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Balloon angioplasty with intraluminal stenting as the initial treatment modality in Aorto-Iliac occlusive disease
Balloon Angioplasty With Intraluminal Stenting as the Initial Treatment Modality in Aorto-Hiac Occlusive Disease James B. Williams, MD, FACS, Paul W. Watts, BS, Vu A. Nguyen, Cynthia L. Peterson, Abilene, Texas
PURPOSE: We retrospectively evaluated balloon angioplasty with intraluminal stenting to define applicability, early results, cost, and length of stay. METHODS: Seventy-three patients underwent 9 4 aorto-iliac angioplasties with intraluminal stents from October 1 9 9 1 through July 1 9 9 3 . All had disabling claudication or rest ischemia.
stenting in all patients presenting with atherosclerotic oc clusive disease of the iliac arteries who require treatmenl
PATIENTS AND METHODS From October 1991 through July 1993, 83 patients un dergoing 104 procedures presented for treatment of symp tomatic aorto-iliac occlusive disease. All patients who pre RESULTS: Mean follow-up was 10.2 months and sented for treatment of aorto-iliac disease were initiail, attempted to be treated by balloon angioplasty with intra was 90.4% complete. Ninety percent of procedures were immediately successful. T h e r e were no luminal stenting. The procedure was considered a failur~ deaths within 3 0 days of surgery. Complications in 10 patients (10 procedures) due to the inability to cros , occurred in 1 3 % . The anlde:brachial indices imlesions, leaving 73 patients (47 men, 26 women) under proved in all groups. Functional class improved in going 94 iliac balloon angioplasties with implantation o an groups. In class 4, limb salvage o r a benefit on intraluminal stents who comprise the study group for thi level of amputation was universal. Length o f stay report. The average age of patients was 68 years (range 4 ranged 33% to 82% less than when aorto-iliac or to 87). All patients were severely symptomatic with eithe aortofemoral bypass were undertaken (diagnosisdisabling claudication (45 patients) or rest ischemia (2: patients), Nineteen of 73 patients (26%) were diabetic, 6: related group 39.25). Hospital charges for stent procedures ranged 25% to 6 6 % less than for of 73 (89%) had history of cigarette smoking, 30 of 7. aorto-iliac or aortofemoral bypass (diagnosis-re(41%) had prior history of myocardial infarction or stroke and 42 of 73 (58%) had history of hypercholesterolemia lated group 39.25). CONCLUSION: T h e p r o c e d u r e is widely applicable, The procedure was considered a failure if lesions could no with an apparent initial advantage in mortality, be crossed with guidewires, if luminal patency could no morbidity, charges, and length of stay. Durability be restored or augmented, or if intraluminai stents couh is unproven. not be satisfactorily deployed. Simultaneous or subsequen distal reconstructive procedures were performed in 20 o ndoluminal treatment of atherosclerotic arterial occlu- 94 procedures (21%). Renal failure was defined by a 50~ sive disease of the aorto-iliac segment is theoretically rise in the serum creatinine level. Distal embolization oc appealing for its potential to reduce procedure-related mor- curred if the typical "trash foot" pattern or "blue toe" syn bidity, 30-day mortality, and hospital length of stay. 1 drome was observed postoperatively. All procedures wer, Although balloon angioplasty is generally reserved for dis- undertaken in a specially equipped endovascular suit, crete lesions, L2 its applicability and incidence of compli- (International Surgical Systems, Phoenix, Arizona) con cations when used in lesions of a more diffuse nature are sisting of a specially designed operating table witJ unknown, and restenosis remains a barrier to the durabil- roentgenographic equipment. The interventional suite wa ity of isolated balloon angioplasty. 3,4 Endoluminal stent- equipped with general anesthesia technology and con ing in conjunction with balloon angioplasty offers the pos- tained instrumentation for both endoluminai and standarq sibility of favorably altering the incidence of restenosis surgical procedures, which could be performed concomi seen with balloon angioplasty alone. 3 However, deploy- tantly if necessary. ment of multiple stents in areas of diffuse atherosclerosis For purposes of comparing hospital charges and hospi likewise is an undefined procedure.3 This retrospective re- tal length of stay, patients undergoing stent procedure view was conducted to direct further analysis into the ap- were divided into three groups: A (unilateral procedure~, plicability, early results, morbidity, mortality, and cost ef- 53 patients/53 procedures), B (bilateral procedures, sam fectiveness of balloon angioplasty with endoluminal setting, 9 patients/18 procedures), and C (bilateral proce dures, different settings, 11 patients/23 proceduresl Additionally, these groups were compared with diagnosis related group (DRG) procedure 39.25 (aorta-iliac-femor~ From the AbileneHeartand VascularInstitute,Abnlene,Texas. This studywas supportedin part by an educationalgrantfromJohnson bypass) and DRG procedure 39.29 (other peripheral vas & Johnson InterventionalSystemsCo., 35 TechnologyDrive, Warren, cular shunt or bypass) with regard to average hospit~ New Jersey. charges and length of stay during the same time frame Requests for reprintsshouldbe addressedto James B. Williams,MD, Functional class assessment preoperatively and postopex 1665 AntilleyRoad, Suite 250, Abilene,Texas79606. Presented at the 22nd Annual Meeting of the Society for Clinical atively is defined as follows: class 1--asyml~tomatic; clas Vascular Surgery,Tucson,Arizona,March2--6, 1994 2--symptoms with moderate activity; class 3--symptom
E
202
THE AMERICANJOURNALOF SURGERY® VOLUME168 AUGUST1994
BALLOON ANGIOPLASTYWITH INTRALUMINALSTENTING/NgllJJ'AMS'I?.T,,AL
with minimal activity, refractory to medical management; and class 4 symptoms at rest, motor or sensory loss, ischemic soft tissue changes. Each patient was given a corresponding numerical functional class value, so that average postoperative functional class could be calculated. All procedures were performed in patients under regional or general anesthesia, utilizing systemic heparinization. Heparin was reversed at the termination of the procedure o~ shortly afterward in the recovery area. No postoperatwe anticoagulation was employed. Follow-up consisted of direct patient examination by the ptlysican-author in routine follow-up visits, or by telep~lone interviews of patients, and was achieved in 66 t"0.4%) of patients. Follow-up ranged from 0 to 27 months ~th a mean of 10.9 months. ?reoperative ankle:brachial indices (ABI) were not avail,~le in many patients for the following reasons: (1) ur~,:ncy in limb salvage situations, which precluded their I ,:rformance; (2) accompaniment of outside studies (which ere not repeated) that did not contain ABI as part of the . ~sessment; and (3) performance of ABI was not neces, Lry to document the diagnosis of limb ischemia. Palmaz balloon expandable stents (P308, Johnson & ,~hnson Interventional Systems Co., Warren, New Jersey) ere employed exclusively. Meditech balloons catheters 8oston Scientific Co., Watertown, Massachusetts) of apt'opriate diameter and length were used, in addition to bal,on catheters on which some Palmaz stents were factory ~ounted. Sheaths were appropriate sizes and lengths manfactured by Cook (Cook Group Company, Bloomington, ~diana) or Meditech. Wires were either the Meditech ,lidewire or Wholey wire (Mallinckrodt Medical, Inc., St. ouis, Missouri) of a length of .035 inches. Percutaneous ' ocedures (36% or 38%) were performed using standard ,:ldinger technique. Contrast was Isovue 370 (Schmidt ~lagnostics, Bristol-Myers Squibb, Princeton, New ,'.rsey) diluted two parts contrast with one part normal Aine. Open procedures (58% or 62%) were performed ~a short cutdowns over the common femoral artery, or if dditionai distal procedures were anticipated, with a stanard femoral artery dissection. No intraoperative thromolysis of iliac segments as part of the operative procedure 'as performed. "{ESULTS There were no deaths within 30 days of the procedure. Complications occurred in 12 of 94 procedures (13%). "here were 6 superficial wound infections, 2 mispositioned .tents (none with clinical consequences), 1 common iliac :lrombosis, which responded to thrombolytic agents, 2 pa?ehts had cellulitis distal to the operative site, presumably !ue to ischemia at the time of presentation, and 1 case of ~rinary retention requiring transurethral resection of the ~rostate. There were no cases of postoperative renal fail~re, and no evidence of distal embolization was found. Endoluminal treatment was successful as the initial ~lodality in 73 of 83 patients (94 of 104 procedures) who )resented for treatment during the study period. Lesions ailing endoluminal therapy included 7 total iliac occlu..ions, 2 infrarenal aortic occlusions, and 1 retrograde ia~rogenic dissection. No failures were attributable to in-
TABLE I Changes in Ankle:Brachial Indices Total Group" Class 3" Preoperatively .650 .697 Postoperatively .737 .773 "Priorto or withoutsubsequentdistalprocedure.
Class 4" .475 .603
TABLE II Hospital Length of Stay and Charges Length of Stay (days) Charges ($) Group A 2.55 15,594 Group B 5.43 15,647 Group C 9.45 34,803 DRG39.25 14.10 46,253 DRG39.29 12.10 21,290
ability to access the artery, or, once the lesions were crossed, inability to dilate the artery or deploy the stent(s). All failures were due to inability to traverse the lesion with guidewires. A total of 44 angioplasties (47%) utilized 1 stent, 37 (39%) used 2 or 3 stents, and 13 (14%) used 4 or more stents. An average-of 2.1 stents were used per procedure (range 1 to 7). No technical successes required conversion to standard operative procedures, either acutely or during the follow-up period. Functional class improvement was assessed in those 85 procedures without or prior to distal reconstruction and improved for the group from an average of 3.38 preoperatively to 1.60 postoperatively (an improvement of 1.78 functional classes). Class 3 improved to 1.59 (an improvement of 1.41 functional classes), and class 4 improved to 1.62 (an improvement of 2.38 functional classes). ABI change in patients in whom both preoperative and postoperative ABIs were available were assessed prior to a distal procedure, if any (38 patients of 52 procedures), and are depicted in Table I. The effect on limb salvage was assessed for 28 patients in functional class 4. Two patients required amputation within 30 days (both digital). Five patients required amputations after 30 days (2 digital, 3 below the knee). Eight patients in class 4 required distal reconstructive procedures, 3 within 30 days of stenting, and 5 after 30 days from stenting. All patients requiring amputation presented with some irreversible ischemic skin or soft-tissue changes. A benefit in limb salvage or level of amputation was universal. Angiographically documented recurrence occurred in three patients during the study period; all recurrences were due to lesions in nonstented areas. The analysis of hospital length of stay and hospital charges is shown in Table H. COMMENTS Establishment of arterial inflow in cases of exercise or rest ischemia of the lower extremities caused totally or in part by aorto-iliac occlusive disease traditionally has been achieved in good risk patients by aortobifemoral bypass grafting (ABF), or in higher risk patients by femoro-
THE AMERICANJOURNALOF SURGERY* VOLUME168 AUGUST1994 2 0 3
BALLOON ANGIOPLASTY WITH INTRALUMINAL STENTING/WILLIAMS ET AL
femoral (CF) or axillobifemoral (AXBF) bypass grafting. Although these procedures are very effective (5 years patencies of 70% to 80%) and low risk (30 day mortalities of 1% or less for ABF, 2% to 5% for CF, AXBF), they are not performed without significant morbidity or hospital stay. 2 Less invasive procedures, receiving a great deal of attention in the cardiology and radiology literature, 5-s deserve consideration as to their role in this setting. Admittedly, this review is not a randomized prospective comparison of standard and nonstandard surgical techniques and has the usual shortcomings associated with retrospective analysis. Nonetheless, it does raise some worthwhile questions regarding mortality, morbidity, applicability, cost, and hospital length of stay associated with endoluminal therapy. Despite multiple risk factors and advanced age in these patients, hospital mortality was zero. This may be attributable to a lower physiologic stress associated with this procedure. Complications were low in number and were, for the most part, not of a life-threatening nature. Adequate hydration and the use of dilute contrast contributed to the absence of postoperative renal failure. Although the use of preoperative and intraoperative thrombolytic agents might increase the technical success rate, it also might contribute to the absence of distal embolization noted in this patient population. The mispositioned stents occurred early in the physician-author's experience and had no adverse clinical consequences. They were managed by deployment, not retrieval. Technical success was high. Failures occurred most often with chronic occlusion. Despite a large number of patients with diffuse disease, no failures occurred due to the inability to dilate the lesion or deploy stents. Arterial access was clearly not a problem, with both surgical and percutaneous techniques as part of the armamentarium. The effect on cost is less clear. The hardware necessary to perform these procedures (balloon catheters, sheaths, wires, and stents) can be expensive and is more costly than grafts and suture. There appears to be an advantage, however, by avoiding costly intensive care unit stays and subsequent in-hospital care. It does seem, however, that the cost advantage may be lost if procedures are staged. It could be argued that the increased average charge of diagnosis-related group procedure 39.25 reflects patient selection. However, there were three additional surgeons operating at our institution during this time period, all performing standard operations, and it is the opinion of the authors that this observation represents the comorbidity of an older and sicker population. The observation that the hospital charges were not different for nonstaged procedures, along with the fact that the three areas of angiographically documented recurrence were in nonstented portions of the artery, suggest that if the surgeon favors using additional stents, or treating the opposite side, this probably should be performed at the same setting. Functional improvement was difficult to assess retrospectively. ABI measurement groups were small, and al-
204
though improvement occurred in all groups, significanl numbers of patients were excluded due to insufficient pre. operative data. Although functional assessment preoperatively and postoperatively was more subjective, it wa., available in all patients and shows significant improvemen~ in all groups. There was also a beneficial effect in class L patients. Only three patients required amputation, all afte~ 30 days. No patient in either class 3 or 4 other than those who experienced an initial failure required conversion t~ a standard surgical procedure. Follow-up is short, and clinical assessment of patenc3 can be misleading. Longer follow-up is necessary to as sess the durability of this procedure, with prospective as sessment, and invasive study of failures, particularly in th~ group of patients with more diffuse disease requiting mul tiple, serial stents. Finally, the cardiology and radiology literature is replett with reports of percutaneous endoluminal therapy for pe ripheral atherosclerotic occlusive disease. By contrast, th, subject index published in the Journal o f Vascular Surger for 1993 lists fewer than 15 references to endovascul~ techniques. 9 Surgeons have, as a specialty, largely ignore, technology that may hold the key to the future of vascu lar surgery. This study, although deficient in long-term follow-up as sessing durability, shows the feasibility of applying thes techniques to diffuse aorto-iliac disease. Surgeons shoul, become involved to the greatest extent possible, to assur, that the proper "niche" for this technology is achieved.
REFERENCES
1. Pentecost MJ, Criqui MH, Dorros G, et al. Guidelines for peript eral percutaneous transluminal angioplasty of the abdominal aorT and lower extremity vessels: a statement for health professionals fro~ a special writing group of the councils on cardiovascular radiolog, arteriosclerosis, cardio-thoracic and vascular surgery, clinical card ology, and eptdemiology and prevenuon, the American Heart Assoc ation. Circulation. 1993;89:511-531. 2. Manmck JA, Whittemore AD. Aorto-iliac occlusive disease, lJ Moore WS, ed. Vascular Surgery. A Comprehensive Revie* Philadelphia: W.B. Saunders, 1991;350-362. 3. Penn IM, Levine SL, Schatz, RA. Intravascular stents as an at junct to endovascular intervention. In: Moore WS, Ahn SS, ed Endovascular Surgery. Phdadelphia: W.B. Saunders, 1989;258-27' 4. DeWeese JA, Leather R, Porter J. Practice guidelines: lower e: tremity revascularization. J Vase Surg. 1993;18:280-294. 5. Richter GM, Roeren TH, Noeldge G, et al. First long term resul of a randomized multicenter trial; ihac balloon expandableste~ placement versus regular percutaneous transluminal angioplast Radiology. 1992;177(P): 152. Abstract. 6. Palmaz JC. Intravascular stents: tissue-stent interactions and d, sign considerations. Am J Roentgenol. 1993;160:613-618. 7. Palmaz JC, Encarnacion CE, Garcia OJ, et al. Aortic bifurcatic stenosis: treatment withintravascular stents. J Vase Interv Radic 1991;2:319-323. 8. Palmaz JC. Intravascular stenting: from basic research to clinic application. Cardiovasc lntervent Radiol. 1992;15:279-284. 9. Subject index. J Vasc Surg 1993;18:1104-1122.
THE AMERICANJOURNAL OF SURGERY® VOLUME 168 AUGUST 1994
PURPOSE: We retrospectively evaluated balloon angioplasty with intraluminal stenting to define applicability, early results, cost, and length of stay. METHODS: Seventy-three patients underwent 9 4 aorto-iliac angioplasties with intraluminal stents from October 1 9 9 1 through July 1 9 9 3 . All had disabling claudication or rest ischemia.
stenting in all patients presenting with atherosclerotic oc clusive disease of the iliac arteries who require treatmenl
PATIENTS AND METHODS From October 1991 through July 1993, 83 patients un dergoing 104 procedures presented for treatment of symp tomatic aorto-iliac occlusive disease. All patients who pre RESULTS: Mean follow-up was 10.2 months and sented for treatment of aorto-iliac disease were initiail, attempted to be treated by balloon angioplasty with intra was 90.4% complete. Ninety percent of procedures were immediately successful. T h e r e were no luminal stenting. The procedure was considered a failur~ deaths within 3 0 days of surgery. Complications in 10 patients (10 procedures) due to the inability to cros , occurred in 1 3 % . The anlde:brachial indices imlesions, leaving 73 patients (47 men, 26 women) under proved in all groups. Functional class improved in going 94 iliac balloon angioplasties with implantation o an groups. In class 4, limb salvage o r a benefit on intraluminal stents who comprise the study group for thi level of amputation was universal. Length o f stay report. The average age of patients was 68 years (range 4 ranged 33% to 82% less than when aorto-iliac or to 87). All patients were severely symptomatic with eithe aortofemoral bypass were undertaken (diagnosisdisabling claudication (45 patients) or rest ischemia (2: patients), Nineteen of 73 patients (26%) were diabetic, 6: related group 39.25). Hospital charges for stent procedures ranged 25% to 6 6 % less than for of 73 (89%) had history of cigarette smoking, 30 of 7. aorto-iliac or aortofemoral bypass (diagnosis-re(41%) had prior history of myocardial infarction or stroke and 42 of 73 (58%) had history of hypercholesterolemia lated group 39.25). CONCLUSION: T h e p r o c e d u r e is widely applicable, The procedure was considered a failure if lesions could no with an apparent initial advantage in mortality, be crossed with guidewires, if luminal patency could no morbidity, charges, and length of stay. Durability be restored or augmented, or if intraluminai stents couh is unproven. not be satisfactorily deployed. Simultaneous or subsequen distal reconstructive procedures were performed in 20 o ndoluminal treatment of atherosclerotic arterial occlu- 94 procedures (21%). Renal failure was defined by a 50~ sive disease of the aorto-iliac segment is theoretically rise in the serum creatinine level. Distal embolization oc appealing for its potential to reduce procedure-related mor- curred if the typical "trash foot" pattern or "blue toe" syn bidity, 30-day mortality, and hospital length of stay. 1 drome was observed postoperatively. All procedures wer, Although balloon angioplasty is generally reserved for dis- undertaken in a specially equipped endovascular suit, crete lesions, L2 its applicability and incidence of compli- (International Surgical Systems, Phoenix, Arizona) con cations when used in lesions of a more diffuse nature are sisting of a specially designed operating table witJ unknown, and restenosis remains a barrier to the durabil- roentgenographic equipment. The interventional suite wa ity of isolated balloon angioplasty. 3,4 Endoluminal stent- equipped with general anesthesia technology and con ing in conjunction with balloon angioplasty offers the pos- tained instrumentation for both endoluminai and standarq sibility of favorably altering the incidence of restenosis surgical procedures, which could be performed concomi seen with balloon angioplasty alone. 3 However, deploy- tantly if necessary. ment of multiple stents in areas of diffuse atherosclerosis For purposes of comparing hospital charges and hospi likewise is an undefined procedure.3 This retrospective re- tal length of stay, patients undergoing stent procedure view was conducted to direct further analysis into the ap- were divided into three groups: A (unilateral procedure~, plicability, early results, morbidity, mortality, and cost ef- 53 patients/53 procedures), B (bilateral procedures, sam fectiveness of balloon angioplasty with endoluminal setting, 9 patients/18 procedures), and C (bilateral proce dures, different settings, 11 patients/23 proceduresl Additionally, these groups were compared with diagnosis related group (DRG) procedure 39.25 (aorta-iliac-femor~ From the AbileneHeartand VascularInstitute,Abnlene,Texas. This studywas supportedin part by an educationalgrantfromJohnson bypass) and DRG procedure 39.29 (other peripheral vas & Johnson InterventionalSystemsCo., 35 TechnologyDrive, Warren, cular shunt or bypass) with regard to average hospit~ New Jersey. charges and length of stay during the same time frame Requests for reprintsshouldbe addressedto James B. Williams,MD, Functional class assessment preoperatively and postopex 1665 AntilleyRoad, Suite 250, Abilene,Texas79606. Presented at the 22nd Annual Meeting of the Society for Clinical atively is defined as follows: class 1--asyml~tomatic; clas Vascular Surgery,Tucson,Arizona,March2--6, 1994 2--symptoms with moderate activity; class 3--symptom
E
202
THE AMERICANJOURNALOF SURGERY® VOLUME168 AUGUST1994
BALLOON ANGIOPLASTYWITH INTRALUMINALSTENTING/NgllJJ'AMS'I?.T,,AL
with minimal activity, refractory to medical management; and class 4 symptoms at rest, motor or sensory loss, ischemic soft tissue changes. Each patient was given a corresponding numerical functional class value, so that average postoperative functional class could be calculated. All procedures were performed in patients under regional or general anesthesia, utilizing systemic heparinization. Heparin was reversed at the termination of the procedure o~ shortly afterward in the recovery area. No postoperatwe anticoagulation was employed. Follow-up consisted of direct patient examination by the ptlysican-author in routine follow-up visits, or by telep~lone interviews of patients, and was achieved in 66 t"0.4%) of patients. Follow-up ranged from 0 to 27 months ~th a mean of 10.9 months. ?reoperative ankle:brachial indices (ABI) were not avail,~le in many patients for the following reasons: (1) ur~,:ncy in limb salvage situations, which precluded their I ,:rformance; (2) accompaniment of outside studies (which ere not repeated) that did not contain ABI as part of the . ~sessment; and (3) performance of ABI was not neces, Lry to document the diagnosis of limb ischemia. Palmaz balloon expandable stents (P308, Johnson & ,~hnson Interventional Systems Co., Warren, New Jersey) ere employed exclusively. Meditech balloons catheters 8oston Scientific Co., Watertown, Massachusetts) of apt'opriate diameter and length were used, in addition to bal,on catheters on which some Palmaz stents were factory ~ounted. Sheaths were appropriate sizes and lengths manfactured by Cook (Cook Group Company, Bloomington, ~diana) or Meditech. Wires were either the Meditech ,lidewire or Wholey wire (Mallinckrodt Medical, Inc., St. ouis, Missouri) of a length of .035 inches. Percutaneous ' ocedures (36% or 38%) were performed using standard ,:ldinger technique. Contrast was Isovue 370 (Schmidt ~lagnostics, Bristol-Myers Squibb, Princeton, New ,'.rsey) diluted two parts contrast with one part normal Aine. Open procedures (58% or 62%) were performed ~a short cutdowns over the common femoral artery, or if dditionai distal procedures were anticipated, with a stanard femoral artery dissection. No intraoperative thromolysis of iliac segments as part of the operative procedure 'as performed. "{ESULTS There were no deaths within 30 days of the procedure. Complications occurred in 12 of 94 procedures (13%). "here were 6 superficial wound infections, 2 mispositioned .tents (none with clinical consequences), 1 common iliac :lrombosis, which responded to thrombolytic agents, 2 pa?ehts had cellulitis distal to the operative site, presumably !ue to ischemia at the time of presentation, and 1 case of ~rinary retention requiring transurethral resection of the ~rostate. There were no cases of postoperative renal fail~re, and no evidence of distal embolization was found. Endoluminal treatment was successful as the initial ~lodality in 73 of 83 patients (94 of 104 procedures) who )resented for treatment during the study period. Lesions ailing endoluminal therapy included 7 total iliac occlu..ions, 2 infrarenal aortic occlusions, and 1 retrograde ia~rogenic dissection. No failures were attributable to in-
TABLE I Changes in Ankle:Brachial Indices Total Group" Class 3" Preoperatively .650 .697 Postoperatively .737 .773 "Priorto or withoutsubsequentdistalprocedure.
Class 4" .475 .603
TABLE II Hospital Length of Stay and Charges Length of Stay (days) Charges ($) Group A 2.55 15,594 Group B 5.43 15,647 Group C 9.45 34,803 DRG39.25 14.10 46,253 DRG39.29 12.10 21,290
ability to access the artery, or, once the lesions were crossed, inability to dilate the artery or deploy the stent(s). All failures were due to inability to traverse the lesion with guidewires. A total of 44 angioplasties (47%) utilized 1 stent, 37 (39%) used 2 or 3 stents, and 13 (14%) used 4 or more stents. An average-of 2.1 stents were used per procedure (range 1 to 7). No technical successes required conversion to standard operative procedures, either acutely or during the follow-up period. Functional class improvement was assessed in those 85 procedures without or prior to distal reconstruction and improved for the group from an average of 3.38 preoperatively to 1.60 postoperatively (an improvement of 1.78 functional classes). Class 3 improved to 1.59 (an improvement of 1.41 functional classes), and class 4 improved to 1.62 (an improvement of 2.38 functional classes). ABI change in patients in whom both preoperative and postoperative ABIs were available were assessed prior to a distal procedure, if any (38 patients of 52 procedures), and are depicted in Table I. The effect on limb salvage was assessed for 28 patients in functional class 4. Two patients required amputation within 30 days (both digital). Five patients required amputations after 30 days (2 digital, 3 below the knee). Eight patients in class 4 required distal reconstructive procedures, 3 within 30 days of stenting, and 5 after 30 days from stenting. All patients requiring amputation presented with some irreversible ischemic skin or soft-tissue changes. A benefit in limb salvage or level of amputation was universal. Angiographically documented recurrence occurred in three patients during the study period; all recurrences were due to lesions in nonstented areas. The analysis of hospital length of stay and hospital charges is shown in Table H. COMMENTS Establishment of arterial inflow in cases of exercise or rest ischemia of the lower extremities caused totally or in part by aorto-iliac occlusive disease traditionally has been achieved in good risk patients by aortobifemoral bypass grafting (ABF), or in higher risk patients by femoro-
THE AMERICANJOURNALOF SURGERY* VOLUME168 AUGUST1994 2 0 3
BALLOON ANGIOPLASTY WITH INTRALUMINAL STENTING/WILLIAMS ET AL
femoral (CF) or axillobifemoral (AXBF) bypass grafting. Although these procedures are very effective (5 years patencies of 70% to 80%) and low risk (30 day mortalities of 1% or less for ABF, 2% to 5% for CF, AXBF), they are not performed without significant morbidity or hospital stay. 2 Less invasive procedures, receiving a great deal of attention in the cardiology and radiology literature, 5-s deserve consideration as to their role in this setting. Admittedly, this review is not a randomized prospective comparison of standard and nonstandard surgical techniques and has the usual shortcomings associated with retrospective analysis. Nonetheless, it does raise some worthwhile questions regarding mortality, morbidity, applicability, cost, and hospital length of stay associated with endoluminal therapy. Despite multiple risk factors and advanced age in these patients, hospital mortality was zero. This may be attributable to a lower physiologic stress associated with this procedure. Complications were low in number and were, for the most part, not of a life-threatening nature. Adequate hydration and the use of dilute contrast contributed to the absence of postoperative renal failure. Although the use of preoperative and intraoperative thrombolytic agents might increase the technical success rate, it also might contribute to the absence of distal embolization noted in this patient population. The mispositioned stents occurred early in the physician-author's experience and had no adverse clinical consequences. They were managed by deployment, not retrieval. Technical success was high. Failures occurred most often with chronic occlusion. Despite a large number of patients with diffuse disease, no failures occurred due to the inability to dilate the lesion or deploy stents. Arterial access was clearly not a problem, with both surgical and percutaneous techniques as part of the armamentarium. The effect on cost is less clear. The hardware necessary to perform these procedures (balloon catheters, sheaths, wires, and stents) can be expensive and is more costly than grafts and suture. There appears to be an advantage, however, by avoiding costly intensive care unit stays and subsequent in-hospital care. It does seem, however, that the cost advantage may be lost if procedures are staged. It could be argued that the increased average charge of diagnosis-related group procedure 39.25 reflects patient selection. However, there were three additional surgeons operating at our institution during this time period, all performing standard operations, and it is the opinion of the authors that this observation represents the comorbidity of an older and sicker population. The observation that the hospital charges were not different for nonstaged procedures, along with the fact that the three areas of angiographically documented recurrence were in nonstented portions of the artery, suggest that if the surgeon favors using additional stents, or treating the opposite side, this probably should be performed at the same setting. Functional improvement was difficult to assess retrospectively. ABI measurement groups were small, and al-
204
though improvement occurred in all groups, significanl numbers of patients were excluded due to insufficient pre. operative data. Although functional assessment preoperatively and postoperatively was more subjective, it wa., available in all patients and shows significant improvemen~ in all groups. There was also a beneficial effect in class L patients. Only three patients required amputation, all afte~ 30 days. No patient in either class 3 or 4 other than those who experienced an initial failure required conversion t~ a standard surgical procedure. Follow-up is short, and clinical assessment of patenc3 can be misleading. Longer follow-up is necessary to as sess the durability of this procedure, with prospective as sessment, and invasive study of failures, particularly in th~ group of patients with more diffuse disease requiting mul tiple, serial stents. Finally, the cardiology and radiology literature is replett with reports of percutaneous endoluminal therapy for pe ripheral atherosclerotic occlusive disease. By contrast, th, subject index published in the Journal o f Vascular Surger for 1993 lists fewer than 15 references to endovascul~ techniques. 9 Surgeons have, as a specialty, largely ignore, technology that may hold the key to the future of vascu lar surgery. This study, although deficient in long-term follow-up as sessing durability, shows the feasibility of applying thes techniques to diffuse aorto-iliac disease. Surgeons shoul, become involved to the greatest extent possible, to assur, that the proper "niche" for this technology is achieved.
REFERENCES
1. Pentecost MJ, Criqui MH, Dorros G, et al. Guidelines for peript eral percutaneous transluminal angioplasty of the abdominal aorT and lower extremity vessels: a statement for health professionals fro~ a special writing group of the councils on cardiovascular radiolog, arteriosclerosis, cardio-thoracic and vascular surgery, clinical card ology, and eptdemiology and prevenuon, the American Heart Assoc ation. Circulation. 1993;89:511-531. 2. Manmck JA, Whittemore AD. Aorto-iliac occlusive disease, lJ Moore WS, ed. Vascular Surgery. A Comprehensive Revie* Philadelphia: W.B. Saunders, 1991;350-362. 3. Penn IM, Levine SL, Schatz, RA. Intravascular stents as an at junct to endovascular intervention. In: Moore WS, Ahn SS, ed Endovascular Surgery. Phdadelphia: W.B. Saunders, 1989;258-27' 4. DeWeese JA, Leather R, Porter J. Practice guidelines: lower e: tremity revascularization. J Vase Surg. 1993;18:280-294. 5. Richter GM, Roeren TH, Noeldge G, et al. First long term resul of a randomized multicenter trial; ihac balloon expandableste~ placement versus regular percutaneous transluminal angioplast Radiology. 1992;177(P): 152. Abstract. 6. Palmaz JC. Intravascular stents: tissue-stent interactions and d, sign considerations. Am J Roentgenol. 1993;160:613-618. 7. Palmaz JC, Encarnacion CE, Garcia OJ, et al. Aortic bifurcatic stenosis: treatment withintravascular stents. J Vase Interv Radic 1991;2:319-323. 8. Palmaz JC. Intravascular stenting: from basic research to clinic application. Cardiovasc lntervent Radiol. 1992;15:279-284. 9. Subject index. J Vasc Surg 1993;18:1104-1122.
THE AMERICANJOURNAL OF SURGERY® VOLUME 168 AUGUST 1994