D.
Dallas, TX
Ann Arbor, MI
Hermes C. Grillo, M.D. Boston, MA
James C. Stanley, M.D. Ann Arbor, MI
Kenneth A. Kooi, M.D. Ann Arbor, MI
Martha R. Westerberg, M.D. Ann Arbor, MI
ABSTRACT During the forty-month period ending July, 1976, intraaortic balloon counterpulsation was used as an adjunct to medical or surgical therapy in 273 patients. Thirty-seven developed complications. Limb ischemia occurred in 16; it resolved in 12, resulted in gangrene of the toes in 1 and leg gangrene in 2, and was the cause of death in 1 patient. Aortic dissection was confirmed in 7 patients and strongly suspected in another 4. Eight of the 11 patients with dissection underwent cardiac procedures with heparinization at two days to three months after balloon insertion with no untoward effects. Septicemia developed in 2 patients, 1 of whom died of cardiogenic shock. Localized groin sepsis occurred in 8 patients, 2 of whom required removal of infected Dacron graft material. Awareness of the complications of balloon insertion, proper attention to details of balloon management at the time of insertion and removal, and continuous monitoring through a central-lumen balloon should decrease the incidence of complications.
This report reviews the clinical and hemodynamic response to balloon counterpulsation as well as its complications in a series of patients treated over a three-year period. Clinical indications for counterpulsation that have evolved during this time are elaborated, as are its limitations, and management of the complications encountered is outlined. From the Division of Thoracic and Cardiovascular Surgery, Yale University School of Medicine and the Yale-New Haven Hospital, New Haven, CT. Supported in part by Research Grant No. HL 19182-01from the National Heart, Lung, and Blood Institute, National Institutes of Health. We are grateful to Drs. W. W. L. Glenn, H. C. Stansel, and R. K. Shaw for allowing us to review their patients. Presented at the Thirteenth Annual Meeting of The Society of Thoracic Surgeons, Jan 24-26, 1977, San Francisco, CA. Address reprint requests to Dr. Geha, Department of Surgery, Yale University School of Medicine, 333 Cedar St, New Haven, CT 06510.
550
Clinical Material During the forty-month period ending July, 1976, intraaortic balloon cou nterpulsation (IABC) was used as an adjunct to medical or surgical therapy in 273 patients at Yale-New Haven Hospital. Balloon insertion was attempted in another 15 patients, but it was unsuccessful due to severe aortoiliac atheromatous disease. There were 202 men and 71 women whose ages ranged from 13 to 82 years (average, 53.2 years). The duration of counterpulsation varied from one hour to twenty-seven days (average, 3.1 days). In 45 patients the balloon was used in conjunction with medical therapy alone, and in the remaining 228 patients it was used in combination with cardiac operation. Follow-up data were obtained by direct examination and interview of the patients by their cardiologists and surgeons. The New York Heart Association Functional Classification system was used, and patients were assigned a follow-up class no higher than that permitted by their exercise tolerance.
lndications and Results The indications for insertion of the balloon included cardiogenic shock secondary to myocardial infarction, severe left ventricular failure secondary to acute infarction, acute coronary insufficiency, severe left main coronary artery stenosis, recurrent ventricular tachyarrhythmias, failure to wean from cardiopulmonary bypass, postoperative low cardiac output syndrome, and miscellaneous conditions. CARDIOGENIC SHOCK SECONDARY TO MYOCARDIAL INFARCTION. Forty patients had acute transmural infarction documented by new Q waves and by marked elevation of cardiac enzymes (lactic dehydrogenase, serum glutamic oxaloacetic transaminase, and creatine phosphokinase). The diagnosis of cardiogenic shock
551 Beckman et al: Intraaortic Balloon Counterpulsation
was accepted only when all the following criteria were met: systolic blood pressure below 90 mm Hg; urine output below 20 mllhr; impairment of mental status; cold, cyanotic extremities; and absence of hypovolemia as documented by central venous pressure above 15 cm H,O or pulmonary capillary wedge pressure above 16 mm Hg. All 40 patients were given a trial of catecholamine therapy prior to institution of IABC. Twenty underwent cardiac catheterization; 7 of these had acute ventricular septa1 rupture, 6 had acute mitral regurgitation, and 7 had a large, akinetic infarct. Only 12 of the 40 patients could be weaned from the balloon. Eight (20%) survived and were discharged from the hospital (Tables 1,2); 6 are still alive (1in Class I, 4 in Class 11, and 1in Class 111) and the other 2 died five and eighteen months following discharge. During the study period, 7 similar patients in cardiogenic shock did not have IABC because of inability to introduce the balloon (2 patients) or lack of an avail-
able balloon console (5 patients). All 7 died of myocardial failure. SEVERE LEFT VENTRICULAR FAILURE SECONDARY
Sixteen patients had such severe failure that maximal diuretic therapy was insufficient to relieve dyspnea at rest. All of those patients were in Class IV, but they were not classified as being in shock because they had a systolic blood pressure above 90 mm Hg. Six patients had acute ventricular aneurysm, and 2 had generalized poor contractility. Three of the 16 patients were treated with IABC and medical therapy, with 1survivor (see Table 1).In the remaining 13, IABC was utilized prior to operation. Seven patients survived operation and were discharged from the hospital (Table 3); all are in Class I or 11. During the same study period 10 similar patients underwent operation without preoperative institution of IABC; 4 survived. ACUTE CORONARY INSUFFICIENCY. SeventyTO ACUTE INFARCTION.
Table 1 . Survival (Hospital Discharge) following l A B C with Medical and Surgical Therapy in 273 Patientsa IABC and Medical Therapy Major Indication Cardiogenic shock secondary to MI Severe acute LV failure secondary to MI Acute coronary insufficiency Without recent MI With subendocardial MI With transmural MI Severe left main coronary stenosis (with or without acute MI) Tachyarrhythmias Failure to wean from bypass Postoperative low-output state Miscellaneous Total
No. of Patients
Survivors ("/o)
IABC and Surgical Therapy No. of Patients
Survivors ("/o)
Total IABC No. of Patients
Survivors (%)
29
7 (24)
11
1 (9)
40
8 (20)
3
1(33)
13
7 (54)
16
8 (50)
45 21 4 21
41 (91) 18 (86) 3 (75) 16 (76)
45 21 7 22
41 (91) 18 (86) 5 (71) 16 (73)
...
0 0 3
... 2 (67) 0
1
2 0
0
8 47
3 (38) 19 (40)
10 47
3 (30) 19 (40)
0
...
33
10 (30)
33
10 (30)
7
4 (57)
25
22 (88)
32
26 (81)
45
14 (31)
228
140 (61)
273
154 (56)
aPatients subdivided according to major indication for counterpulsation.
MI = myocardial infarction; LV = left ventricular.
552 The Annals of Thoracic Surgery Vol 24 No 6 December 1977
Table 2 . Survival (Hospital Discharge) following lABC with Medical and Surgical Therapy in 40 Patients with Cardiogenic Shock Secondary to Myocardial Infarction IABC and Medical
IABC and Surgical
Therapy
Therapy
Major Hemodynamic Abnormality
Patients
(YO)
Ventricular septal rupture Mitral regurgitation Aneurysmal infarct Severe akinesia
3 2 2 22
0 0 0 7a (32)
4 4 2 1
29
7 (24)
11
Total
No. of
Survivors
No. of
Patients
Total IABC
(YO)
Survivors
No. of Patients
Survivors
0 0 0 lb(100)
7 6 4 23
0 0 0 8 (35)
1 (9)
40
8 (20)
( O/O)
"One late death occurred 18 months after discharge; sudden, presumably due to myocardial ischemia. late death occurred 5 months after discharge due to cardiac failure.
Table 3 . Survival following lABC and Surgical Therapy in 13 Patients with Intractable Left Ventricular Failurea ~~
Major Hemodynamic
Abnormalihr
Ventricular septal rupture Mitral regurgitation Left ventricular aneurysm Severe akinesia Total
No. of No. of Patients Survivors
4 4 3 2 13
3 1 1 2 7 (54%)
aPatientssubdivided according to their major hemodynamic abnormality.
three patients received IABC because of acute coronary insufficiency with recurrent prolonged (> 20 min) attacks of rest angina despite maximal therapy with propranolol and long-acting nitrates. These attacks were characteristically unrelieved by nitroglycerin, and they were accompanied by electrocardiographic changes of S-T and T segment elevation or depression (>1 mm) or ventricular arrhythmias. Patients with acute coronary insufficiency who responded to aggressive medical therapy, including large doses of propranolol, were managed without IABC, thus reserving counterpulsation for the most severely ill patients. Of the 73 patients in this group, 45 had no evidence of acute myocardial infarction, whereas 21 had enzyme elevations consistent with subendocardial infarction
and 7 had electrocardiographic changes of transmural infarction. Following IABC, 52 of the 73 patients became angina free and another 17 were greatly improved. The 45 patients who did not have acute infarction underwent coronary revascularization, with 4 deaths (8.9%). The 21 patients with subendocardial infarction underwent revascularization, with 3 deaths (14.3%). The survivors are in Class I (51 patients) or I1 (8 patients). IABC was used alone in 3 patients who had acute coronary insufficiency and threatened extension of a transmural infarct, with 1 death, and it was used in conjunction with revascularization in 4 similar patients, also with 1 death (see Table 1). SEVERE LEFT M A I N C O R O N A R Y ARTERY STE-
IABC was used prophylactically before operation in 21 patients who had left main coronary artery narrowing of at least 90% (see Table 1). Eight patients had the balloon inserted prior to catheterization because of refractory acute coronary insufficiency, but they are classified here in view of the location of the obstructive coronary lesion. The remaining patients, all with Class I11 or IV angina, had the balloon inserted preoperatively but after catheterization. The operative mortality was 23.8% (5 of the 21 patients). It was especially high (50%) among the 8 patients who had coexistent acute coronary insufficiency, while the 13 without acute coronary insufficiency had an operative mortality of 7.7% (1patient). NOSIS.
553 Beckman et al: Intraaortic Balloon Counterpulsation
During this period 4 patients who had left main coronary artery stenosis and acute coronary insufficiency did not receive balloon support. All died (1during cardiac catheterization, 2 while being weaned from large doses of propranolol prior to operation, and 1during operation). An additional patient received IABC but developed a large infarction prior to contemplated operation and did not undergo the surgical procedure. RECURRENT
VENTRICULAR
were being weaned rapidly from large doses of propranolol; patients with combined diffuse coronary disease and valve involvement in whom a long, difficult procedure was anticipated; and patients with acute coronary insufficiency syndrome in whom angiography did not demonstrate major coronary disease. Seven of the 32 patients were treated medically, and 4 (57%) survived; 22 (88%) of the 25 who underwent operation lived.
TACHYARRHYTH-
MIAS. Ten patients had recurrent tachycardia Balloon Management or fibrillation following acute myocardial infarc- Except for balloon insertions done when we tion despite medical management with combi- were trying to bring patients off bypass, all innations of lidocaine, procainamide, quinidine, sertions were performed in the surgical intenand propranolol. IABC effectively stabilized the sive care unit, as were all balloon removals. arrhythmia in 7 patients. Two patients died after Fluoroscopy was not used, but balloon position the balloon was removed when the nonopera- was checked by portable chest roentgenogram tive approach was used. Of the 8 who had IABC before the sterile drapes were removed. In 2 followed by operation (revascularization in 3 instances of difficult insertion, the opposite and infarctectomy in 5), 3 patients (37.5%) groin was successfully used; and in 4 patients in were discharged alive, and they are in Class 11. whom femoral insertion at the time of cardiac FAILURE TO WEAN FROM CARDIOPULMONARY operation was impossible, the aortic arch was BYPASS. IABC was instituted in 47 patients used successfully. who could not maintain a systolic blood presThe AVCO* balloon was utilized in all patients. sure above 90 mm Hg off cardiopulmonary Whenever possible, a 40 cc balloon was inserted. bypass despite left atrial filling pressures greater All patients received heparin intravenously, than 24 mm Hg and simultaneous use of 5,000 units every 4 to 8 hours, except in the catecholamines. These patients also frequently immediate postoperative period. Dextran was manifested tachyarrhythmias. A satisfactory not used. Cephalosporin antibiotics were given hemodynamic state was achieved in 34 (72.3%); prophylactically throughout the period of IABC. 23 (48.9%) were then successfully weaned from All femoral balloons were threaded through a 10 the balloon, and 19 (40.4%) survived to be dis- mm woven Dacron graft sutured end-to-side to a charged from the hospital, 15 in Class I, 3 in longitudinal arteriotomy. Upon removal, a Class 11, and 1in Class 111. Fogarty catheter was passed in both directions POSTOPERATIVE LOW CARDIAC OUTPUT SYNthrough the arteriotomy; the Dacron graft diverDROME. Thirty-three patients were treated with ticulum was then oversewn in the form of a IABC when, after successful weaning from patch angioplasty after any loose pseudointima bypass, they subsequently deteriorated hemo- was removed. Before closure, the wound was dynamically and exhibited all the classic signs of irrigated with bacitracin solution. cardiogenic shock. Fifteen (45.4%)were eventually weaned from the balloon, and 10 (30.3%) were discharged alive, 8 in Class I and 2 in Complications of IABC Thirty-seven of the 273 patients (13.5%) deClass 11. MISCELLANEOUS INDICATIONS. Thirty-two veloped complications from the balloon. Limb patients could not be classified into any of the ischemia occurred in 16 (5.9%), whose mean previous categories. They included patients average duration of IABC was 4.8 days comwho had poor left ventricular function prior to pared with 3.1 days for the entire group ( p < operation (ejection fraction < 0.2); preoperative patients with extensive coronary disease who *Hoffman-LaRoche, Inc, Cranbury, NJ 08512.
554 The Annals of Thoracic Surgery Vol 24 No 6 December 1977
0.02). The ischemia was in the contralateral limb in 1patient and the ipsilateral limb in the other 15; it resolved completely with thrombectomy or balloon removal (or both) in 10. In 2 patients, whose initial symptoms had been overlooked, mild residual claudication resulted. More important, the ischemic changes progressed in 4 patients to loss of toes in 1, below-knee amputation in 2, and death in 1. This last patient had severe aortoiliac disease, and after the balloon was inserted almost no proximal flow was observed. She immediately developed a cold, anesthetic leg, necessitating transfer of the balloon to the opposite groin. Bilateral leg ischemia then developed, which required angiography to define the problem. A translumbar aortogram was accompanied by technical difficulties leading to retroperitoneal hemorrhage and shock, with subsequent myocardial infarction and death two days later. Aortic dissection occurred in 11patients (4'/0), all of whom had had somewhat difficult balloon Fig 1 . Plain chest roentgenogram (left) and aortogram (right)showing extraluminal intramural location of an intraaortic balloon in a patient w i t h unstable angina whose aortic dissection was not recognized until catheterization. The balloon was immediately removed, and the patient underwent coronary bypass successfully seuen days later. Balloon function was normal despite the dissection.
insertions. The dissection was confirmed in 7 either as an incidental angiographic finding (Fig l), at postmortem examination, or from direct inspection of the femoral artery during reexploration of the groin. The 4 other patients, in whom dissection was strongly suspected, developed back pain following insertion together with a fall in hematocrit or enlargement of the mediastinum. Back and abdominal pain was the most frequent symptom in patients with proved dissection. In 3 patients the dissection was recognized before counterpulsation was initiated, and the balloon was removed without residual difficulty. None of the remaining 8 patients who underwent IABC prior to recognition of dissection suffered any major problem related to the dissection. Eight of these 11patients were operated on with heparinization two days to three months following balloon insertion with no untoward effect. Balloon-related infections occurred in 10 patients (3.7%), whose average duration of IABC was 5.5 days. Two developed septicemia; 1died of cardiogenic shock after twenty-seven days of counterpulsation, and the other responded to change in antibiotics and balloon removal. Localized wound sepsis occurred in 8 patients, 2 of whom required subsequent removal of infected Dacron graft material.
555 Beckman et al: Intraaortic Balloon Counterpulsation
We encountered no instances of gas embolism and symptomatic stability. This allows maneufrom the balloon or the leg neuropathies, com- verability in the operative schedule and permits plications which have been reported by other operation on an urgent rather than emergency authors [l, 19, 291. One patient who had been basis. The results in the three categories of acute complaining of abdominal pain prior to balloon coronary insufficiency (see Table 1) stress the insertion developed cecal perforation during wisdom of proceeding with early catheterization balloon counterpulsation, possibly a related and operation before myocardial damage supercomplication [261. He underwent colonic resec- venes, as the mortality was substantially intion and subsequent coronary revascularization creased by infarction even in the absence of elecand had a good functional recovery. trocardiographic changes of transmural damage [lo, 121. Comment The relatively high operative mortality among With increasing experience, the original indica- patients with severe left main coronary artery tions for IABC in cardiogenic shock due to acute stenosis may reflect our evolving experience in infarction, postoperative severe low-output the operative approach to patients with this lestate, or inability to wean from cardiopulmonary sion. It had been our practice to reflect the heart bypass 17-9, 11, 20, 23, 26, 28, 301 have been out of the pericardium in order to measure the extended to include refractory unstable angina grafts before instituting cardiopulmonary [13, 15, 181, recurrent life-threatening tachyar- bypass. This occasionally resulted in sudden rhythmias [17, 241, and preoperative support in hemodynamic deterioration and operative the presence of severe left ventricular dysfunc- death. More recently we have avoided such mation [6,16]. Although the initial clinical response neuvers, and in our last 30 patients there have to IABC is almost always excellent, the end- been only 2 deaths. As might be anticipated from a procedure inresult depends upon the severity of cardiac disease and what can be accomplished surgically. volving the introduction of a large foreign body In cardiogenic shock, long-term survival re- through major vessels, IABC is associated with mained low despite IABC, with an overall mor- a number of complications including thromtality of 80%; in this series the better results boembolism, vascular problems, dissection, achieved with IABC and medical therapy com- and localized or systemic infection [l, 3, 4, 22, pared with those of IABC and operation reflect a 25, 261. Most ischemic problems developed conservative surgical approach to this entity. when balloon insertion was difficult. ComplicaOperation was performed only in patients who tions occurred in the limb into which the balloon did not respond to IABC and who continued to was inserted in 15 of the 16 cases, stressing the deteriorate, with progressive acidosis, falling necessity to check for peripheral pulses after balurine output, deteriorating blood gas levels, and loon insertion and to observe the lower exincreasing need for vasopressors. On the other tremities continuously. When limb ischemia hand, patients who had severe left ventricular develops, serious consideration must be given dysfunction and acute failure secondary to re- to removal of the balloon or to immediate cardiac cent infarction and who did not have the full- operation with placement of the balloon in the blown picture of cardiogenic shock showed a aortic arch if necessary. Early thrombectomy better response to IABC, and when operation was associated with recovery of limb viability was associated with IABC, these patients had a and function in the majority of these patients. better survival rate. The overall mortality of 50% The use of heparin at regular intervals after balin this small group is in the same range as that loon insertion may also have contributed to our reported by others [2, 91, and the functional re- relatively low incidence of thrombosis [l, 26, sults have been very gratifying. 291. Additionally, careful removal of any Our experience with IABC in acute coronary pseudointima lining the graft diverticulum at insufficiency indicates that it does not appreci- the time of balloon withdrawal should reduce ably lower operative mortality [5,14,18,21,27]. thromboembolic complications by preventing its However, IABC provides electrocardiographic later dislodgment and embolization.
556 The Annals of Thoracic Surgery Vol 24 No 6
December 1977
Our relatively good outcome with aortic dissection may be fortuitous, as there have been several reports of death subsequent to aortic perforation or dissection from the balloon 119, 261. Accordingly, dissection should be regarded as a very serious complication; whenever it is recognized, the balloon should be removed immediately and cardiac operation delayed for at least two weeks if possible. Additionally arterial perfusion at the time of cardiopulmonary bypass should be performed through the ascending aorta in order to decrease the likelihood of a retrograde dissection, which may extend with femoral artery perfusion. We have observed excellent diastolic augmentation despite subintima1 location of the balloon in the dissected aortic wall; thus, this complication does not preclude proper function of the balloon. Aortography may be required to confirm or rule out dissection. One should desist from attempting to introduce the balloon when strong resistance is encountered (Fig 2). We have recently been Fig 2 . Roentgenogram of the abdomen showing an evaluating the use of a central-lumen balloon intraaortic balloon kinked in the abdominal aorta that can be passed over a guide wire under following an insertion that met with resistance due to atheromatous disease in the aorta. Fluoroscopic fluoroscopic control and through which con- and pressure monitoring through a centrul lumen tinuous monitoring of arterial pressure and in- kelps to avoid these difficulties of balloon insertion. jection of contrast material can be performed Our experience underlines the importance [31]. Such a balloon has allowed us to provide counterpulsation to several patients with severe of IABC for temporary support of patients aortoiliac atheromatous disease in whom dissec- acutely ill with cardiac disease. Stabilization of the hemodynamic state allows time for diagnostion would have been a distinct possibility. Systemic infection is extremely serious and tic procedures and selection of the appropriate calls for immediate removal of the balloon. A therapeutic course. In patients with poor carlocalized wound infection often can be con- diovascular function following a cardiac operatrolled with debridement and local wound care, tion, IABC reduces the requirement for but 2 of the 8 patients who had this complication catecholamines and the ensuing tachyarrequired arterial reconstruction after removal of rhythmias and other side-effects. It also increases the salvage rate among these patients by infected Dacron material. Abdominal pain following balloon insertion interrupting the vicious cycle of progressively is relatively common. If this symptom occurs, deteriorating myocardial function. Awareness the patient should be observed very carefully of the complications of balloon insertion should with particular attention to bowel sounds, ab- help to decrease their incidence. dominal rigidity, and leukocytosis. In our entire series we have observed 1instance of gangrene References of the cecum with perforation; fortunately, early 1. Alpert J, Bhaktan EK, Gielchinsky I, et al: Vascular complications of intra-aortic balloon pumprecognition and immediate right colectomy reing. Arch Surg 111:1190,1976 sulted in the patient’s survival. Two deaths due 2. Baron DW, O’Rourke MF: Long-term results of to gangrenous bowel were reported by Pace and arterial counterpulsation in acute severe cardiac associates [26] in their series of 104 patients refailure complicating myocardial infarction. Br Heart J 38:285, 1976 ceiving IABC.
557 Beckman et al: IntraaorticBalloon Counterpulsation
3. Barsamian EM, Goldman M, Crane C, et al: Femorofemoral bypass graft in intra-aortic balloon counterpulsation. Arch Surg 111:1070, 1976 4. Bernstein EF, Murphy AE: The importance of pulsation in preventing thrombosis from intra-aortic balloons. J Thorac Cardiovasc Surg 62:950, 1971 5. Bertolasi CA, Troge JE, Carreno CA, et al: Unstable angina-prospective and randomized study of its evolution, with and without surgery: preliminary report. Am J Cardiol 33:201, 1974 6. Bolooki H, Williams W, Thurer R, et al: Clinical and hemodynamic criteria for use of the intraaortic balloon pump in patients requiring cardiac surgery. J Thorac Cardiovasc Surg 72:756, 1976 7. Buckley MJ, Craver JM, Gold HK, et al: Intraaortic balloon pump assist for cardiogenic shock after cardiopulmonary bypass (abstract). Circulation 46:Suppl 2:76, 1972 8. Buckley MJ, Craver JM, Gold HK, et al: Intraaortic balloon pump assist for cardiogenic shock after cardiopulmonary bypass. Circulation 48:Suppl 3:90, 1973 9. Buckley MJ, Mundth ED, Daggett WM, et al: Surgical management of ventricular septa1 defects and mitral regurgitation complicating acute myocardial infarction. Ann Thorac Surg 16:598, 1974 10. Conti CR, Brawley RK, Griffith LSC, et al: Unstable angina pectoris: morbidity and mortality in 57 consecutive patients evaluated angiographically. Am J Cardiol 32:745, 1973 11. Dunkman WB, Leinbach RC, Buckley MJ, et al: Clinical and hemodynamic results of intra-aortic balloon pumping and surgery for cardiogenic shock. Circulation 46:465, 1972 12. Gazes PC, Mobley EM, Faris HM, et al: Preinfarctional (unstable) angina: a prospective study: ten years follow-up: prognostic significance of electrocardiographic changes. Circulation 48:331, 1973 13. Geha AS: The role of coronary artery bypass surgery in the management of ischemic heart disease. Conn Med 40:530, 1976 14. Geha AS, Baue AE, Krone RJ, et al: Surgical treatment of unstable angina by saphenous vein and internal mammary artery bypass grafting. J Thorac Cardiovasc Surg 71:348, 1976 15. Gold HK, Leinbach RC, Buckley MJ, et al: Refractory angina pectoris, follow-up after intra-aortic balloon pumping and surgery. Circulation 54:Suppl 3:41, 1976 16. Goldman BS, Walker P, Gunstensen J, et al: Intra-aortic balloon pump assist: Adjunct to surgery for left ventricular dysfunction. Can J Surg 19:128, 1976 17. Graham AF, Miller DC, Stinson EB, et al: Surgical treatment of refractory life-threatening ventricular tachycardia. Am J Cardiol32:909, 1973 18. Hammond GL, Poirier RA: Surgical management for acute coronary insufficiency with three years’ follow-up. J Thorac Cardiovasc Surg 69:625, 1975
19. Kaiser GC, DiMarco J, Barer HB, et al: Intra-aortic balloon assistance. Ann Thorac Surg 21:487,1976 20. Krakauer JS, Rosenbaum A, Freed PS, et al: Clinical management ancillary to phase-shift balloon pumping in cardiogenic shock. Am J Cardiol 27:123, 1971 21. Miller DC, Cannom DS, Fogarty TJ, et al: Saphenous vein coronary artery bypass in patients with ”preinfarction angina.” Circulation 47:234, 1972 22. Moore EE, Broecker B, DeMeules JE, et al: Removal of intraaortic balloon without vascular complications. Ann Thorac Surg 21:566, 1976 23. Mundth ED: Mechanical and surgical interventions for the reduction of myocardial ischemia. Circulation 53:Suppl 1:176, 1976 24. Mundth ED, Buckley MJ, DeSanctis RW, et al: Surgical treatment of ventricular irritability. J Thorac Cardiovasc Surg 66:943, 1973 25. Ortiz AF, Lukban SB, Jurado RA, et al: The use of vein allografts as sidearms for intraaortic balloon insertion. Ann Thorac Surg 19:574, 1975 26. Pace P, Tilney N, Couch N, et al: Peripheral arterial complications of intra-aortic balloon counterpulsation. Circulation 54:Suppl 2:13, 1976 27. Scanlon PJ, Nemickas R, Moran JF, et al: Accelerated angina pectoris: clinical, hemodynamic, arteriographic and therapeutic experience in 83 patients. Circulation 47:19, 1973 28. Scanlon PJ, O’Connell J, Johnson SA, et al: Balloon counterpulsation following surgery for ischemic heart disease. Circulation 54:Suppl 3:90, 1976 29. Scheidt S, Wilner G, Mueller H, et al: Intra-aortic balloon counterpulsation in cardiogenic shock: report of a cooperative trial. N Engl J Med 288:979, 1973 30. Stewart S, Biddle T, DeWeese J: Support of the myocardium with intra-aortic balloon counterpulsation following cardiopulmonary bypass. J Thorac Cardiovasc Surg 72:109, 1976 31. Wolfson S, Geha AS, Hammond GL, et al: Preliminary report: modification of intra-aortic balloon for pressure measurement, contrast injection and guide wire passage. Am J Cardio139:260,1977
Discussion
DR. JOHN c. M C CABE (New York, NY): Dr. Beckman’s experience is similar to ours at Cornell and to that of other published series. There is little doubt that IABC is effective in relieving refractory ischemia, as demonstrated by the excellent results in the group with acute coronary insufficiency. The major advantage here is the ability to convert an unstable state to a controlled situation in which patients can be studied and operated on semielectively and safely. Cardiogenic shock after myocardial infarction remains the primary indication for use of counterpulsation. In contrast to the New Haven series, our experience has been that survival is rare in the group treated with medical therapy and IABP alone. For that reason
558 The Annals of Thoracic Surgery Vol 24 No 6 December 1977
we recommend studying these patients as soon as they can be stabilized on counterpulsation. Of the operable patients in this group-those who have mechanical defects or bypassable coronary lesions-we have salvaged 40% with emergency operations. In an attempt to evaluate the problem of complications with IABC, we recently reviewed 100 consecutive cases of attempted balloon insertion. Inserting the balloon was difficult because of aortoiliac atherosclerosis in 27% of the patients, and it proved impossible by the groin approach in 21%. Three patients subsequently had the balloon inserted through the ascending aorta. Although this problem is related to the diffuse nature of atherosclerosis, it also correlates with age, in that the average age of the group who had successful insertion was 57 years compared with 64 years in the group in whom insertion could not be done. We saw a higher incidence of complications in this group of 100 patients: 23% developed complications compared with 13% in the Yale series. If those patients who did not survive to have the balloon removed were excluded, this figure would be higher. As in the present series, dissection (7 patients) and ischemic extremity (10 patients) were most commonly seen. Four of the dissections were unsuspected and were found at catheterization or postmortem examination. In each instance, the patient was successfully counterpulsed despite the balloon being positioned in a false lumen. Most dissections occurred in the group with cardiogenic shock, in whom there is a tendency to push harder to accomplish balloon positioning. No patients died from the complication of dissection in our series. However, there were 2 deaths related to balloon pumping: 1was from perforation of the common iliac artery and the second from infection of an ascending aortic balloon Dacron graft conduit and eventual hemorrhage at the suture line after graft removal. I don’t think this complication has been reported. These complications must necessarily be weighed against the lesser indications for IABC, particularly its prophylactic use in patients with left main coronary artery occlusion without refractory ischemia and in those with compromised left ventricular function. I would like to ask Dr. Beckman if he includes weaning from propranolol as one of the indications for IABC. We no longer try to discontinue propranolol in ischemic patients; therefore, we don’t believe this should be included as an indication for the use of IABC . D R . w . GERALD RAINER (Denver, CO): Dr. Beckman’s results are extremely good considering the classification of patients in the study. I was most impressed with his salvage of patients in whom dissection had occurred. We have not been so fortunate. Our indications for pumping are a bit more rigid, and we have
had 4 dissections in a series of 50 consecutive patients undergoing IABC. We have not saved any of these 4 patients, and it may be that we were not aggressive enough in identifying the problem early and in removing the balloon. We also were impressed by the fact that the balloon functioned well in spite of its extraluminal location. In 2 additional patients we had a complication that really relates to material and durability-a split in the balloon catheter corresponding to its location at about the aortoiliac position, probably caused by pulsation against an extremely rigid atheromatous plaque. I would like to ask Dr. Beckman if he could elaborate further on the use of an open-lumen balloon to facilitate passage in difficult patients. DR. WILLARD M . DAGGETT (Boston, MA): Dr. Beckman and his co-workers have carefully enumerated the types of problems one can encounter in the course of using the balloon pump. An observation that stands out in my mind, however, is the infrequency of complications with the device, especially considering the incidence of peripheral arterial disease in patients who require this type of assistance. There is one area of management in which I would like to register a differing opinion, and that concerns the group in cardiogenic shock. If one is going to operate on these patients-and certainly they are a difficult group at best-it must be done early, before all the person’s assets are dissipated. This is particularly true with patients who have mechanical complications such as ventricular septa1 defect or mitral regurgitation. In this setting the balloon will reverse the patient’s hemodynamic slide only temporarily, and to achieve success in this group of patients one must operate while the conditions are right. I would like to ask Dr. Beckman how he is following survivors in the cardiogenic shock group who were treated solely with the balloon. We and others have observed a rather poor outlook in this group in the year after hospital discharge. Are you electively studying and operating on these patients later on, after they have recovered?
(Cincinnati, OH): We have found that postoperative limb ischemia seems to occur more frequently in patients in whom blood flow around the balloon catheter was markedly diminished at the time the balloon was inserted. Dilation of the iliac and femoral arteries leads to brisk flow past the catheter, and we achieve this by positioning the balloon in the pelvic vessels and allowing it to pulsate a few times before advancing it into the thoracic aorta. This maneuver has led to an apparent decrease in the incidence of limb ischemia associated with use of the intraaortic balloon. DR. JOHN B. FLEGE, JR.
DR. BECKMAN: Dr. McCabe and Dr. Daggett have raised a question about the discrepancy between their results and ours with surgical treatment of patients in
559 Beckman et al: Intraaortic Balloon Counterpulsation
cardiogenic shock secondary to acute myocardial infarction. I think Dr. Daggett has outlined well the reason why our surgical approach was less successful. When we coupled IABC with operative intervention in this group of patients, the operation was performed several days after the institution of IABC. This interval was necessary to determine that these patients were balloon dependent, but by then their condition had deteriorated to the point where it jeopardized the ultimate result of the operation. The late outcome in our patients in this group treated with IABC only has not been too disappointing, however. Six of the 8 early survivors are still alive, 2 died of late cardiac failure. The 6 survivors seem to be relatively asymptomatic; most are in Functional Class 11. Dr. Rainer raised the question of deaths resulting from aortic dissection subsequent to introduction of
the balloon. We consider it a stroke of luck not to have had any deaths from this complication of balloon insertion among 11 patients. We have learned, however, that when we feel the balloon advancing against continued resistance, we should desist from further attempts at blind passage. When confronted with this situation outside the operating room, we resort to the central-lumen balloon developed by the Avco Company in conjunction with Dr. Wolfson of our cardiology department. A guide wire is introduced under fluoroscopic control and then is followed by the central-lumen balloon. In fact, when we anticipate difficultiessecondary to aortoiliac occlusive disease in a patient having a rather elective balloon introduction, we would prefer to perform it from the beginning under fluoroscopic control with this luminal balloon.
Notice from the Editor and the Editorial Board The Editor and members of the Editorial Board are grateful for the assistance given in the review of certain manuscripts during the past year by the following persons:
John G . Batsakis, M.D. Ann Arbor, MI
Herbert Maier, M.D. New York, NY
Douglas M. Behrendt, M.D. Ann Arbor, MI
Mark B. Orringer, M.D. Ann Arbor, MI
David A. Blumenstock, M.D. Cooperstown, NY
Toronto, Ont, Canada
F. Griffith Pearson, M.D.
R. Randolph Bradham, M.D. Charleston, SC
John A. Penner, M.D.
Peter J. Cohen, M.D. Ann Arbor, MI
Mark M. Ravitch, M.D.
Arnold G. Coran, M.D.
J. Gordon Scannell, M.D.
Ann Arbor, MI
Boston, MA
Ann Arbor, MI
Pittsburgh, PA
William Fry, M.D.
Arthur B. Simon, M.D.
Dallas, TX
Ann Arbor, MI
Hermes C. Grillo, M.D. Boston, MA
James C. Stanley, M.D. Ann Arbor, MI
Kenneth A. Kooi, M.D. Ann Arbor, MI
Martha R. Westerberg, M.D. Ann Arbor, MI
