1 7i

Percutaneous Transluminal Angioplasty of the Infrapopliteal Arteries: Results in 53 Patients

Curtis W. Bakal1 Seymour Sprayregen1

Karen SCheinbaurn1

Jacob
Frank

Cynarnon1
J.

Veith2

Recent reports suggest that percutaneous transluminal angioplasty is a satisfactory alternative to surgical treatment of occlusion of the infrapopliteal arteries. To evaluate further the merits of percutaneous angioplasty of these vessels, we retrospectively analyzed the results of 57 procedures in 53 patients. Seventy-six infrapopliteal arteries were dilated: 26 anterior tibial arteries, 10 posterior tibial arteries, 18 peroneal arteries, and 22 tibioperoneal trunks. Thirty-three (62%) of the patients had concomitant angioplasties of the femoropopliteal arteries or vein grafts. There were three major complications (one death due to cardiac arrest 5 hr after the procedure and two puncture-site hematomas requiring surgery). Twenty minor complications did not affect clinical course. In the first 14 procedures (25%), tapered catheters were used, and technical success occurred in only four (29%). In the succeeding 43 procedures (75%), Gruentzig balloon catheters and low-profile balloons were used, and technical success occurred in 37 procedures (86%). Prompt clinical improvement was seen in 32 (80%) of 40 technically successful procedures. Prompt clinical improvement occurred in 28 (97%) of 29 prosedures in which angioplasty restored straight-line flow to the foot (i.e., nonobstructed blood flow in at least one calf vessel that is narrowed by no more than 75% of its diameter). When such flow was not restored, clinical improvement occurred in only four (36%) of 11 cases (p < .001). These results show that with current technology, infrapopliteal artery angioplasty is an effective and safe procedure. The greatest benefit is achieved when straight-line blood flow to the foot is restored.
AJR 154:171-174, January 1990

Received June 9, 1989; accepted

August 30, 1989.

after revision

Presented in part at the annual meeting of the American Roentgen Ray Society, San Francisco, CA, May 1988.
1

Despite the fact that Dotter and Judkins [i ] described three cases of angioplasty of the tibioperoneal trunk in their classic paper on transluminal angioplasty in i964, experience in dilatation of the calf vessels has been limited. To date, only a few reports describe the use of angioplasty in the infrapopliteal arteries. Early series in which tapered catheters were used for dilatation had mixed results [2, 3]. Only two papers on infrapopliteal artery angioplasty have been published since low-profile balloons and steerable guidewires have been available, and these suggest that the success of angioplasty has increased with the advent of these new technologies [4-6]. We report our results in 53 patients who were treated primarily for limbthreatening ischernia, and we analyze some of the technical and anatomic factors that influenced the outcome of the procedures.

Department St.,

of Radiology, Bronx, of

Montefiore

Medical

Center and Albert Einstein

E. 21 0th
2

College NV 1 0467.

of Medicine, 111 Address reprint Medical 111

Subjects

and Methods

requests to C. W. Bakal.
Department and Albert Surgery, Montefiore Center Einstein College of Medicine,

E. 210th St., Bronx, NV 10467. 0361-803X/90/1541-0171 American Roentgen Ray Society

We analyzed the results of 57 percutaneous transluminal angioplasties of the infrapopliteal arteries performed in 53 patients at our institution between 1 979 and 1 987. Four of these patients underwent a second angioplasty during this time period. The patients ranged in age from 36 to 96 years, with a median of 70 years. Thirty (57%) were men, and 23 (43%) were women. Forty-five (85%) of the patients were diabetic, and 25 (47%) were smokers. Thirtyfive patients (66%) had known coronary artery disease.

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ET

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AJR:154,

January 1990

Fifty-six of the 57 procedures were performed for limb salvage, which was necessary if pain while at rest, nonhealing minor amputation cases tient sites, ulcers, infection, 1 0 patients graft. or gangrene were present. Limb-salvage included with

TABLE 1: Infrapopliteal Beneficial Early Clinical

Angioplasty: Response

Technical

Success

and

extremities.

with failing bypass grafts and symptomatic One procedure was performed in an asymptomatic pa-

Good
Procedure

Clinical

Technical
Success

Response
Technical Success

After

a failing

Overall Good Clinical Response

All patients received aspirin (325 mg) the evening before the procedure and were maintained on aspirin and dipyridamole (150 mg/ day) after the procedure. Diagnostic arteriography was generally

performed
diagnostic dipine

24-72
study was

hr before
immediately administered

angioplasty,
preceded immediately

but in a few cases

angioplasty. before Sublingual the procedure.

the
nife-

Catheter only (n 1 4) Balloon (n = 43) Total (n = 57)

a
b

4/1 4 (29%)8 37/43 (86%)a 41/57 (72%)

4/4 28/36
32/40

(1 00%) (78%)b
(80%)

4/i

4 (29%)

28/42
32/56

(67%)
(57%)

(10 mg)

All angioplasties

mon femoral
the superficial

were or superficial
femoral

performed via an ipsilateral antegrade cornfemoral artery approach. After catheterizing

but before crossing the target lesions,

in technical success rates is significant (p < .05). One patient died 5 hr after successful angioplasty and is excluded Difference

from

clinical

response data.

artery,

8000 units of intraarterial heparin was given; supplemental heparin was administered if the procedure was prolonged. Heparin was usually neutralized by IV administration of protamine at the end of the procedure. Seventy-six infrapopliteal arteries were dilated: 26 anterior tibial arteries, 1 0 posterior tibial arteries, 18 peroneal arteries, and 22 tibioperoneal trunks. Thirteen patients underwent angioplasty of two

Technical

Success
(78%)

of these vessels,

and three patients

underwent

angioplasty

of three

of these vessels. Thirty concomitant femoropopliteal artery angioplasties were performed successfully. Twelve patients had infrainguinal venous bypass grafts in place at the time of angioplasty; concomitant angioplasty was successful in the three grafts in which
dilatation The first catheters was (Cook, attempted.

were performed with tapered angiographic Bloomington, IN). Beginning in 1981 , 4-mm Gruentzig-type angioplasty balloons (Medi-tech, Watertown, MA) were used, sometimes in combination with tapered catheters, for the next 19

1 4 procedures

cases.
balloons

In late 1985, we began using 3-mm and smaller low-profile

(Advanced (0.41 mm) was Cardiovascular steerable used most often Systems, in the last Temecula,
24

CA)

with

0.01 6-in.
this

guidewires

(USCI-Bard,

Billerica,
cases.

MA);

technology

Angiograms and hospital charts were analyzed retrospectively. All patients were monitored until hospital discharge or 1 month after angioplasty, whichever came first. When available, follow-up noninvasive flow and pressure studies (30 patients) and angiograrns (four patients) were used to evaluate the response to angioplasty. Single short lesions were defined as stenoses less than 1 cm in length; long or multiple lesions were defined as single lesions longer than 1 cm or sequential lesions. The term straight-line flow is used to indicate nonobstructed flow to the foot via at least one calf vessel which is narrowed by no more than 75% of its diameter. Technical success was defined as dilatation yielding restoration of 75% of vessel lumen diameter. A beneficial early clinical response was defined as healing of lower extremity lesions or amputation sites, or clearing of signs and symptoms such as infection or rest pain. Responding patients all had restoration of distal pulses and/or improvement in noninvasive laboratory parameters. Major complications were defined as those that prolonged hospital stay, affected treatment significantly and adversely, or yielded a residual deficit. Complications were considered minor if they did not affect clinical course. Data were analyzed by chi-square analysis or the Fisher exact test, where appropriate [7, 8], and statistical significance was defined byp<.05.

Fifty-nine of 76 vessels were dilated successfully. Successful dilatation was achieved with catheters in 5 (33%) of i5 vessels and with balloons in 54 (89%) of 6i . Two (40%) of five occlusions were dilated successfully; all occlusions occurred in the group treated with catheters. Vessels were dilated successfully in 1 7 (89%) of i 9 angioplasties performed with (4 mm) Gruentzig balloons; 20(83%) of 24 angioplasties performed with (3 mm and smaller) lowprofile balloons were successful. By using balloons, 47 (92%) of 51 vessels with nonosteal lesions were dilated successfully, compared with seven (70%) of iO vessels with osteal lesions (p = .068, NS). Nine of 10 osteal lesions occurred in the anterior tibial artery. Osteal lesions accounted for half of all technicalfailures with balloons; the single failure to dilate a short-segment lesion occurred at the anterior tibial artery origin. Technical failure was usually due to unresponsiveness of the vessel with the lesion to dilatation; inability to cross the lesion was an infrequent cause of failure. In one case, a technical failure occurred when a low-profile coronary balloon failed to pass through a stenosis. It was thought that a low-profile angiographic balloon, which has more shaft stiffness than its coronary analog, probably would have passed if it had been available to us at that time. By using balloons, successful dilatation was achieved in 16 (73%) of 22 anterior tibial arteries and in 38 (97%) of 39 other vessels (p < .01). With osteal lesions excluded, technical success occurred in i 0 (77%) of i 3 anterior tibial arteries and in 37 (97%) of 38 other vessels (p < .05). Technical success was achieved in 27 (96%) of 28 single short lesions and in 27 (84%) of 32 long or multiple lesions (p = .1 1).

Beneficial

Early

Clinical (97%)

Response of the 29 patients

flow

Results
The shown technical in Table

success 1 . Other

and

clinical

response

rates

are

factors

influencing

success

are

described next.

angioplasty showed a clinical response. In 27 of these patients, straight-line flow was restored in only one calf artery. When straight-line flow was not restored, only four (36%) of 1 1 patients responded clinically (p < .001). A clinical response occurred in 1 0 (91%) of i 1 peroneal artery angioplasties and in eight (1 00%) of eight anterior or posterior tibial artery angioplasties in which straight-line flow was restored. Twenty-six (96%) of 27 diabetic patients, two (1 00%) of two nondiabetic patients, and
successfully restored straight-line to the foot

Twenty-eight

in whom

AJR:154,

January

1990

PTA

OF

INFRAPOPLITEAL

ARTERIES

173

21 (91 %) of 23 patients with ischemic tissue loss responded to restoration of straight-line flow. Four patients with technically successful angioplasties underwent a second procedure 2-8V2 months later; two patients showed a good clinical response to the second dilatation.

Complications There were three major complications. Two large puncture-

site hematomas required surgical repair; one of these patients had been heparinized soon after the procedure by the surgical staff. A third patient died suddenly 5 hr after angioplasty, presumably from a cardiopulmonary arrest. Twelve hours after angioplasty, a fourth patient with chronic renal failure sustained a cardiopulmonary arrest from iatrogenic hyperkalemia unrelated to the procedure. The patient was resuscitated but was left with a mild neurologic deficit. Eighteen patients had 20 minor complications. There were six vessel occlusions in six patients, five occurring after multiple or long-segment dilatations. Transcatheter aspiration of an embolus to a severely diseased nontarget artery was successful in the one case in which it was attempted. Three emboli occurred proximal to more distal occlusions in target or nontarget arteries. Two emboli were noted in severely stenotic pedal artery branches; both of these patients improved after angioplasty. There were nine small groin hematomas. Two cases oflocalized contrast extravasation resulted from arterial perforation from a guidewire and catheter; both healed spontaneously. Three patients experienced transient acute renal failure; two of these had a history of chronic renal insufficiency. No limbs were lost or acutely deteriorated from an angioplasty complication, and in no case did a complication require emergent surgical revascularization.

Discussion
Our primary technical success rate increased approximately threefold after we began using balloons instead of tapered catheters. Our technical success rate was significantly higher in the tibioperoneal trunk, posterior tibial artery, and peroneal artery than it was in the anterior tibial artery. Technical success was higher in patients with single short or nonosteal lesions, though the difference was not statistically significant. Restoration of nonobstructed flow to the foot was a highly significant factor in predicting a beneficial clinical response in
all

patients.

Restoring

straight-line

flow

via

any

one

of the

arteries appears sufficient for a clinical response. Most of the patients who underwent proximal tibial or peroneal angioplasty of vessels that were occluded distally were considered either extremely poor surgical risks because of their underlying medical condition or were deemed to have anatomy inadequate for distal bypass surgery. In these patients with poor distal runoff, amputation was usually believed to be the only alternative to angioplasty; it was hoped that their limbs could be salvaged by increasing flow to collaterals proximal to distal occlusions. The concept of increasing flow into noncontinuous tibial arteries was as yet untested, beinfrapopliteal

cause there had been no large series of infrapopliteal angioplasties published before this study. On analyzing these data, we conclude that infrapopliteal artery angioplasty will almost always yield beneficial clinical results when nonobstructed flow to the foot is restored, but angioplasty will yield a response in only about one third of cases in the presence of obstruction distal to the dilatation site. In no case did an angioplasty complication preclude bypass surgery that the original vascular anatomy would have permitted. One death occurred in this series, yielding a periprocedural mortality rate of 1 .8%. By comparison, the operative mortality rate for patients undergoing small vessel bypass at Montefiore Medical Center is 2.9%; for those undergoing primary amputation (probably the sickest group) it is 1 1 % [9]. Arterial spasm was not encountered. Most of our patients received sublingual nifedipine immediately before angioplasty. We do not administer transcatheter nitroglycerin prophylactically. In some early series of popliteal angioplasties performed primarily with van Andel catheters, spasm was reported in 244% of cases [2, 3, 10] and often led to thrombosis. More recently, other workers have similarly remarked on the presence of spasm [4, 6]. We cannot explain the discrepancy in the incidence of spasm between our series and those of others, but we note that Brown et al. [5] also did not use nitroglycerin and had a low incidence of spasm. There is also disagreement in the literature regarding heparinization after tibial vessel angioplasty. We have not routinely heparinized our patients after angioplasty and have had no acute thromboses. One of our patients was treated with heparin by the vascular surgeons 8 hr after angioplasty; that patient showed signs of femoral nerve compression from a puncture-site hematoma and had surgery to repair it. The reported experience with infrapopliteal artery angioplasty is limited but expanding. Two early papers dealing with small numbers of patients, with angioplasty performed primanly with tapered catheters, reported mixed but promising results [2, 3]. Soon after, Starck et al. [1 0] described 49 infrapopliteal angioplasties performed with 5- to 7-French van Andel catheters, which were part of a larger group of 149 popliteal and infrapopliteal angioplasties. These authors reported a 76% technical success rate and an 88% clinical response rate in patients monitored until discharge. To our knowledge, there have been only two other series on infrapopliteal angioplasty since the advent of angioplasty balloons. In these papers, all procedures were performed with low-profile balloons and steerable guidewires [4, 5]. Schwarten and Cutliff [4} dilated 1 45 arteries in 98 patients and reported a primary anatomic success rate of 97% with initial healing in 88%. Differences in selection of patients and anatomy probably exist between that population and ours; for example, only 60% of Schwartens patients were diabetic. Brown et al. [5] reported a 75% technical success rate in 11 patients, 89% of whom were diabetic, and an 89% early response to successful angioplasty. These two papers did not analyze specific factors that influenced technical success or clinical response. However, five of six patients in Browns series who had prolonged clinical success had palpable distal pulses after angioplasty, suggesting the importance of restoring continuity of flow to the foot.

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Schwarten and Cutliff [4] reported a 2% major complication rate. Brown et al. [5] reported two thromboses in 1 1 patients, possibly a result of their patients having received only 3000 units of heparin during the procedure. We feel, as do others [6], that liberal use of systemic heparin during angioplasty of peripheral vessels is probably more crucial than its use in angioplasty of higher flow vessels, such as the iliac arteries. It is becoming clear that technical advances and increased experience are yielding excellent results in treating lesions of the arteries below the knee [6], which were formerly considered inaccessible to and unsafe for angioplasty. Although the long-term efficacy still needs to be evaluated, the results of infrapopliteal artery angioplasty appear to approach those of distal bypass surgery, with less morbidity and mortality.
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DE, Cutliff WB. Arterial occlusive

disease

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6. Casarella WJ. Percutaneous transluminal angioplasty below the knee: new techniques, excellent results. Radiology 1988;1 69:271-272 7. Siegel S. Nonparametric statistics for the behavioral sciences. New Vork:
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Intervent