Vascular Complications of Intra-aortic Balloon Pumping Ezhuthachan K. Bhaktan, MD; Isaac Gielchinsky, MD; Donald K. Brief, MD; Victor Parsonnet, MD
Joseph Alpert, MD; Bruce J.
Brener,
\s=b\ Vascular injury or occlusion from intra-aortic balloon pumping (IABP) that results in actual or potential limb ischemia occurs more frequently than reported. In a series of 79 IABP patients, 36 lived long enough to have the balloon catheter removed; thirteen (36%) of them had vascular complications. The complications were in three patients with an injury at the insertion site, eight patients with arterial thromboses, and two with arterial occlusion by the large balloon catheter. Local artery revision, thrombectomy alone, or thrombectomy with femorofemoral cross-over grafting was required in 11 patients. Femorofemoral crossover graft was utilized when arterial occlusion would have ordinarily required premature balloon removal or when immediate arterial occlusion by the catheter was recognized at the time of balloon insertion. This was preferable to transferring, replacing, or discontinuing IABP, since the same factors that led to thrombosis in the first place would have eventually come into play again. Patients should be observed frequently and have Doppler limb pulse determinations every four hours to avoid ischemic catastrophies. Proper IABP weaning and the use of a Fogarty catheter at the time of balloon removal is mandatory to prevent complications. Femorofemoral crossover graft is indi-
cated for ischemic limbs when IABP must be continued.
(Arch Surg 111:1190-1195, 1976) balloon pumping (IABP) is simple, relatively and therapeutically effective. It is the most used cardiac assist device for patients with cardiogenic shock or low flow states that may accompany cardiac surgery.1 Over 3,000 instances of IABP utilizing only one variety of systems have already been reported.(Currently, there are commercially available in the United States four different pump monitoring consoles and five types of aortic balloons. ) The number of patients subject to IABP predictably will increase as improved survival statistics are recognized, cardiogenic shock is treated earlier and more aggressively, and the volume of coronary artery surgery increases.
Intra-aorti safe, c frequently
for publication July 9, 1976. From the Peripheral Vascular and Cardiovascular Surgical Service, Newark Beth Israel Medical Center, and the New Jersey College of Medicine and Dentistry at Newark. Read before the 24th scientific meeting of the International Cardiovascular Society, Albuquerque, NM, June 18, 1976. Reprint requests to Department of Surgery, Newark Beth Israel Medical Center, 201 Lyons Ave, Newark, NJ 07112 (Dr Alpert).
Accepted
MD; Lawrence Gilbert, MD;
Most IABP reports focus on hemodynamics, clinical indications, and therapeutic effects, but few have been directed primarily to the potential or actual vascular complications.1 ' Some authors consider these iatrogenic complications as incidental and trivial, an attitude that prevails to a point where the complications are ill-defined and understated1 (H. Bolooki, MD, oral communication, 1976). Consequently, a review of the IABP experience at the Newark (NJ) Beth Israel Medical Center was under¬ taken to define a vascular complication, determine its incidence, seek out common causative factors, and propose recommendations for management that will allow contin¬ ued IABP. ·-
SUBJECTS AND METHODS
During 16-month period (January 1975 through April 1976), 79 patients were assisted by IABP. Five additional patients were excluded due to unsuccessful balloon insertions. Intra-aortic balloon pumping was utilized in patients with myocardial infarcts and refractory cardiogenic shock unresponsive to short-term medical treatment, unstable cardiodynamic states during and after cardiac catheterization or coronary angiography, preopera¬ tively or intraoperatively impaired left ventricular function due to an ischemie myocardium, and refractory low cardiac outputs a
following cardiopulmonary bypass. The series comprised 61 men and 18 women ranging in age from 23 to 72 years (average, 54 years). Intra-aortic balloon pumping was maintained for 2 to 168 hours, with a mean of 35 hours. Pumping was effected by only one type of electronic control
system and unidirectional dual-chambered balloon with a catheter length of 117 cm and outside diameter of 0.4 cm (12 F). The femoral artery in the groin was exposed at the bedside or in the operating room; the type of anesthesia varied according to the patient's status. The balloon was inserted retrograde into the Table 1.—Indications for Intra-aortic Balloon
Pumping
No. of
Cardiogenic shock from myocardial infarction Angiography support, no
Patients
Failed
Lived
36
4
13
27
32 9 79
0 0 5
20
12
Died
surgery
Operative and perioperative support Bypass weaning Total
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1
36
(46%)
48
(54%)
Fig 1.—Angiogram of
an
external iliac
artery thrombosis with well-developed collateral
circulation.
Table 2.—Vascular No. of Patients
Complications
(n
=
Proximal thrombus Distal thrombus
in 13 Patients Potential
Medical"
Surgicalt
Local arterial injury or occlusion Without balloon
Ischemia 1
Ischemia
"Treated with with
4)
heparin. low-molecular-welght
Treatment
Endarterectomy
with
patch graft
local resection vein graft and In one None (angiography)
in two;
fasciotomy
Thrombectomy In one; no treatment (angiography) In one; exploration and fasciotomy In one Crossover graft In five; crossover graft and fasciotomy In one
In situ balloon
tTreated
Fig 2.—Angiogram of thrombotic occlu¬ sion of anterior tibial artery after balloon removal.
dextran 40.
thoracic aorta through a woven Dacron sidearm graft sutured to the femoral arteriotomy. Surgical patients received low-molecularweight dextran 40 or rectal aspirin. Nonsurgical patients were heparinized. Intra-aortic balloon pump weaning was by serial reduction of the balloon volume and pulsing the balloon on alternate beats. In surviving patients the balloon device was removed under local anesthesia in the operating room. After
extracting the balloon, a Fogarty catheter was inserted in both directions. The graft was then divided and oversewn at its base. All limbs containing the balloon were observed frequently for ischemie changes, and in recent months pulse status was followed with a Doppler probe (this is now routine). Angiography was performed when indicated by individual patient circumstances. We define an IABP vascular complication as any degree of
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Fig 3.—Angiogram of functioning femorofemoral pumping is still in progress.
crossover
aortic balloon
graft
while intra-
Fig 4—Diagram of Fig 3. Common ligated In continuity when
was
femoral artery balloon was
removed.
arterial injury or occlusion that causes potential or actual limb ischemia. The complications may require cessation of IABP, transfer of the balloon catheter to the contralateral limb, angioplasty, thrombectomy, femorofemoral crossover grafting, or no treatment at all.
RESULTS
Seventy-nine patients underwent IABP (Table 1). Thir¬ patients with cardiogenic shock from myocardial infarction survived. Two nonsurgical patients were assisted during coronary angiography and lived; a third died when the catheter could not be inserted. Twenty of 32 patients who had preoperative or perioperative support lived. Of nine patients requiring IABP after cardiopulmonary bypass, only one survived. Thirty-six patients (46%) lived long enough to have the teen of 40
balloon removed, and 13 (36%) of them had
a
vascular
complication. Eight complications occurred in surgical
patients
who had received
40; the other five patients duration of IABP in
low-molecular-weight
dextran
heparinized. The mean the 13 patients with vascular compiiwere
cations was 43 hours, with a range of 1 to 120 hours. The mean duration of the 36 surviving IABP patients was 73 hours, with a similar range. Three patients had mechanical trauma at the insertion site (Table 2). Two required an endarterectomy and patch graft angioplasty, and in one a persistent foot drop developed postoperatively. The third had a segmental resection of the common femoral artery, an interposition vein graft, and a fasciotomy. Two procedures were done after the balloon was removed because the limb became ischemie, and the third was done at the time of removal when a potential problem was recognized. Thrombus was found invariably in the proximal iliac artery and sidearm graft and was removed with the balloon and a Fogarty catheter. One patient had an asymptomatic iliac artery thrombotic occlusion that did not require revascularization because of excellent collateral circulation (Fig 1). Distal thrombus was found after balloon removal on three occasions in symptomatic limbs (post-balloon angiography was not routine, so that the actual incidence of distal thrombotic occlusion could not be
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(Â)
DURING IABP RIGHT
LEFT
µ.i-t-i-R
^c\ (D
24 HOURS LATER
©
IABP WITH X-OVER GRAFT
-CATHETER
Fig 6.—Doppler pulse recordings during Intra-aortic balloon pumping (IABP) after femorofemoral crossover (X-over) graft. Note increased pulse volume amplitude. COMMENT
Intra-aortic balloon
pumping vascular complications in patients with sclerotic arteries whose borderline circulation is further impoverished by catheter encroachment on the arterial lumen. Many reports on IABP list these complications in a perfunctory fashion.';'" One author states that "vascular insufficiency of variable severity has been observed with some frequen¬ cy."' A review of reports of over 1,000 IABP patients uncovered only 25 vascular complications' (H. Bolooki, MD, R. Abel, MD, H. Siderys, MD, oral communication, 1976). This 47c occurrence is even less than the 10% to 16% usually given. Notably, these rates were calculated with the total number of balloon insertions and not patients surviving long enough to have the balloon removed. Scheldt and his associates, in a cooperative study of 87 patients,'5 reported 13 ischemie limb problems, for an incidence of 16%. Actually, this rate is 37% if the authors calculated it on the basis of 35 patients who lived long enough to have the balloon removed. That vascular complications of IABP are more common than reported in the literature is suggested by the 36% occurrence rate in our patients. Our experience with 79 patients leads us to believe that virtually every patient with an intra-aortic balloon pump who survives until balloon removal can have an actual or potential vascular problem. For example, in the 36 surviving patients, 23 (64%) had bland iliofemoral or distal thrombi that were easily removed with the aortic balloon and a Fogarty catheter. Had this thrombotic material not been removed, significant occlusion would have become manifest later occur
SIEGEL
predominantly
'"
Fig 5.—Diagram of occluding catheter that required femorofem¬ graft at time of insertion.
oral crossover
ascertained). Two patients had thrombectomy with a Fogarty catheter, one of whom required a fasciotomy to relieve compartmental ischemia (Fig 2). The other patient had a mild compartmental syndrome that did not require a fasciotomy. In the third patient a neuropathy due to thrombotic occlusion of the peroneal artery developed. No attempt was made to remove the clot in view of the minimal symptoms. In six patients, complications developed while IABP was in progress. In four, ischemie changes manifested by pain, pallor, limb cyanosis, mottling, and pulse disappearance occurred. To restore circulation and continue IABP, the four patients underwent femorofemoral crossover grafting (Fig 3 and 4). One patient required a fasciotomy for anterior compartment ischemia. The other two patients underwent immediate femoro¬ femoral crossover grafting to avert potential limb ischemia while IABP was maintained. These patients had small common femoral and iliac arteries that were totally occluded by the 12 F catheter balloon (Fig 5). No crossover graft wound became infected. Limb loss did not occur in any of the 13 patients with vascular complica¬ tions. One death could be attributed to a vascular compli¬ cation. This patient had a thrombotic occlusion and, follow¬ ing arterial exploration and a fasciotomy, fatal sepsis
developed.
on.'"·17
The 13 serious complications included mechanical trauma to sclerotic arteries at balloon insertion sites in three patients, thrombotic occlusion in eight patients, and arterial occlusion by the catheter in the remaining two. Thrombosis was managed by thrombectomy alone in two
patients, thrombectomy combined with femorofemoral crossover graft in four patients, and prophylactic crossover
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graft in two patients when occlusion of the artery was recognized at the time of catheter insertion. Crossover grafting was expedient and logical in these circumstances because limb ischemia was reversed, and especially because IABP was never interrupted.1"2" Crossover grafting is preferable to transfer of the balloon to the opposite side or to ipsilateral replacement, because those factors that led to thrombosis in the first placed would eventually come into play again. It is clear that the thrombus develops around the shaft of the catheter in the iliac artery, and not to any extent on the aortic balloon. It is this fact that permits successful use of femorofemoral crossover graft. Although massive thrombosis of the aorta is a potential complication, it was not encountered in any of our patients. Two patients with thrombotic occlusion did not require thrombectomy. One had a mild neuropathy due to peroneal occlusion, and the other had no ischemie symptoms despite iliac occlusion. Only six of the 13 patients left the hospital; two of these had minimal but persistent symptoms. Ischemie complications were severe enough in six patients to produce an anterior compartment syndrome, and three required fasciotomies. It is apparent that recognition of many of the thirteen problems was late because patients were often sedated, anesthetized, unconscious, or in shock, and could not communicate the early symptoms of limb ischemia. Therefore, it is important that all patients with IABP be examined frequently and that the pulse status be ascertained every four hours by the Doppler ultrasound probe (Fig 6). Prophylactic femorofemoral crossover grafts should be used immediately when arterial occlusion by the catheter is recognized at time of balloon insertion, and should always be used whenever thrombosis would ordinarily dictate prematue balloon removal. With the passage of time, the number of IABP patients will increase, as will the number and variety of vascular complications. We believe that the incidence and conse¬ quences of ischemie complications can be substantiallyreduced if these suggestions in IABP management are followed: During IABP Frequent observation
Doppler examination every four hours Angiography as indicated Femorofemoral crossover graft as required After IABP Doppler examination Angiography as indicated
Thrombectomy Local revascularization
References 1. Bregman D, Goetz RH: Clinical experiences with a new cardiac assist device. J Thorac Cardiovasc Surg 62:577-591, 1971. 2. Bregman D: Management of patients undergoing intra-aortic balloon pumping. Heart Lung 3:916-928, 1974. 3. Foster ED, Vacavanur AS, Vito L, et al: Response to intra-aortic balloon pumping. Am J Surg 129:464-471, 1975. 4. Weber KT, Janicki JS: Intra-aortic balloon counterpulsation: A collective review. Ann Thorac Surg 17:602-636, 1974. 5. Master TN, Harbold NB, Hall DG, et al: Intra-aortic balloon counterpulsation in acute cardiogenic shock. NC Med J 36:157-161, 1975.
6. Bolooki H, Williams W, Thorer RJ, et al: Clinical and hemo-dynamic criteria for use of intra-aortic balloon pump (IABP) in cardiac surgery patients. J Thorac Cardiovasc Surg, to be published. 7. Bregman D, Kripke DC, Cohen MN, et al: Clinical experience with the unidirectional dual-chambered intra-aortic balloon assist. Circulation 43(suppl 1):82-89, 1971. 8. Pastellopoulos AE, Cullum PA: Intra-aortic balloon assist for cardiogenic shock. J Cardiovasc Tech 16:21-30, 1974. 9. Lamberti JJ Jr, Cohn LH, Lesch M, et al: Intra-aortic balloon counterpulsation. Arch Surg 109:766-771, 1974. 10. Buckley MJ, Leinbach RC, Kastor JA, et al: Hemodynamic evaluation of intra-aortic balloon pumping in man. Circulation 42(suppl 2):130-136, 1970. 11. Cleveland JC, Lefemine AA, Madoff I, et al: Role of intra-aortic balloon counterpulsation in patients undergoing cardiac operations. Ann Thorac Surg 21:652-660, 1975. 12. Buckley MJ, Craver JM, Gold HK, et al: Intra-aortic balloon pump assist for cardiogenic shock after cardiopulmonary bypass. Circulation 48(suppl 3):90-94, 1973. 13. Dunkman WB, Leinbach RC, Buckley MJ, et al: Clinical and hemodynamic results of intra-aortic balloon pumping and surgery for cardiogenic shock. Circulation 46:465-477, 1972. 14. Kantrowitz A, Krakauer JS, Rosenbaum A, et al: Phase-shift balloon pumping in medically refractory cardiogenic shock. Arch Surg 99:739-743, 1969. 15. Scheidt S, Wilner G, Mueller H, et al: Intra-aortic balloon counterpulsation in cardiogenic shock: Report of a cooperative trial. N Engl J Med 288:979-984, 1973. 16. Bernstein EF, Murphy AE: The importance of pulsation in preventing thrombosis from intra-aortic balloons. J Thorac Cardiovasc Surg 62:950-956, 1971. 17. Saini VK, Berger RL: Technique of aortic balloon catheter deployment with the use of a Fogarty catheter. Ann Thorac Surg 14:440-442, 1972. 18. Alpert J, Brief DK, Parsonnet V: Vascular restoration for aortoiliac occlusion. J Newark Beth Israel Hosp 18:4-8, 1967. 19. Brief DK, Alpert J, Parsonnet V: Crossover femorofemoral grafts. Arch Surg 105:889-894, 1972. 20. Brief DK, Brener BJ, Alpert J, et al: Crossover grafts followed up five years or more. Arch Surg 110:1294-1299, 1975.
Discussion Gerald Rainer, MD, Denver: My comments will be directed to a group of 34 patients who have undergone 36 intra-aortic balloon pump procedures. We have had 18 deaths, but most of these have reflected the serious condition of the patients. The average age of the women in this group was 56, and of the men, 60; both groups manifest other forms of peripheral vascular disease. Seven of the balloons were inserted preoperatively. Six were inserted for cardiogenic shock and the patients did not undergo surgery. Five were inserted in the postoperative period, and 16 were inserted during surgery itself, none for prophylactic reasons but only for patients who could not be weaned from
cardiopulmonary bypass.
Three femoral endarterectomies were necessary at the time of insertion of the balloon, and five patients underwent catheter thrombectomy during the intra-aortic balloon pumping. We did not employ the crossover grafting as mentioned by Dr Alpert. One patient required femoral artery patch angioplasty one year post¬ operatively. Three aortic dissections led to death in this particular group. In one patient, the catheter was outside of the true lumen with the tip of the catheter in the upper portion of the thoracic aorta. The balloon catheter entry was really quite low in the abdominal aorta. This patient underwent balloon pumping for three days and actually sustained good support from the balloon pump in spite of the fact that the balloon was extraluminal. We did have one incident of a catheter laceration from a severe athero¬ sclerotic plaque at the iliac artery origin. Bruce Patón, MD, Denver: I also want to describe two patients, one with a dissection almost identical to the one just reported by Dr Rainer. The first patient underwent balloon pumping for 2'/2 days with only moderate success. There was some change in the
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arterial pressure wave, but we were incapable of inflating the balloon as adequately as it should have been inflated. The other patient had a free perforation at the level of the iliac artery into the peritoneum, which, needless to say, resulted in massive and immediate hemorrhage. From these two experiences, I would suggest that if you have a thoracic balloon that appears to be in good position radiologically but that, for various ill-defined reasons, is not producing the desired result, you should consider the possibility of it lying outside the lumen of the aorta; if within a very few minutes of inserting the balloon there is a catastrophic fall in blood pressure, then an immediate roentgenogram may indicate that the balloon is lying in the free peritoneal cavity, in which case, of course, appropriate surgical steps have to be taken. Hushang Javid, MD, Chicago: Our experience in Chicago at Presbyterian-St Luke's Hospital is quite similar to that of Dr Alpert and colleagues. We have had 68 patients with a salvage rate of 35%. In this group we have seen eight vascular complications; in none was amputation of the lower extremity was necessary. We have done local endarterectomies and patch graftings as they described. In one case the patient was rather critically ill and died from pump failure, and thrombosis of the abdominal aorta was found at autopsy. In another case, a 66-year-old man was admitted to the Medical Intensive Care Unit. He suffered cardiac arrest shortly after arrival, and during the resuscitative measures an intra-aortic catheter was inserted. It was impossible to advance the tip of the catheter beyond the midthoracic level. Following the insertion of the catheter and the circulatory support, he responded extremely well and remained totally dependent on the balloon pumping for 21 days. A roentgenogram obtained after 20 days showed that the catheter had remained in place and there was no evidence of any complications. We decided to obtain coronary angiograms, since it was not possible to wean the patient off the balloon pumping; the coronary angiograms revealed no surgical target. The patient's condition deteriorated immediately postoperatively and he died within 12 hours. The catheter was found to be outside of the intima in a dissected lumen between the intima and the outer layers. There was no periaortic bleeding and no intraluminal clots. Karl Karlson, MD, Providence, RI: I would like to report our experience with peripheral vascular complications in 110 patients in whom we inserted balloons. No surviving patients have symp¬ tomatic arterial insufficiency. We had 15 other patients in whom we did not insert the balloon successfully. The 14 patients who survived and were discharged in that group of 15 did not have any ischemie complications. Seventy-one of the patients had balloons inserted prior to aortocoronary bypass for impending infarction, unstable angina, left main stenosis with severe ischemia, or severe myocardial dysfunction. There were two hospital deaths in these 71 patients, and none of the survivors have had symptomatic arterial insuffi¬
ciency postoperatively. The two patients who had infection at the insertion site are interesting. The first patient had an overt, apparently superficial groin wound infection that apparently healed, and he was discharged from the hospital. He bled from the femoral arteriotomy site and the wound one month postoperatively, requiring repair of the femoral artery. Now, three years later, he is asymptomatic. The other patient had the sleeve graft replaced with a vein patch in the face of persistent bacteremia. The bacteremia cleared up and the patient is well. In our present practice, we heparinize our patients before insertion of the balloon and, insofar as possible, continue infusion of heparin until removal of the balloon. The insertion of the balloon should be gentle, with timidity considered to be a surgical
virtue under the circumstances. Arteriography is helpful in certain patients to demonstrate which side the iliofemoral lumen is best. Certainly, we agree with Dr Alpert that intra-aortic balloon pumping is life-saving, that it may have serious complications, and that our job is to prevent these complications insofar as possi¬ ble. George Kaiser, MD, St Louis: I think Dr Alpert has brought up the most common complication of intra-aortic balloon pumping. Our experience would tend to support this. We recently reviewed our series of 99 patients treated with intra-aortic balloon pumping. The greatest number of complications are associated with the site of insertion. These have not caused any significant difficulties in management. They have been relatively easily managed by local procedures. We have not used crossover grafts. There have been occasional instances in which we have had to do minor revisions at the arteriostomy site. If the patient has been perfused through a transverse femoral arteriotomy, it is more difficult to suture a graft. We would prefer to use a vertical arteriotomy. If one is unable to insert the balloon from below, it can be inserted through the aortic arch. This has been done successfully by my associate, H. B. Barner. He attached a long graft and then removed the intra-aortic balloon a few days later under local anesthesia, without having to do a thoracotomy.
I would draw your attention to two of our patients who had unexplained peroneal palsy. These patients had good peripheral pulses with the intra-aortic balloon in place and good pulses following this. This did not appear to arise from arterial insuffi¬ ciency. Both of these patients had resolution with supportive therapy. We are somewhat at a loss to totally explain this. I would ask Dr Alpert if he has seen this problem and whether he has any thoughts as to its cause. Hooshang Bolooki, MD, Miami: Dr Alpert has brought up an important subject, especially for that group who are using intraaortic balloon pump frequently. Our experience in Miami is with 157 patients who had intra-aortic balloon pumping. Ninety patients, or 57%, were long-term survivors, although 120 (76%) lived for longer than five days. Vascular complications occurred in nine patients. Two had claudication without arterial obstruction. We have had two limbs lost, one of them in a patient with cardiogenic shock and the other in a patient who required emer¬ gency intra-aortic balloon pump after surgery. I must say in both cases the reason for limb loss was low blood flow distally due to low cardiac output, and there was no way we could prevent that. Probably in these patients and five others who required femoral thrombectomy, a crossover graft would have been helpful. Other¬ wise, we don't really think in all balloon pump patients such a procedure should be done. Dr Alpert: It becomes apparent that as these gentlemen report their complications, the occurrence rate is also more than that reported in the literature. In a review of over 1,000 cases of intraaortic balloon pumping, no more than 25 complications were reported-roughly 4%. Drs Rainer, Patón, and Javid give a compli¬ cation rate (just with quick figuring) of approximately 30% to 33% on patients who survived. None of the discussants made mention of the number of balloons that had to be removed because of ischemia, or had to be transferred to the contralateral limb. We include these in our definition of "complication." Dr Kaiser, I certainly agree with you. We had six patients who had some degree of anterior compartment syndrome, three of whom required a fasciotomy. We believe that this is due to late recognition of those patients with distal thrombotic occlusive complications. Consequently, the plea for the use of the Doppler and frequent monitoring, virtually every four hours.
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Joseph Alpert, MD; Bruce J.
Brener,
\s=b\ Vascular injury or occlusion from intra-aortic balloon pumping (IABP) that results in actual or potential limb ischemia occurs more frequently than reported. In a series of 79 IABP patients, 36 lived long enough to have the balloon catheter removed; thirteen (36%) of them had vascular complications. The complications were in three patients with an injury at the insertion site, eight patients with arterial thromboses, and two with arterial occlusion by the large balloon catheter. Local artery revision, thrombectomy alone, or thrombectomy with femorofemoral cross-over grafting was required in 11 patients. Femorofemoral crossover graft was utilized when arterial occlusion would have ordinarily required premature balloon removal or when immediate arterial occlusion by the catheter was recognized at the time of balloon insertion. This was preferable to transferring, replacing, or discontinuing IABP, since the same factors that led to thrombosis in the first place would have eventually come into play again. Patients should be observed frequently and have Doppler limb pulse determinations every four hours to avoid ischemic catastrophies. Proper IABP weaning and the use of a Fogarty catheter at the time of balloon removal is mandatory to prevent complications. Femorofemoral crossover graft is indi-
cated for ischemic limbs when IABP must be continued.
(Arch Surg 111:1190-1195, 1976) balloon pumping (IABP) is simple, relatively and therapeutically effective. It is the most used cardiac assist device for patients with cardiogenic shock or low flow states that may accompany cardiac surgery.1 Over 3,000 instances of IABP utilizing only one variety of systems have already been reported.(Currently, there are commercially available in the United States four different pump monitoring consoles and five types of aortic balloons. ) The number of patients subject to IABP predictably will increase as improved survival statistics are recognized, cardiogenic shock is treated earlier and more aggressively, and the volume of coronary artery surgery increases.
Intra-aorti safe, c frequently
for publication July 9, 1976. From the Peripheral Vascular and Cardiovascular Surgical Service, Newark Beth Israel Medical Center, and the New Jersey College of Medicine and Dentistry at Newark. Read before the 24th scientific meeting of the International Cardiovascular Society, Albuquerque, NM, June 18, 1976. Reprint requests to Department of Surgery, Newark Beth Israel Medical Center, 201 Lyons Ave, Newark, NJ 07112 (Dr Alpert).
Accepted
MD; Lawrence Gilbert, MD;
Most IABP reports focus on hemodynamics, clinical indications, and therapeutic effects, but few have been directed primarily to the potential or actual vascular complications.1 ' Some authors consider these iatrogenic complications as incidental and trivial, an attitude that prevails to a point where the complications are ill-defined and understated1 (H. Bolooki, MD, oral communication, 1976). Consequently, a review of the IABP experience at the Newark (NJ) Beth Israel Medical Center was under¬ taken to define a vascular complication, determine its incidence, seek out common causative factors, and propose recommendations for management that will allow contin¬ ued IABP. ·-
SUBJECTS AND METHODS
During 16-month period (January 1975 through April 1976), 79 patients were assisted by IABP. Five additional patients were excluded due to unsuccessful balloon insertions. Intra-aortic balloon pumping was utilized in patients with myocardial infarcts and refractory cardiogenic shock unresponsive to short-term medical treatment, unstable cardiodynamic states during and after cardiac catheterization or coronary angiography, preopera¬ tively or intraoperatively impaired left ventricular function due to an ischemie myocardium, and refractory low cardiac outputs a
following cardiopulmonary bypass. The series comprised 61 men and 18 women ranging in age from 23 to 72 years (average, 54 years). Intra-aortic balloon pumping was maintained for 2 to 168 hours, with a mean of 35 hours. Pumping was effected by only one type of electronic control
system and unidirectional dual-chambered balloon with a catheter length of 117 cm and outside diameter of 0.4 cm (12 F). The femoral artery in the groin was exposed at the bedside or in the operating room; the type of anesthesia varied according to the patient's status. The balloon was inserted retrograde into the Table 1.—Indications for Intra-aortic Balloon
Pumping
No. of
Cardiogenic shock from myocardial infarction Angiography support, no
Patients
Failed
Lived
36
4
13
27
32 9 79
0 0 5
20
12
Died
surgery
Operative and perioperative support Bypass weaning Total
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1
36
(46%)
48
(54%)
Fig 1.—Angiogram of
an
external iliac
artery thrombosis with well-developed collateral
circulation.
Table 2.—Vascular No. of Patients
Complications
(n
=
Proximal thrombus Distal thrombus
in 13 Patients Potential
Medical"
Surgicalt
Local arterial injury or occlusion Without balloon
Ischemia 1
Ischemia
"Treated with with
4)
heparin. low-molecular-welght
Treatment
Endarterectomy
with
patch graft
local resection vein graft and In one None (angiography)
in two;
fasciotomy
Thrombectomy In one; no treatment (angiography) In one; exploration and fasciotomy In one Crossover graft In five; crossover graft and fasciotomy In one
In situ balloon
tTreated
Fig 2.—Angiogram of thrombotic occlu¬ sion of anterior tibial artery after balloon removal.
dextran 40.
thoracic aorta through a woven Dacron sidearm graft sutured to the femoral arteriotomy. Surgical patients received low-molecularweight dextran 40 or rectal aspirin. Nonsurgical patients were heparinized. Intra-aortic balloon pump weaning was by serial reduction of the balloon volume and pulsing the balloon on alternate beats. In surviving patients the balloon device was removed under local anesthesia in the operating room. After
extracting the balloon, a Fogarty catheter was inserted in both directions. The graft was then divided and oversewn at its base. All limbs containing the balloon were observed frequently for ischemie changes, and in recent months pulse status was followed with a Doppler probe (this is now routine). Angiography was performed when indicated by individual patient circumstances. We define an IABP vascular complication as any degree of
Downloaded From: http://archsurg.jamanetwork.com/ by a New York University User on 06/21/2015
Fig 3.—Angiogram of functioning femorofemoral pumping is still in progress.
crossover
aortic balloon
graft
while intra-
Fig 4—Diagram of Fig 3. Common ligated In continuity when
was
femoral artery balloon was
removed.
arterial injury or occlusion that causes potential or actual limb ischemia. The complications may require cessation of IABP, transfer of the balloon catheter to the contralateral limb, angioplasty, thrombectomy, femorofemoral crossover grafting, or no treatment at all.
RESULTS
Seventy-nine patients underwent IABP (Table 1). Thir¬ patients with cardiogenic shock from myocardial infarction survived. Two nonsurgical patients were assisted during coronary angiography and lived; a third died when the catheter could not be inserted. Twenty of 32 patients who had preoperative or perioperative support lived. Of nine patients requiring IABP after cardiopulmonary bypass, only one survived. Thirty-six patients (46%) lived long enough to have the teen of 40
balloon removed, and 13 (36%) of them had
a
vascular
complication. Eight complications occurred in surgical
patients
who had received
40; the other five patients duration of IABP in
low-molecular-weight
dextran
heparinized. The mean the 13 patients with vascular compiiwere
cations was 43 hours, with a range of 1 to 120 hours. The mean duration of the 36 surviving IABP patients was 73 hours, with a similar range. Three patients had mechanical trauma at the insertion site (Table 2). Two required an endarterectomy and patch graft angioplasty, and in one a persistent foot drop developed postoperatively. The third had a segmental resection of the common femoral artery, an interposition vein graft, and a fasciotomy. Two procedures were done after the balloon was removed because the limb became ischemie, and the third was done at the time of removal when a potential problem was recognized. Thrombus was found invariably in the proximal iliac artery and sidearm graft and was removed with the balloon and a Fogarty catheter. One patient had an asymptomatic iliac artery thrombotic occlusion that did not require revascularization because of excellent collateral circulation (Fig 1). Distal thrombus was found after balloon removal on three occasions in symptomatic limbs (post-balloon angiography was not routine, so that the actual incidence of distal thrombotic occlusion could not be
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(Â)
DURING IABP RIGHT
LEFT
µ.i-t-i-R
^c\ (D
24 HOURS LATER
©
IABP WITH X-OVER GRAFT
-CATHETER
Fig 6.—Doppler pulse recordings during Intra-aortic balloon pumping (IABP) after femorofemoral crossover (X-over) graft. Note increased pulse volume amplitude. COMMENT
Intra-aortic balloon
pumping vascular complications in patients with sclerotic arteries whose borderline circulation is further impoverished by catheter encroachment on the arterial lumen. Many reports on IABP list these complications in a perfunctory fashion.';'" One author states that "vascular insufficiency of variable severity has been observed with some frequen¬ cy."' A review of reports of over 1,000 IABP patients uncovered only 25 vascular complications' (H. Bolooki, MD, R. Abel, MD, H. Siderys, MD, oral communication, 1976). This 47c occurrence is even less than the 10% to 16% usually given. Notably, these rates were calculated with the total number of balloon insertions and not patients surviving long enough to have the balloon removed. Scheldt and his associates, in a cooperative study of 87 patients,'5 reported 13 ischemie limb problems, for an incidence of 16%. Actually, this rate is 37% if the authors calculated it on the basis of 35 patients who lived long enough to have the balloon removed. That vascular complications of IABP are more common than reported in the literature is suggested by the 36% occurrence rate in our patients. Our experience with 79 patients leads us to believe that virtually every patient with an intra-aortic balloon pump who survives until balloon removal can have an actual or potential vascular problem. For example, in the 36 surviving patients, 23 (64%) had bland iliofemoral or distal thrombi that were easily removed with the aortic balloon and a Fogarty catheter. Had this thrombotic material not been removed, significant occlusion would have become manifest later occur
SIEGEL
predominantly
'"
Fig 5.—Diagram of occluding catheter that required femorofem¬ graft at time of insertion.
oral crossover
ascertained). Two patients had thrombectomy with a Fogarty catheter, one of whom required a fasciotomy to relieve compartmental ischemia (Fig 2). The other patient had a mild compartmental syndrome that did not require a fasciotomy. In the third patient a neuropathy due to thrombotic occlusion of the peroneal artery developed. No attempt was made to remove the clot in view of the minimal symptoms. In six patients, complications developed while IABP was in progress. In four, ischemie changes manifested by pain, pallor, limb cyanosis, mottling, and pulse disappearance occurred. To restore circulation and continue IABP, the four patients underwent femorofemoral crossover grafting (Fig 3 and 4). One patient required a fasciotomy for anterior compartment ischemia. The other two patients underwent immediate femoro¬ femoral crossover grafting to avert potential limb ischemia while IABP was maintained. These patients had small common femoral and iliac arteries that were totally occluded by the 12 F catheter balloon (Fig 5). No crossover graft wound became infected. Limb loss did not occur in any of the 13 patients with vascular complica¬ tions. One death could be attributed to a vascular compli¬ cation. This patient had a thrombotic occlusion and, follow¬ ing arterial exploration and a fasciotomy, fatal sepsis
developed.
on.'"·17
The 13 serious complications included mechanical trauma to sclerotic arteries at balloon insertion sites in three patients, thrombotic occlusion in eight patients, and arterial occlusion by the catheter in the remaining two. Thrombosis was managed by thrombectomy alone in two
patients, thrombectomy combined with femorofemoral crossover graft in four patients, and prophylactic crossover
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graft in two patients when occlusion of the artery was recognized at the time of catheter insertion. Crossover grafting was expedient and logical in these circumstances because limb ischemia was reversed, and especially because IABP was never interrupted.1"2" Crossover grafting is preferable to transfer of the balloon to the opposite side or to ipsilateral replacement, because those factors that led to thrombosis in the first placed would eventually come into play again. It is clear that the thrombus develops around the shaft of the catheter in the iliac artery, and not to any extent on the aortic balloon. It is this fact that permits successful use of femorofemoral crossover graft. Although massive thrombosis of the aorta is a potential complication, it was not encountered in any of our patients. Two patients with thrombotic occlusion did not require thrombectomy. One had a mild neuropathy due to peroneal occlusion, and the other had no ischemie symptoms despite iliac occlusion. Only six of the 13 patients left the hospital; two of these had minimal but persistent symptoms. Ischemie complications were severe enough in six patients to produce an anterior compartment syndrome, and three required fasciotomies. It is apparent that recognition of many of the thirteen problems was late because patients were often sedated, anesthetized, unconscious, or in shock, and could not communicate the early symptoms of limb ischemia. Therefore, it is important that all patients with IABP be examined frequently and that the pulse status be ascertained every four hours by the Doppler ultrasound probe (Fig 6). Prophylactic femorofemoral crossover grafts should be used immediately when arterial occlusion by the catheter is recognized at time of balloon insertion, and should always be used whenever thrombosis would ordinarily dictate prematue balloon removal. With the passage of time, the number of IABP patients will increase, as will the number and variety of vascular complications. We believe that the incidence and conse¬ quences of ischemie complications can be substantiallyreduced if these suggestions in IABP management are followed: During IABP Frequent observation
Doppler examination every four hours Angiography as indicated Femorofemoral crossover graft as required After IABP Doppler examination Angiography as indicated
Thrombectomy Local revascularization
References 1. Bregman D, Goetz RH: Clinical experiences with a new cardiac assist device. J Thorac Cardiovasc Surg 62:577-591, 1971. 2. Bregman D: Management of patients undergoing intra-aortic balloon pumping. Heart Lung 3:916-928, 1974. 3. Foster ED, Vacavanur AS, Vito L, et al: Response to intra-aortic balloon pumping. Am J Surg 129:464-471, 1975. 4. Weber KT, Janicki JS: Intra-aortic balloon counterpulsation: A collective review. Ann Thorac Surg 17:602-636, 1974. 5. Master TN, Harbold NB, Hall DG, et al: Intra-aortic balloon counterpulsation in acute cardiogenic shock. NC Med J 36:157-161, 1975.
6. Bolooki H, Williams W, Thorer RJ, et al: Clinical and hemo-dynamic criteria for use of intra-aortic balloon pump (IABP) in cardiac surgery patients. J Thorac Cardiovasc Surg, to be published. 7. Bregman D, Kripke DC, Cohen MN, et al: Clinical experience with the unidirectional dual-chambered intra-aortic balloon assist. Circulation 43(suppl 1):82-89, 1971. 8. Pastellopoulos AE, Cullum PA: Intra-aortic balloon assist for cardiogenic shock. J Cardiovasc Tech 16:21-30, 1974. 9. Lamberti JJ Jr, Cohn LH, Lesch M, et al: Intra-aortic balloon counterpulsation. Arch Surg 109:766-771, 1974. 10. Buckley MJ, Leinbach RC, Kastor JA, et al: Hemodynamic evaluation of intra-aortic balloon pumping in man. Circulation 42(suppl 2):130-136, 1970. 11. Cleveland JC, Lefemine AA, Madoff I, et al: Role of intra-aortic balloon counterpulsation in patients undergoing cardiac operations. Ann Thorac Surg 21:652-660, 1975. 12. Buckley MJ, Craver JM, Gold HK, et al: Intra-aortic balloon pump assist for cardiogenic shock after cardiopulmonary bypass. Circulation 48(suppl 3):90-94, 1973. 13. Dunkman WB, Leinbach RC, Buckley MJ, et al: Clinical and hemodynamic results of intra-aortic balloon pumping and surgery for cardiogenic shock. Circulation 46:465-477, 1972. 14. Kantrowitz A, Krakauer JS, Rosenbaum A, et al: Phase-shift balloon pumping in medically refractory cardiogenic shock. Arch Surg 99:739-743, 1969. 15. Scheidt S, Wilner G, Mueller H, et al: Intra-aortic balloon counterpulsation in cardiogenic shock: Report of a cooperative trial. N Engl J Med 288:979-984, 1973. 16. Bernstein EF, Murphy AE: The importance of pulsation in preventing thrombosis from intra-aortic balloons. J Thorac Cardiovasc Surg 62:950-956, 1971. 17. Saini VK, Berger RL: Technique of aortic balloon catheter deployment with the use of a Fogarty catheter. Ann Thorac Surg 14:440-442, 1972. 18. Alpert J, Brief DK, Parsonnet V: Vascular restoration for aortoiliac occlusion. J Newark Beth Israel Hosp 18:4-8, 1967. 19. Brief DK, Alpert J, Parsonnet V: Crossover femorofemoral grafts. Arch Surg 105:889-894, 1972. 20. Brief DK, Brener BJ, Alpert J, et al: Crossover grafts followed up five years or more. Arch Surg 110:1294-1299, 1975.
Discussion Gerald Rainer, MD, Denver: My comments will be directed to a group of 34 patients who have undergone 36 intra-aortic balloon pump procedures. We have had 18 deaths, but most of these have reflected the serious condition of the patients. The average age of the women in this group was 56, and of the men, 60; both groups manifest other forms of peripheral vascular disease. Seven of the balloons were inserted preoperatively. Six were inserted for cardiogenic shock and the patients did not undergo surgery. Five were inserted in the postoperative period, and 16 were inserted during surgery itself, none for prophylactic reasons but only for patients who could not be weaned from
cardiopulmonary bypass.
Three femoral endarterectomies were necessary at the time of insertion of the balloon, and five patients underwent catheter thrombectomy during the intra-aortic balloon pumping. We did not employ the crossover grafting as mentioned by Dr Alpert. One patient required femoral artery patch angioplasty one year post¬ operatively. Three aortic dissections led to death in this particular group. In one patient, the catheter was outside of the true lumen with the tip of the catheter in the upper portion of the thoracic aorta. The balloon catheter entry was really quite low in the abdominal aorta. This patient underwent balloon pumping for three days and actually sustained good support from the balloon pump in spite of the fact that the balloon was extraluminal. We did have one incident of a catheter laceration from a severe athero¬ sclerotic plaque at the iliac artery origin. Bruce Patón, MD, Denver: I also want to describe two patients, one with a dissection almost identical to the one just reported by Dr Rainer. The first patient underwent balloon pumping for 2'/2 days with only moderate success. There was some change in the
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arterial pressure wave, but we were incapable of inflating the balloon as adequately as it should have been inflated. The other patient had a free perforation at the level of the iliac artery into the peritoneum, which, needless to say, resulted in massive and immediate hemorrhage. From these two experiences, I would suggest that if you have a thoracic balloon that appears to be in good position radiologically but that, for various ill-defined reasons, is not producing the desired result, you should consider the possibility of it lying outside the lumen of the aorta; if within a very few minutes of inserting the balloon there is a catastrophic fall in blood pressure, then an immediate roentgenogram may indicate that the balloon is lying in the free peritoneal cavity, in which case, of course, appropriate surgical steps have to be taken. Hushang Javid, MD, Chicago: Our experience in Chicago at Presbyterian-St Luke's Hospital is quite similar to that of Dr Alpert and colleagues. We have had 68 patients with a salvage rate of 35%. In this group we have seen eight vascular complications; in none was amputation of the lower extremity was necessary. We have done local endarterectomies and patch graftings as they described. In one case the patient was rather critically ill and died from pump failure, and thrombosis of the abdominal aorta was found at autopsy. In another case, a 66-year-old man was admitted to the Medical Intensive Care Unit. He suffered cardiac arrest shortly after arrival, and during the resuscitative measures an intra-aortic catheter was inserted. It was impossible to advance the tip of the catheter beyond the midthoracic level. Following the insertion of the catheter and the circulatory support, he responded extremely well and remained totally dependent on the balloon pumping for 21 days. A roentgenogram obtained after 20 days showed that the catheter had remained in place and there was no evidence of any complications. We decided to obtain coronary angiograms, since it was not possible to wean the patient off the balloon pumping; the coronary angiograms revealed no surgical target. The patient's condition deteriorated immediately postoperatively and he died within 12 hours. The catheter was found to be outside of the intima in a dissected lumen between the intima and the outer layers. There was no periaortic bleeding and no intraluminal clots. Karl Karlson, MD, Providence, RI: I would like to report our experience with peripheral vascular complications in 110 patients in whom we inserted balloons. No surviving patients have symp¬ tomatic arterial insufficiency. We had 15 other patients in whom we did not insert the balloon successfully. The 14 patients who survived and were discharged in that group of 15 did not have any ischemie complications. Seventy-one of the patients had balloons inserted prior to aortocoronary bypass for impending infarction, unstable angina, left main stenosis with severe ischemia, or severe myocardial dysfunction. There were two hospital deaths in these 71 patients, and none of the survivors have had symptomatic arterial insuffi¬
ciency postoperatively. The two patients who had infection at the insertion site are interesting. The first patient had an overt, apparently superficial groin wound infection that apparently healed, and he was discharged from the hospital. He bled from the femoral arteriotomy site and the wound one month postoperatively, requiring repair of the femoral artery. Now, three years later, he is asymptomatic. The other patient had the sleeve graft replaced with a vein patch in the face of persistent bacteremia. The bacteremia cleared up and the patient is well. In our present practice, we heparinize our patients before insertion of the balloon and, insofar as possible, continue infusion of heparin until removal of the balloon. The insertion of the balloon should be gentle, with timidity considered to be a surgical
virtue under the circumstances. Arteriography is helpful in certain patients to demonstrate which side the iliofemoral lumen is best. Certainly, we agree with Dr Alpert that intra-aortic balloon pumping is life-saving, that it may have serious complications, and that our job is to prevent these complications insofar as possi¬ ble. George Kaiser, MD, St Louis: I think Dr Alpert has brought up the most common complication of intra-aortic balloon pumping. Our experience would tend to support this. We recently reviewed our series of 99 patients treated with intra-aortic balloon pumping. The greatest number of complications are associated with the site of insertion. These have not caused any significant difficulties in management. They have been relatively easily managed by local procedures. We have not used crossover grafts. There have been occasional instances in which we have had to do minor revisions at the arteriostomy site. If the patient has been perfused through a transverse femoral arteriotomy, it is more difficult to suture a graft. We would prefer to use a vertical arteriotomy. If one is unable to insert the balloon from below, it can be inserted through the aortic arch. This has been done successfully by my associate, H. B. Barner. He attached a long graft and then removed the intra-aortic balloon a few days later under local anesthesia, without having to do a thoracotomy.
I would draw your attention to two of our patients who had unexplained peroneal palsy. These patients had good peripheral pulses with the intra-aortic balloon in place and good pulses following this. This did not appear to arise from arterial insuffi¬ ciency. Both of these patients had resolution with supportive therapy. We are somewhat at a loss to totally explain this. I would ask Dr Alpert if he has seen this problem and whether he has any thoughts as to its cause. Hooshang Bolooki, MD, Miami: Dr Alpert has brought up an important subject, especially for that group who are using intraaortic balloon pump frequently. Our experience in Miami is with 157 patients who had intra-aortic balloon pumping. Ninety patients, or 57%, were long-term survivors, although 120 (76%) lived for longer than five days. Vascular complications occurred in nine patients. Two had claudication without arterial obstruction. We have had two limbs lost, one of them in a patient with cardiogenic shock and the other in a patient who required emer¬ gency intra-aortic balloon pump after surgery. I must say in both cases the reason for limb loss was low blood flow distally due to low cardiac output, and there was no way we could prevent that. Probably in these patients and five others who required femoral thrombectomy, a crossover graft would have been helpful. Other¬ wise, we don't really think in all balloon pump patients such a procedure should be done. Dr Alpert: It becomes apparent that as these gentlemen report their complications, the occurrence rate is also more than that reported in the literature. In a review of over 1,000 cases of intraaortic balloon pumping, no more than 25 complications were reported-roughly 4%. Drs Rainer, Patón, and Javid give a compli¬ cation rate (just with quick figuring) of approximately 30% to 33% on patients who survived. None of the discussants made mention of the number of balloons that had to be removed because of ischemia, or had to be transferred to the contralateral limb. We include these in our definition of "complication." Dr Kaiser, I certainly agree with you. We had six patients who had some degree of anterior compartment syndrome, three of whom required a fasciotomy. We believe that this is due to late recognition of those patients with distal thrombotic occlusive complications. Consequently, the plea for the use of the Doppler and frequent monitoring, virtually every four hours.
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