Frequency of long-term lower limb ischemia associated with intraaortic balloon pump use

Frequency of Long-Term Lower Limb lschemia Associated with lntraaortic Balloon Pump Use Marjorie Funk, PhD, RN, CCRN, Catherine F. Ford, MSN, RN, Doris W. Foell, MSN, RN, Susan Bonini, MSN, RN, Dorothy L. Sexton, EdD, RN, Adrian M. Ostfeld, MD, and Henry S. Cabin, MD

Lower limb ischemia is a frequent complication of intraaortit balloon pump (IABP) use. The incidence and risk factors for acute ischemia have been well-deftned, but little is known about longterm ischemk complications. This prospective study evaluated the incidence, nature, progression and predisposing factors for long-term lower limb ischemia in 151 patients who were previously treated with the IABP. These persons were interviewed and their lower extremities examined 12 to 20 months after undergoing IABP counterpulsation. Limb ischemia, characterized primarily by ipsilateral discomfort and diminished pulses, occurred in 18% of those evaluated. Evidence of ischemia worsened over time in 14%. Logistic regression analysis, which was based on variables found to be significant in bivariate analysis, revealed that the occurrence of limb ischemia acutely, cardiogenic shock as an indication for IABP insertion, and smoking (at the time of hospitalization or having quit
ince its introduction into clinical practice in 1967,’ the intraaortic balloon pump (IABP) has been used with increasing frequency and successin the managementof unstable angina and cardiogenic shock, and prophylactically before cardiac surgery. The most common complication associated with this device is acute ischemia of the limb into which the IABP catheter is inserted. It has beencited as occurring in 0 to 42% of patients undergoing IABP counterpulsation, with most investigators reporting a 10 to 20% incidence.2-25 In a prospective evaluation of 249 consecutive patients undergoing IABP counterpulsation over a 16month period at Yale-New Haven Hospital, we found that 47% had evidence of acute lower limb ischemia. Logistic regression analysis revealed that a history of peripheral vascular disease, female sex, and diabetes predisposed patients to the development of acute ischemic complications.26 Although the incidence and risk factors for acute lower limb ischemia have been established, little is known about the long-term effect of the IABP on the circulation of the lower extremities. The limited data available on the long-term consequencesof the IABP,6,10,15*27,28 along with the high rate of acute ischemic complications that we found, prompted us to evaluate these patients over time. The purpose of this prospective study was to determine the incidence, nature, progression and risk factors for long-term lower limb ischemia in patients who were previously treated with the IABP.

S

MetHODS

Patkn& Of the 249 patients in our initial study, 151 were available for long-term evaluation. Sixty-one of the original patients (24%) died during hospitalization. Of the 188 who were discharged, 16 subsequently died, 13 were lost to follow-up, 6 declined further participation in the study, and 2 had had thoracic instead of femoral insertions. Patients with acute limb ischemia were not excluded from long-term evaluation. The sampleof 151 consistedof 69% men (mean age f SD 65 f 10 years [range 36 to 861). Coronary insufficiency, which included acute myocardial infarction and unstable angina, was the most common indication From The Medical-Surgical Nursing Program, Yale University School for IABP insertion (80%). Cardiogenic shock, unsucof Nursing, New Haven, Connecticut. This study was supported in cessful angioplasty, and inability to wean from cardiopart by Datascope Corporation, Montvale, New Jersey; MedaSonics, pulmonary bypass prompted IABP use in most of the Mountain View, California, and Sigma Theta Tau-Delta Mu Chapter. remaining patients. Nearly all balloon catheters were Manuscript received February 20, 1992; revised manuscript received placed percutaneously, and most were 10.5Fr catheters and acceptedJune 30.1992. Address for reprints: Marjorie Funk, PhD, RN, CCRN, Medical- (DatascopcCorporation, Montvale, New Jersey). DuraSurgical Nursing Program, Yale University Schoolof Nursing, 25 Park tion of counterpulsation ranged from
119s

limb ischemia, the IABP was usually removed, and if ischemia persisted, a vascular surgical procedure was performed proeeckwe:Four of us (MF, CF, DF, and SB) and 3 researchassistantsevaluated subjectsin their homesfor evidence of long-term lower limb ischemia at 12 to 20 months after treatment with the IABP. We interviewed subjectsconcerning their current health and activity level, and asked about symptoms of lower limb ischemia, including pain, discomfort and sensorychanges. This was followed by an examination of the lower extremities for signs of &hernia. We evaluated skin color and temperature, trophic changesand the presenceof edema. Capillary refill was designated as “brisk” or “slow.” Popliteal, posterior tibial, and dorsalis pedis pulses were palpated and rated on a 4-point scale. If they were absent on palpation, a Doppler ultrasound probe was used. An anklebrachial index provided a standardized measure of pressures.Using a sphygmomanometer and Doppler probe, bilateral ankle and brachial pressures were measured. A ratio of the ankle pressure to the brachial pressureof <0.75 was considered abnormal. Interrater agreementon physical examination findings among the evaluators was 0.94. Lower limb ischemia associatedwith IABP use was defined as the presence of ischemic symptoms or abnormal physical findings on examination, or both, confined to the limb into which the balloon catheter had been inserted. Although contralateral ischemia might have been related to embolic or thrombotic phenomena causedor exacerbatedby the catheter, we believed that it was more likely due to prior underlying vascular diiease. StatIstkal anaIysIs: Frequencies were computed to define the incidence, nature and progression of lower limb ischemia. Preliminary bivariate analysis using chisquare and t teats was used to determine factors that were related individually (p <0.05) to the occurrence of ischemic complications. Stepwise logistic regression analysis was then usedto determine a group of variables that were related independently to the development of ischemia. In an effort to avoid missing any potentially important factors, all variables with a p value
THE AMERICAN JOURNAL OF CARDIOLOGY VOLUME 70

sample.Limb ischemia was also characterized by an ankle-bra&al pressure ratio of <0.75 in 5%, edema in 2%, postural color changesin 2%, and trophic changes in 1%.Additional subjectsexhibited signsof ischemia in both lower extremities. When questioned about ischemic symptoms, 11% complained of discomfort exclusively in the leg into which the balloon catheter had been inserted. This discomfort ranged from leg fatigue with exerciseto intermittent claudication to pain at rest. Sensory changes, which included numbness,tingling and a cold feeling, were present in the catheterized limb in 8% of patients. Again, a number of other patients had symptoms in both limbs. Almost one third of the sample noted some limitation in activity, with half of these limited by leg problems. Eleven percent sought physician evaluation for problems with circulation in their legs. w of lower limb ischemia: To determine the progressionof lower limb ischemia over time, objective signsof ischemia were comparedwith signsof problems documented by us during hospitalization, and patients were asked to compare symptoms of ischemia from the time of hospital dischargeto the present.Signs and symptoms of ischemia in the catheterized limb worsenedover time in 14%. Bilateral progressionof ischemia occurred in an additional 15%.Furthermore, 5% of those who had no evidence of balloon-related ischemia acutely, had problems at follow-up; 18% of those with minor ischemia in the hospital becameworse, and 38% of those with major ischemic complications acutely were worse at follow-up evaluation. A major ischemic complication was defined as an acute vascular condition that resulted in a residual deficit, caused restriction of activity or prolonged hospitalization, or required intervention. Risk factors for long-term lower limb ischeda: Bivariate analysis revealed that, of the 19 variables analyzed (seeTable I), acute lower limb ischemia, smoking (defined as smoking at the time of hospitalization or having quit
CABLE I Relation of Variables to Chronic Lower Limb lschemia myBivariate Analysis

Variable Sex Men Women Acute limb ischemia Yes No Hypertension Yes No Preexisting symptomatic PVD Yes No Smoking Current or quit < 10 years ago Never or quit t 10 years ago Diabetes Yes

No Hypercholesterolemiat Yes

No Cardiac index during or after IABP counterpulsationt <2 liters/min/m2 Always r2 liters/ min/m2 Mean arterial pressure during or after IABP counterpulsation <70mmHg Always 2 70 mm Hg Systemic vascular resistance during or after IABP counterpulsationt z 1,300 dynes s cm-5 Always 5 1,300 dynes s cm-5 Restraint used on leg with IABP catheter Yes

No Vasopressors during or after IABP counterpulsation Yes No Cardiogenic shock as indication for IABP counterpulsation Yes No Saphenous vein graft from same leg as IABP catheter Yes No IABP catheter inserted with aid of fluorosCOPY Yes No

Total No. of Patients

No. (%I of Patients with Limb lschemia

104

16 (15.4%)

47

11 (23.4%)

71 80

23 (32.4%) 4 (5.0%)

o.ooo*

77 74

16 (20.8%) 11 (14.9%)

0.462

48 103

14 (29.2%) 13 (12.6%)

0.025*

68

18 (26.5%)

0.023*

83

9 (10.8%)

TABLE I

Continued

Variable

p Value 0.336

Total No. of Patients

No. (%I of Patients with Limb lschemia

119 30

21 (17.6%) 5 (16.7%)

0.887

14 137

4 (28.6%) 23 (16.8%)

0.466

112 37

22 (19.6%) 4 (10.8%)

0.328

Physician inserting IABP cathetert Cardiologist Cardiothoracic surgeon Difficulty inserting IABP catheter Yes No Diameter of IABP cathetert 10.5Fr 12.OFr

Age

p Value

Mean (SD) for Patients With Limb lschemia

Mean (SD) for Patients Without Limb lschemia

p Value

66.7 (9.91

64.1 (10.4)

0.231

*p <0.05. tincomplete data. IABP = lntraaortic balloon pump; PVO = peripheral vascular disease 41 110

8 (19.5%) 19 (17.3%)

0.936

68 73

10 (14.7%) 15 (20.5%)

0.492

TABLE II Odds Ratios of Variables Found to be Significantly Related to Chronic Lower Limb lschemia by Bivariate Analysis % with lschemia

Variable 32 101

9 (28.1%) 14 (13.9%)

0.112

70 81

18 (25.7%) 9 (11.1%)

0.034*

43 50

8 (18.6%) 6 (12.0%)

0.550

39 112

7 (17.9%) 20 (17.9%)

0.818

65 86

15 (23.1%) 12 (14.0%)

0.217

15 136

6 (40.0%) 21 (15.4%)

0.045*

40 80

7 (17.5%) 12 (15.0%)

0.930

123 28

21 (17.1%) 6 (21.4%)

0.787

Acute limb ischemia Yes No Preexisting symptomatic PVD Yes No Smoking Current or quit < 10 years ago Never or quit s 10 years ago Cardiogenic shock as indication for IABP counterpulsation Yes No Mean arterial pressure during or after IABP counterpulsation <70mmHg Always 2 70 mm Hg

p Value

Odds Ratio (95% Cl)

32.4% 5.0%

0.000

9.10 (2.97,27.951

29.2% 12.6%

0.025

2.85 (1.22,6.68)

26.5% 10.8%

0.023

2.96 (1.23, 7.11)

40.0% 15.4%

0.045

3.65 (1.18, 11.34)

25.7% 11.1%

0.034

2.77 (1.15, 6.65)

Cl = confidence interval; IABP = intraaortic balloon pump; PVD = peripheral vasculardlsease.

Those who had had their IABP inserted for cardiogenic shock were 3.59 times as likely as those who had other indications for IABP counterpulsation to have ischemia (95% confidence interval 1.01 to 12.75). Smokers were 2.87 times more likely than nonsmokersto have ischemia (95% confidence interval 1.10 to 7.46). MSCUSSION

Much is known about acute ischemic complications associatedwith IABP counterpulsation, but there are only a few reports6JoJ5~27~28 evaluating the long-term consequencesof the IABP. These reflect use of the IABP >lO years ago. Since then, the technology has changed (including use of the percutaneous approach and portable IABP systems) and indications for use ISCHEMIA AND BALLOON PUMP

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TABLE III Adjusted Odds Ratios of Variables Found to be Significantly Related to Chronic Lower Limb lschemia by Multivariate Analysis Vanable Acute limb ischemia (0 = no, 1 = yes) Cardiogenlc shock (0 = no, 1 = yes) Smoking(0 = no, 1 = yes) Intercept

Standard Error

Adjusted Odds Ratio (95% Cl)

2.1851

0.5890

8.89 (2.80, 28.21)

1.2768

0.6475

3.59 (1.01,

12.75)

1.0541 3.6831

0.4877 0.6357

2.87 (1.10,

7.46)

Beta

Cl = confldence interval.

have expanded. More patients are being treated with the IABP, and more are surviving their acute event and resuming active lives. It is important, therefore, to appreciate the long-term effect of this device. We evaluated signs and symptoms of lower limb ischemia in 151 patients who had undergone IABP counterpulsation 12 to 20 months previously. Ipsilateral lower limb ischemia was evident in 18%.This is lower than the ischemic rates of 26 to 32% reported by other investigators.6,10**5~27 The more conservative definition of ischemia used in our study may account for the lower rate. Ischemia had to be present exclusively in the limb into which the balloon catheter had been inserted for it to be considered associatedwith IABP use. An additional 19% of our patients had bilateral ischemic problems. It is not clear from reports of other studies whether bilateral ischemia was attributed to the IABP catheter. If so, their rates of ischemia may be falsely high. However, improvements in the design of the balloon catheter or increasedskill of the physicians inserting the catheter may have led to the lower complication rates in our series. Nonetheless, the fact that 18% of the sub jects we assessedhad evidence of lower limb ischemia directly attributable to IABP use is notable. We also found that evidenceof ischemia in the catheterized limb worsenedover time in 140/o,and that those with more serious problems acutely had greater deterioration. We evaluated patients at 12 to 20 months after they had undergone IABP counterpulsation. It is not known whether continued longitudinal follow-up would have revealed persistent progressionof problems, Other investigators did not indicate that they evaluated the course of limb ischemia. Becauselimb &hernia remains a problem long after use of the IABP, and actually gets worse in some patients, it is important to determine risk factors for this complication. Multivariate analysis revealedthat the occurrence of acute ischemic problems, cardiogenic shock as the indication for IABP use, and smoking predisposed patients to long-term limb ischemia. The peripheral hypoperfusion resulting from cardiogenic shock, in the setting of thrombus formation associatedwith vascular trauma related to the balloon catheter, may contribute to placing these personsat heightened risk. It is notable that smoking emerged as an independent predictor of leg ischemia, while preexisting symptomatic peripheral vascular diseasedid not. Smoking is a known risk factor for vascular disease,and may, in fact, be a 1199

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more sensitive marker for underlying disease than is claudication. It is plausible that many patients without claudication had subclinical peripheral vascular disease, which then predisposed them to long-term ischemic problems. We,26as well as others,3,4,s,29 found that preexisting peripheral vascular diseasewas associatedwith acute ischemic complications. The initial phase of our study also revealedthat smoking was significantly related to the occurrenceof major acute ischemic complications.26 Only 1 previous study evaluated predisposingfactors to long-term problems.6They determined that difficulty inserting the balloon catheter was the only factor associated with ischemic complications; we did not find this to increase risk significantly (p = 0.466). Our observation that detrimental effects of IABP counterpulsation persist after hospitalization emphasizes the necessityof ongoing vascular assessments,especially in patients whose history of acute limb ischemia, cardiogenic shock or smoking places them at increasedrisk. Acknowledgmenk We are very grateful to Patricia Bresser, MSN, RN, Ina Olsson, BSN, RN, and Prasama Sangkachand,MSN, RN, CCRN, for their assistance with data collection. We also thank Jane Dixon, PhD, and Antionette Tyndall, MSN, RN, CCRN, for their valuable comments regarding this study.

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