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Isolated profundaplasty for limb salvage
Isolated profundaplasty for limb salvage David L. Rollins, M.D., Jonathan B. Towne, M.D., Victor M. Bernhard, M.D., and P a t r i d a L. Baum, B.S.N., Milwaukee, Wise. Fifty-four patients underwent 56 profundaplasties for limb salvage. All had stenosis > 50% in diameter of the deep femoral artery and associated superficial femoral artery occlusive disease. After profundaplasty, ischemic ulcers healed in 9 of 17 (53%) patients. Rest pain was relieved in 6 of 19 (32%) and areas of ischemic necrosis healed in 7 of 20 (35%). Cumulative patency of the deep femoral artery was 49% at 3 years but fell to 21% at 5 years, whereas cumulative limb salvage was 49% and 36%, respectively. Eleven of the required 28 amputations were performed in the immediate postoperative period. Profundaplasty was used to lower the amputation level and preserve the knee joint in six patients. The other five early amputations occurred in severely ischemic limbs without distal vessels suitable for bypass. The profundaplasty remained patent in all 19 patients who underwent below-knee amputation and 16 (84%) became ambulatory with a prosthesis. Hemodynamic data provided by determination of the profimdapopliteal collateral index predicted limb salvage in 10 of 11 (91%) of limbs when the index value was ~<0.19. Other clinical criteria, such as preoperative ankle-brachial index and the presence of diabetes mellitus, had no predictive value. Isolated profimdaplasty for limb salvage is an effective first procedure for selected patients and provides a reasonable alternative to primary amputation or high-risk distal bypass. When amputation is inevitable, effective perfusion of the proftmda femoris artery is essential for preservation of the knee joint and results in a high degree of functional rehabilitation. (J VAse SURG 1985; 2: 585-90.)
The deep femoral artery is the major collateral pathway to the popliteal and distal leg arteries when the superficial femoral artery is obstructed. Previous studies by Strandness 1 and Wright 2 have demonstrated that correction ofstenosis of the deep femoral artery associated with superficial femoral and popliteal artery occlusive disease significantly increases (ower extremity blood flow, which relieves ischemic symptoms. We have previously shown that profundaplasty alone to treat claudication is an efficacious and durable procedure. 3 However, when isolated profundaplasty is performed to provide limb salvage, it has yielded variable results in the healing of ischemic ulcers or necrosis and relief of rest pain. David and Drezner 4 were successful in relieving ischemic symptoms in 86% of their patients whereas Mitchell et alfi had success in only 45%. Several authors have addressed this issue by attempting to define criteria for selection o f patients who will benefit from isolated profundaplasty. Many variables have been considFrom the Department of Surgery,Me&calCollegeof Wisconsin. Reprint requests: David L, Rollins,M.D., Dept. of Surgery,Universlty of Health Sciences/TheChicagoMedical School, 3333 Green Bay Rd., North Chicago, IL 60064.
ered, including arteriographic patterns, extent of disease, segmental pressure measurements, and blood flow assessment during s u r g e r y . 4-6 The purpose of this article is to use both clinical and hcmodynamic criteria to determine the long-term durability of profundaplasty alone performed to effect limb salvage and to identify those patients in whom isolated profundaplasty will be most efficacious. MATERIAL AND METHODS From 1971 to 1980, 54 patients underwent 56 isolated profundaplasties. The group consisted of 41 men and 13 women aged 46 to 97 years (mean 64 years). Sixteen (29%) were diabetic. Prior vascular procedures involving the ipsilateral extremity had been performed in only three patients. The indications for vascular reconstruction were ischemic ulcers, rest pain, or areas of pedal ischemic necrosis. Preoperative studies included biplanar aortobifemoral angiography and, in most cases, segmental Doppler examination. Adequacy of inflow was assessed by palpation of femoral pulses, review of arteriograms, and intraoperative pressure and flow measurements. Preoperative segmental pressure measurements werc available in 31 limbs. The fractional 585
IournNof
VASCULAR SURGERY
586 Rollins et al.
90
Table II. Late results of isolated profiandaplasty in 42 (75%) limbs
80 70
No. of limbs ~ 60 50
...............................
:ilIi .7 ,
40 30 20 I0 0 I
b
I
I
I
L
I
6
12
18
24
36
48
60
MoN s
Profimdaplastypatent Patient without symptoms Distal bypassrequired for limb salvage Profundaplastyoccluded Required inflowprocedure; "redo" profundaplasty for limb salvage Required amputation
22 (53) 6 (14) 3 (7) 11 (26)
*Numbers in parentheses represent percentages.
..-7
Fig. 1. Cumulativc patency and limb rctcntion in 56 limbs undergoing isolated profundaplasty for limb salvage. Table I. Early results (30 days) of isolated profundaplasty in 56 (100%) limbs No. of limbs ~
Profundaplasty patent Limb salvaged Distal bypass required for limb salvage Required amputation
42 (75) 3 (5) 11 (20)
~Numbers in parentheses represent percentages.
pressure decrease across the knee or profundapopliteal collateral index (PPCI) was expressed as follows: above knee pressure - below knee pressure above knee pressure PPCI was measured in these patients and reflected the resistance of the collateral bed. All patients had occlusion or multilevel stenosis of the superficial femoral artery and >50% stenosis of the deep femoral artery. The operative technique consisted of an artcriotomy in the common femoral artery, which was carried distally into thc deep femoral artery beyond the distal extent of the occlusive discase. 7 An endarterectomy was performed if thc luminal surface was ulcerated or irregular. The artcriotomy was closed with a patch of autogenous tissue, usually a segmcnt of endartcrectomized superficial femoral artery, or less frcqucntly, autogcnous vein. For the purposes of analysis, the length of the profundaplasty was divided into short (<2 cm), standard (<8 cm or beyond the laterofemoral circumflex branch to the first perforator), and extended (>8 cm or beyond the first perforator).
The profundaplasty was considered patent if there was an increase in the ankle/brachial index (ABI) of at least 0.1. The repair was considered a failure if the femoral pulse disappeared, if the vessel was anglo I graphically demonstrated to be occluded, or if the ABI returned to preoperative levels. If a subsequent distal bypass was needed to maintain limb salvage, the proftmdaplasty was considered a failure. The patients were followed up for as long as 110 months postoperatively and assessment of the patients' clinical condition and vascular laboratory studies were performed at regular intervals. Graft patency and limb retention were analyzed by the life-table method; perioperative ABI and preoperative PPCI, by Student's t test. RESULTS Postoperative results of the 56 isolated profundaplasties performed are summarized in Table I. The procedure was successful in 42 (75%) patients as evidenced by healing of ischemic ulcers, resolutio~ of rest pain, and healing of areas of ischemic pedal necrosis, either primarily or with ddbridement or minor amputation. Three patients with stenosis of the deep femoral artery and extensive distal occlusive disease required a distal bypass to salvage the extremity. Although the profundaplasty remained patent in all three patients, one required a below-knee amputation (BKA) at 4 months for recurrent ischemia from dbtal graft failure. Eleven limbs (20%) underwent early amputation. The profundaplasty was done in six limbs to lower the level of amputation from above to below the knee. All these patients had extensive areas of pedal necrosis, which necessitated amputation of the foot. The other five early amputations were performed to control persistent gangrene and sepsis and were considered failures of profundaplasty. The late results of the surviving 42 limbs are
Volume 2 Number 4
July1985
Isolated profundaplasty for limb salvage
5 87
£able III. Amputations in diabetic and nondiabetic patients
All limbs (n = 56) Patients with diabetes (n = 16) Patients without diabetes (n = 40)
AICA
BICt
Total
No. (%)
No. (%)
No. (%)
9 (16) 0 (0) 9 (23)
19 (34) 7 (44) 12 (30)
28/56 (50) 7/16 (44)
21/40 (53)
Table IV. Perioperative ABIs in 68 limbs of patients undergoing isolated profundaplasty
Mean preoperative ABI Mean postoperative ABI
All limbs
Amputated limbs
Salvaged limbs
0.37 0.45 (p = NS)
0.27 0.25 (p = NS)
0.42 0.55 (p < 0.0009)
~ o w n in Table II. Twenty-two limbs remained asymptomatic throughout the follow-up period. An additional six limbs had patent profundaplasties but required distal bypass procedures between the second and fifth months to control recurrent ischcmia from progressive atherosclerotic disease. During the follow-up period five of the six distal bypasses occluded, which made amputation necessary. In two of these patients the profundaplasty also occluded. Three late profundaplasty occlusions were successfully treated, which resulted in limb salvage. In two patients progression of proximal occlusive disease required thrombcctomy of the deep femoral artery and inflow procedures, and in one patient recurrent stenosis of the deep femoral artery was treated with patch angioplasty. Eleven amputations were required from 13 to 52 months postoperatively; nine for gangrene and sepsis and two for chronic rest pain caused by ,~rogression of disease. Overall cumulative patency of the deep femoral artery (Fig. 1), calculated by the life-table method, was 49% at 3 years but fell to 21% at 5 years. Similarly cumulative limb salvage was also 49% at 3 years but fell to 36% at 5 years. Twenty-eight amputations were performed (Table III); 20 were done to control septic gangrene and eight for progressive ischemia. The profundaplasty occluded in all nine patients who underwent aboveknee amputation (AKA). Of the 19 patients who underwent BKA 16 (84%) became ambulatory with the use of a prosthesis, including the six who had a planned profundaplasty to salvage the knee joint. There was no significant difference in the number of amputations in the groups with or without diabetes. Twenty-eight limbs had preoperative and postoperative ABI values available for comparison (Table IV). Overall the mean ABI increased by 0.07. How-
ever, in limbs that required eventual amputation, there was actually an average decrease of 0.02. The postoperative ABI was significantly higher in limbs that did not require eventual amputation (p < 0.0009). In 15 of 19 (79%) limbs the ABI increased by more than 0.1. Prcoperative PPCls were calculated in 31 limbs and correlated with the success of profundaplasty determined by the need for amputation (Table V). PPCI <0.19 indicated successful profimdaplasty in 10 o f l l (91%) of limbs. When the PPCI was >0.45, all six limbs required amputation. PPCIs between 0.20 and 0.44 were indeterminate. The results of the operative procedure in relation to clinical presentation were analyzed in all limbs (Table VI). Profimdaplasty was considered successful if it relieved rest pain, healed ischemic ulcers, or healed gangrenous areas primarily or after ddbridement or minor amputation. When only patients with ischemic ulcers were considered, 9 of 17 (53%) healed. One limb ulcer healed initially but the patient required an inflow procedure and "redo" profundaplasty at 34 months. Significant aortoiliac obstruction was overlooked in one patient who required an inflow procedure to control persistent ischemia on the first postoperative day. Six patients in the ischemic ulcer group had early amputations: two AKAs were performed to treat progressive ischemia following profundaplasty occlusion. Four BKAs were required; three to control persistent ischemia or cellulitis, and one was planned to lower the amputation level to below the knee. Only 6 of 19 (32%) patients with rest pain remained without symptoms throughout the followup period. Three others did well after additional distal bypass but 10 ultimately required amputation. In five patients AKA was performed after the profun-
Journal of VASCULAR SURGERY
588 Rollins et al.
Table V. Preoperative PPCI in 31 limbs undergoing isolated profundaplasty PPCI
Limb salvage
Amputation
40.19 (n - 11) 0.20 to 0.44 (n = 14) >0.45 (n = 6)
10 6 0
1 8 6
Table VI. Operative indications and long-term results Success
Failure
Indication
No. of patients (%)
No. of patients (%)
Ischemic ulcer (n = 17) Rest pain (n = i9) Ischemic necrosis (n = 20)
9 (53) 6 (32) 7 (35)
8 (47) 13 (68) 13 (65)
daplasty occluded, and five BKAs were performed in patients with patent profundaplasties. Ischemic necrosis resolved in only 7 of 20 limbs (35%). A minor amputation site healed in one patient following distal bypass but 12 patients required amputation. Ten patients had BKAs; profundaplasty was done to salvage the knee joint in five of these. The profundaplasty had occluded in the two patients who required AKAs. DISCUSSION
Isolated profundaplasty was initially performed to effect limb salvage as an alternative to the early disappointing results of femoropopliteal bypass by Martin et al.8-10 Later it was used as the initial approach to distal ischemia by Modgill et al. n and by Ward and Morris-Jones ~2 and in high-risk patients by Cohn et al.~3 Recent reports have attempted to both determine the efficacy of isolated profundaplasty and develop specific criteria for patient selection. 4-6 When performed to achieve limb salvage, the effectiveness of isolated profundaplasty rapidly d e cays with time. David and Drezner 4 described successful limb salvage in 86% of patients followed up for an average of 19 months, whereas Morris-Jones and Jones 14avoided amputation in only 36% of limbs at 12 months of follow-up. In our study limb salvage was achieved in 57% at 12 months and 52% at 18 months but showed a continued decline to 36% at 5 years. These data emphasize the need for better patient selection and prompted several authors to look at different clinical criteria. Cotton and Roberts ~s and Malone ctal. 16both found diabetes mellitus adversely
influenced patency of the deep femoral artery. In our study, however, there was no significant difference between diabetic (44%) and nondiabetic (53%) patients. The results of the operation in relation to dinical presentation have been extensively investigated. 4,s,ll,lz In general the results of isolated profundaplasty are most successful in patients with nonhealing ischemic ulcers, less successful for rest pain, and the poorest results Occur with ischemic gangrene. These indications form a type of physiologic continuum correlating with increasing vascular resistance and decreasing arterial flow from progressive arterial obstructive disease. The success of profundaplasty is thought to be determined by several factors in addition to stenosis of the deep femoral artery itself.4,12,17,18The most important of these determinants is the adequacy of the profundapopliteal collatero-' system and the severity of tibial arterial occlusive discase. Assessment of obstructive disease based on arteriographic features has bccn stressed by many authors but without uniform findings. Mitchell et al.s reviewed these criteria and reported that arteriography reliably predicts successful profundaplasty when the following conditions exist: (1) minimal occlusive disease of the distal profunda femoris artery, (2) a well-developed profunda femoris collateral system, (3) patent poplitcal artery, and (4) minimal tibial outflow occlusive disease. Hcmodynamic criteria from noninvasive vascular laboratory data have been extensively investigated by numerous researchers. ~-There is a significant increase *References 1, 4, 5, 17-20.
Volume 2 Number 4 July 1985
m the mean postoperative ABI in those patients in whom profundaplasty was successful and a slight decrease in ABI when failure occurred. Wright 2 documented increased limb flow by xenon studies following successful profundaplasty, but neither he nor Morris-Jones and Jones I4 found a change in the perioperative ABI. Our study confirmed a significant mean increase in postoperative ABI in successful profundaplasty. However, ABI only quantified total limb resistance caused by arterial obstruction but did not localize the level of obstruction and was of no predictive value. Segmental pressure measurements, however, can locate and determine the extent of occlusive disease by providing an estimate of the resistance in each collateral bed. Boren et al.6 showed that PPC1 accurately preticts the resistance of the geniculate collateral pathways, which is the most important determinant of profundaplasty success. In our study the PPCI predicted limb salvage in 10 of 11 (91%) limbs when it was ~<0.19. It is interesting that the PPCI correlated well with the operative indications. The mean PPCI was 0.19 in patients with nonhealing ulcers, 0.21 with rest pain, and 0.29 with ischemic gangrene. These data agree with the concept of a physiologic continuum based on increasing vascular obstruction and more severe ischemic derangements. The study of David and Drezner 4 supports this concept, showing that 8 of l l (72%) limbs with gangrene had arteriographic evidence of popliteal occlusion compared with only 10 of 39 (26%) of limbs with rest pain. An additional benefit of profundaplasty noted in this study was the lowering of the major amputation level to below the knee in six patients in whom the extent of pedal tissue necrosis precluded foot salvage. Profundaplasty was performed several days before planned amputation in these patients and all became ambulatory with the use of a prosthesis. Overall 16 of 19 (84%) patients who required BKA were functionally rehabilitated. The concept of the profunda femoris artery as a collateral bed is useful in determining which patients may benefit from this procedure. In this study hemodynamic data provided by determination of the PPCI from segmental limb pressures had significant value. Arteriographic assessment also appears to have prognostic value and its use would complement hemodynamic data in making better patient selection for isolated profundaplasty. Other clinical criteria, such as preoperative ABI or presence of diabetes mel-
Isolated profundaplasty for limb salvage 589
litus, have no predictive value. Clinical presentation may indicate the severity of distal occlusive disease and be a useful determinant as to which reconstructive alternatives should be employed. Profundaplasty alone appears to be efficacious in healing ischemic ulcers and abolishing rest pain but frequently does not heal areas of ischemic gangrene. The postoperative success of profundaplasty may be determined by monitoring the ABI. ABI is usually increased by more than 0.1 in patients who benefit from profundaplasty procedures. Although profundaplasty to achieve limb salvage is effective in only 36% of patients at 5 years, it is an appropriate first procedure in most patients with stenosis of the profunda femoris artery. When simultaneous stenosis of the proftmda femoris artery and femoropopliteal occlusive disease occur, isolated profundaplasty will frequently result in limb salvage. Higher risk distal bypass may be employed later if necessary. In patients who have an occluded distal bypass with poor runoff and concomitant stenosis, isolated profundaplasty often results in limb salvage. In addition, it may provide effective perfusion for preservation of the knee joint. When amputation is inevitable, a BKA usually results in a high degree of functional rehabilitation. REFERENCES 1. Strandness Jr DE. Functional results after revascularization of the profunda femoris artery. Am J Surg 1970; 119: 240-5. 2. Wright CJ. Effect of femoral profi.mdaplasty on blood flow. Can J Surg 1983; 26:328-7. 3. Towne JB, Bernhard VM, Rollins DL, Baum PL. Profundaplasty in perspective: Limitations in the long-term management of limb ischemia. Surgery 1981; 90:1037-46. 4. David TE, Drezner DA. Extended profundaplasty for limb salvage. Surgery 1978; 84:758-63. 5. Mitchell RA, Bone GE, Ridges R, Pomajzi MJ, Fry WJ. Patient selection for isolated profundaplasty. Arteriographic correlates of operative results. Am J Surg 1979; 138:912-9. 6. Boren CH, Towne JB, Bernhard VM, Salles-Cunha S. Profimdapopliteal collateral index. A guide to successful profundaplasty. Arch Surg 1980; 115:1366-72. 7. Bernhard VM, Militello JiM, Geringer AM. Repair of the profimda femoris artery. Am J Surg 1974; 127:676-9. 8. Martin P, Renwick S, Stephenson C. On the surgery of the profunda femoris artery. Br J Surg 1968; 55:539-42. 9. Martin P, Frawley JE, Barabas AP, Rosengarten DS. On the surgery of atherosclerosis of the profimda femoris artery. Surgery 1972; 71:182-9. 10. Martin P, Jamieson C. The rationale for and measurement after profundaplasty. Surg Clin North Am 1974; 54:95-109. 11. Modgill VK, Humphrey CS, Shoesmith JH, Kester RC. The value of profundaplasty in the management of severe femoropopliteal occlusion. Br J Surg 1977; 64:362-4.
590
Rollins et al.
12. Ward AS, Morris-Jones W. The long-term results ofprofundaplasty in femoropopliteal arterial occlusion. Br J Surg 1977; 64:365-7. l& Cohn LH, Trueblood W, Crowley LG. Profunda femoris reconstruction in the treatment of femoropopliteal occlusive disease. Arch Surg 1971; 103:475-9. 14. Morris-Jones W, Jones CDP. Profimdaplasty in the treatment of femoropopliteal occlusion. Am J Surg 1974; 127:680-6. 15. Cotton LT, Roberts VC. Extended deep femoral angioplasty: An alternative to femoropopliteal bypass. Br J Surg 1975; 62:340-3. 16. Malone JM, Goldstone J, Moore WS, Autogenous profundaplasty: The key to long-term patency in secondary repair of aortofemoral graft occlusion. Ann Surg 1978; 188:81723.
Journal of VASCULAR SURGERY
17. Pearce W, Kempczinski RF. Extended autogenous profundaplasty and aortofemoral grafting: An alternative to synchronous distal bypass. J VASe SURe 1984; 1:455-8. 18. Taylor LM, Baur GM, Eldemiller LR, Porter JM. Extended profimdaplasty. Indications and techniques with results of 46 procedures. Am J Surg 1981; 141:539-42. 19. VoUrath KD, Salles-Cunha SX, Baum P, Bernhard VM, Towne JB. Profimdaplasty follow-up in the vascular laboratory. Bruit 1981; 5:17-21. 20. Rutledge R, Burnham SJ. Profimdaplasty in the ischemic extremity. J Cardiovasc Surg 1983; 24:107-10. 21. Hill DA, Jamieson CW. The results of arterial reconstruction utilizing the profimda femoris artery in the treatment of rest pain and pre-gangrene. Br J Surg 1977; 64:359-61.
The deep femoral artery is the major collateral pathway to the popliteal and distal leg arteries when the superficial femoral artery is obstructed. Previous studies by Strandness 1 and Wright 2 have demonstrated that correction ofstenosis of the deep femoral artery associated with superficial femoral and popliteal artery occlusive disease significantly increases (ower extremity blood flow, which relieves ischemic symptoms. We have previously shown that profundaplasty alone to treat claudication is an efficacious and durable procedure. 3 However, when isolated profundaplasty is performed to provide limb salvage, it has yielded variable results in the healing of ischemic ulcers or necrosis and relief of rest pain. David and Drezner 4 were successful in relieving ischemic symptoms in 86% of their patients whereas Mitchell et alfi had success in only 45%. Several authors have addressed this issue by attempting to define criteria for selection o f patients who will benefit from isolated profundaplasty. Many variables have been considFrom the Department of Surgery,Me&calCollegeof Wisconsin. Reprint requests: David L, Rollins,M.D., Dept. of Surgery,Universlty of Health Sciences/TheChicagoMedical School, 3333 Green Bay Rd., North Chicago, IL 60064.
ered, including arteriographic patterns, extent of disease, segmental pressure measurements, and blood flow assessment during s u r g e r y . 4-6 The purpose of this article is to use both clinical and hcmodynamic criteria to determine the long-term durability of profundaplasty alone performed to effect limb salvage and to identify those patients in whom isolated profundaplasty will be most efficacious. MATERIAL AND METHODS From 1971 to 1980, 54 patients underwent 56 isolated profundaplasties. The group consisted of 41 men and 13 women aged 46 to 97 years (mean 64 years). Sixteen (29%) were diabetic. Prior vascular procedures involving the ipsilateral extremity had been performed in only three patients. The indications for vascular reconstruction were ischemic ulcers, rest pain, or areas of pedal ischemic necrosis. Preoperative studies included biplanar aortobifemoral angiography and, in most cases, segmental Doppler examination. Adequacy of inflow was assessed by palpation of femoral pulses, review of arteriograms, and intraoperative pressure and flow measurements. Preoperative segmental pressure measurements werc available in 31 limbs. The fractional 585
IournNof
VASCULAR SURGERY
586 Rollins et al.
90
Table II. Late results of isolated profiandaplasty in 42 (75%) limbs
80 70
No. of limbs ~ 60 50
...............................
:ilIi .7 ,
40 30 20 I0 0 I
b
I
I
I
L
I
6
12
18
24
36
48
60
MoN s
Profimdaplastypatent Patient without symptoms Distal bypassrequired for limb salvage Profundaplastyoccluded Required inflowprocedure; "redo" profundaplasty for limb salvage Required amputation
22 (53) 6 (14) 3 (7) 11 (26)
*Numbers in parentheses represent percentages.
..-7
Fig. 1. Cumulativc patency and limb rctcntion in 56 limbs undergoing isolated profundaplasty for limb salvage. Table I. Early results (30 days) of isolated profundaplasty in 56 (100%) limbs No. of limbs ~
Profundaplasty patent Limb salvaged Distal bypass required for limb salvage Required amputation
42 (75) 3 (5) 11 (20)
~Numbers in parentheses represent percentages.
pressure decrease across the knee or profundapopliteal collateral index (PPCI) was expressed as follows: above knee pressure - below knee pressure above knee pressure PPCI was measured in these patients and reflected the resistance of the collateral bed. All patients had occlusion or multilevel stenosis of the superficial femoral artery and >50% stenosis of the deep femoral artery. The operative technique consisted of an artcriotomy in the common femoral artery, which was carried distally into thc deep femoral artery beyond the distal extent of the occlusive discase. 7 An endarterectomy was performed if thc luminal surface was ulcerated or irregular. The artcriotomy was closed with a patch of autogenous tissue, usually a segmcnt of endartcrectomized superficial femoral artery, or less frcqucntly, autogcnous vein. For the purposes of analysis, the length of the profundaplasty was divided into short (<2 cm), standard (<8 cm or beyond the laterofemoral circumflex branch to the first perforator), and extended (>8 cm or beyond the first perforator).
The profundaplasty was considered patent if there was an increase in the ankle/brachial index (ABI) of at least 0.1. The repair was considered a failure if the femoral pulse disappeared, if the vessel was anglo I graphically demonstrated to be occluded, or if the ABI returned to preoperative levels. If a subsequent distal bypass was needed to maintain limb salvage, the proftmdaplasty was considered a failure. The patients were followed up for as long as 110 months postoperatively and assessment of the patients' clinical condition and vascular laboratory studies were performed at regular intervals. Graft patency and limb retention were analyzed by the life-table method; perioperative ABI and preoperative PPCI, by Student's t test. RESULTS Postoperative results of the 56 isolated profundaplasties performed are summarized in Table I. The procedure was successful in 42 (75%) patients as evidenced by healing of ischemic ulcers, resolutio~ of rest pain, and healing of areas of ischemic pedal necrosis, either primarily or with ddbridement or minor amputation. Three patients with stenosis of the deep femoral artery and extensive distal occlusive disease required a distal bypass to salvage the extremity. Although the profundaplasty remained patent in all three patients, one required a below-knee amputation (BKA) at 4 months for recurrent ischemia from dbtal graft failure. Eleven limbs (20%) underwent early amputation. The profundaplasty was done in six limbs to lower the level of amputation from above to below the knee. All these patients had extensive areas of pedal necrosis, which necessitated amputation of the foot. The other five early amputations were performed to control persistent gangrene and sepsis and were considered failures of profundaplasty. The late results of the surviving 42 limbs are
Volume 2 Number 4
July1985
Isolated profundaplasty for limb salvage
5 87
£able III. Amputations in diabetic and nondiabetic patients
All limbs (n = 56) Patients with diabetes (n = 16) Patients without diabetes (n = 40)
AICA
BICt
Total
No. (%)
No. (%)
No. (%)
9 (16) 0 (0) 9 (23)
19 (34) 7 (44) 12 (30)
28/56 (50) 7/16 (44)
21/40 (53)
Table IV. Perioperative ABIs in 68 limbs of patients undergoing isolated profundaplasty
Mean preoperative ABI Mean postoperative ABI
All limbs
Amputated limbs
Salvaged limbs
0.37 0.45 (p = NS)
0.27 0.25 (p = NS)
0.42 0.55 (p < 0.0009)
~ o w n in Table II. Twenty-two limbs remained asymptomatic throughout the follow-up period. An additional six limbs had patent profundaplasties but required distal bypass procedures between the second and fifth months to control recurrent ischcmia from progressive atherosclerotic disease. During the follow-up period five of the six distal bypasses occluded, which made amputation necessary. In two of these patients the profundaplasty also occluded. Three late profundaplasty occlusions were successfully treated, which resulted in limb salvage. In two patients progression of proximal occlusive disease required thrombcctomy of the deep femoral artery and inflow procedures, and in one patient recurrent stenosis of the deep femoral artery was treated with patch angioplasty. Eleven amputations were required from 13 to 52 months postoperatively; nine for gangrene and sepsis and two for chronic rest pain caused by ,~rogression of disease. Overall cumulative patency of the deep femoral artery (Fig. 1), calculated by the life-table method, was 49% at 3 years but fell to 21% at 5 years. Similarly cumulative limb salvage was also 49% at 3 years but fell to 36% at 5 years. Twenty-eight amputations were performed (Table III); 20 were done to control septic gangrene and eight for progressive ischemia. The profundaplasty occluded in all nine patients who underwent aboveknee amputation (AKA). Of the 19 patients who underwent BKA 16 (84%) became ambulatory with the use of a prosthesis, including the six who had a planned profundaplasty to salvage the knee joint. There was no significant difference in the number of amputations in the groups with or without diabetes. Twenty-eight limbs had preoperative and postoperative ABI values available for comparison (Table IV). Overall the mean ABI increased by 0.07. How-
ever, in limbs that required eventual amputation, there was actually an average decrease of 0.02. The postoperative ABI was significantly higher in limbs that did not require eventual amputation (p < 0.0009). In 15 of 19 (79%) limbs the ABI increased by more than 0.1. Prcoperative PPCls were calculated in 31 limbs and correlated with the success of profundaplasty determined by the need for amputation (Table V). PPCI <0.19 indicated successful profimdaplasty in 10 o f l l (91%) of limbs. When the PPCI was >0.45, all six limbs required amputation. PPCIs between 0.20 and 0.44 were indeterminate. The results of the operative procedure in relation to clinical presentation were analyzed in all limbs (Table VI). Profimdaplasty was considered successful if it relieved rest pain, healed ischemic ulcers, or healed gangrenous areas primarily or after ddbridement or minor amputation. When only patients with ischemic ulcers were considered, 9 of 17 (53%) healed. One limb ulcer healed initially but the patient required an inflow procedure and "redo" profundaplasty at 34 months. Significant aortoiliac obstruction was overlooked in one patient who required an inflow procedure to control persistent ischemia on the first postoperative day. Six patients in the ischemic ulcer group had early amputations: two AKAs were performed to treat progressive ischemia following profundaplasty occlusion. Four BKAs were required; three to control persistent ischemia or cellulitis, and one was planned to lower the amputation level to below the knee. Only 6 of 19 (32%) patients with rest pain remained without symptoms throughout the followup period. Three others did well after additional distal bypass but 10 ultimately required amputation. In five patients AKA was performed after the profun-
Journal of VASCULAR SURGERY
588 Rollins et al.
Table V. Preoperative PPCI in 31 limbs undergoing isolated profundaplasty PPCI
Limb salvage
Amputation
40.19 (n - 11) 0.20 to 0.44 (n = 14) >0.45 (n = 6)
10 6 0
1 8 6
Table VI. Operative indications and long-term results Success
Failure
Indication
No. of patients (%)
No. of patients (%)
Ischemic ulcer (n = 17) Rest pain (n = i9) Ischemic necrosis (n = 20)
9 (53) 6 (32) 7 (35)
8 (47) 13 (68) 13 (65)
daplasty occluded, and five BKAs were performed in patients with patent profundaplasties. Ischemic necrosis resolved in only 7 of 20 limbs (35%). A minor amputation site healed in one patient following distal bypass but 12 patients required amputation. Ten patients had BKAs; profundaplasty was done to salvage the knee joint in five of these. The profundaplasty had occluded in the two patients who required AKAs. DISCUSSION
Isolated profundaplasty was initially performed to effect limb salvage as an alternative to the early disappointing results of femoropopliteal bypass by Martin et al.8-10 Later it was used as the initial approach to distal ischemia by Modgill et al. n and by Ward and Morris-Jones ~2 and in high-risk patients by Cohn et al.~3 Recent reports have attempted to both determine the efficacy of isolated profundaplasty and develop specific criteria for patient selection. 4-6 When performed to achieve limb salvage, the effectiveness of isolated profundaplasty rapidly d e cays with time. David and Drezner 4 described successful limb salvage in 86% of patients followed up for an average of 19 months, whereas Morris-Jones and Jones 14avoided amputation in only 36% of limbs at 12 months of follow-up. In our study limb salvage was achieved in 57% at 12 months and 52% at 18 months but showed a continued decline to 36% at 5 years. These data emphasize the need for better patient selection and prompted several authors to look at different clinical criteria. Cotton and Roberts ~s and Malone ctal. 16both found diabetes mellitus adversely
influenced patency of the deep femoral artery. In our study, however, there was no significant difference between diabetic (44%) and nondiabetic (53%) patients. The results of the operation in relation to dinical presentation have been extensively investigated. 4,s,ll,lz In general the results of isolated profundaplasty are most successful in patients with nonhealing ischemic ulcers, less successful for rest pain, and the poorest results Occur with ischemic gangrene. These indications form a type of physiologic continuum correlating with increasing vascular resistance and decreasing arterial flow from progressive arterial obstructive disease. The success of profundaplasty is thought to be determined by several factors in addition to stenosis of the deep femoral artery itself.4,12,17,18The most important of these determinants is the adequacy of the profundapopliteal collatero-' system and the severity of tibial arterial occlusive discase. Assessment of obstructive disease based on arteriographic features has bccn stressed by many authors but without uniform findings. Mitchell et al.s reviewed these criteria and reported that arteriography reliably predicts successful profundaplasty when the following conditions exist: (1) minimal occlusive disease of the distal profunda femoris artery, (2) a well-developed profunda femoris collateral system, (3) patent poplitcal artery, and (4) minimal tibial outflow occlusive disease. Hcmodynamic criteria from noninvasive vascular laboratory data have been extensively investigated by numerous researchers. ~-There is a significant increase *References 1, 4, 5, 17-20.
Volume 2 Number 4 July 1985
m the mean postoperative ABI in those patients in whom profundaplasty was successful and a slight decrease in ABI when failure occurred. Wright 2 documented increased limb flow by xenon studies following successful profundaplasty, but neither he nor Morris-Jones and Jones I4 found a change in the perioperative ABI. Our study confirmed a significant mean increase in postoperative ABI in successful profundaplasty. However, ABI only quantified total limb resistance caused by arterial obstruction but did not localize the level of obstruction and was of no predictive value. Segmental pressure measurements, however, can locate and determine the extent of occlusive disease by providing an estimate of the resistance in each collateral bed. Boren et al.6 showed that PPC1 accurately preticts the resistance of the geniculate collateral pathways, which is the most important determinant of profundaplasty success. In our study the PPCI predicted limb salvage in 10 of 11 (91%) limbs when it was ~<0.19. It is interesting that the PPCI correlated well with the operative indications. The mean PPCI was 0.19 in patients with nonhealing ulcers, 0.21 with rest pain, and 0.29 with ischemic gangrene. These data agree with the concept of a physiologic continuum based on increasing vascular obstruction and more severe ischemic derangements. The study of David and Drezner 4 supports this concept, showing that 8 of l l (72%) limbs with gangrene had arteriographic evidence of popliteal occlusion compared with only 10 of 39 (26%) of limbs with rest pain. An additional benefit of profundaplasty noted in this study was the lowering of the major amputation level to below the knee in six patients in whom the extent of pedal tissue necrosis precluded foot salvage. Profundaplasty was performed several days before planned amputation in these patients and all became ambulatory with the use of a prosthesis. Overall 16 of 19 (84%) patients who required BKA were functionally rehabilitated. The concept of the profunda femoris artery as a collateral bed is useful in determining which patients may benefit from this procedure. In this study hemodynamic data provided by determination of the PPCI from segmental limb pressures had significant value. Arteriographic assessment also appears to have prognostic value and its use would complement hemodynamic data in making better patient selection for isolated profundaplasty. Other clinical criteria, such as preoperative ABI or presence of diabetes mel-
Isolated profundaplasty for limb salvage 589
litus, have no predictive value. Clinical presentation may indicate the severity of distal occlusive disease and be a useful determinant as to which reconstructive alternatives should be employed. Profundaplasty alone appears to be efficacious in healing ischemic ulcers and abolishing rest pain but frequently does not heal areas of ischemic gangrene. The postoperative success of profundaplasty may be determined by monitoring the ABI. ABI is usually increased by more than 0.1 in patients who benefit from profundaplasty procedures. Although profundaplasty to achieve limb salvage is effective in only 36% of patients at 5 years, it is an appropriate first procedure in most patients with stenosis of the profunda femoris artery. When simultaneous stenosis of the proftmda femoris artery and femoropopliteal occlusive disease occur, isolated profundaplasty will frequently result in limb salvage. Higher risk distal bypass may be employed later if necessary. In patients who have an occluded distal bypass with poor runoff and concomitant stenosis, isolated profundaplasty often results in limb salvage. In addition, it may provide effective perfusion for preservation of the knee joint. When amputation is inevitable, a BKA usually results in a high degree of functional rehabilitation. REFERENCES 1. Strandness Jr DE. Functional results after revascularization of the profunda femoris artery. Am J Surg 1970; 119: 240-5. 2. Wright CJ. Effect of femoral profi.mdaplasty on blood flow. Can J Surg 1983; 26:328-7. 3. Towne JB, Bernhard VM, Rollins DL, Baum PL. Profundaplasty in perspective: Limitations in the long-term management of limb ischemia. Surgery 1981; 90:1037-46. 4. David TE, Drezner DA. Extended profundaplasty for limb salvage. Surgery 1978; 84:758-63. 5. Mitchell RA, Bone GE, Ridges R, Pomajzi MJ, Fry WJ. Patient selection for isolated profundaplasty. Arteriographic correlates of operative results. Am J Surg 1979; 138:912-9. 6. Boren CH, Towne JB, Bernhard VM, Salles-Cunha S. Profimdapopliteal collateral index. A guide to successful profundaplasty. Arch Surg 1980; 115:1366-72. 7. Bernhard VM, Militello JiM, Geringer AM. Repair of the profimda femoris artery. Am J Surg 1974; 127:676-9. 8. Martin P, Renwick S, Stephenson C. On the surgery of the profunda femoris artery. Br J Surg 1968; 55:539-42. 9. Martin P, Frawley JE, Barabas AP, Rosengarten DS. On the surgery of atherosclerosis of the profimda femoris artery. Surgery 1972; 71:182-9. 10. Martin P, Jamieson C. The rationale for and measurement after profundaplasty. Surg Clin North Am 1974; 54:95-109. 11. Modgill VK, Humphrey CS, Shoesmith JH, Kester RC. The value of profundaplasty in the management of severe femoropopliteal occlusion. Br J Surg 1977; 64:362-4.
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12. Ward AS, Morris-Jones W. The long-term results ofprofundaplasty in femoropopliteal arterial occlusion. Br J Surg 1977; 64:365-7. l& Cohn LH, Trueblood W, Crowley LG. Profunda femoris reconstruction in the treatment of femoropopliteal occlusive disease. Arch Surg 1971; 103:475-9. 14. Morris-Jones W, Jones CDP. Profimdaplasty in the treatment of femoropopliteal occlusion. Am J Surg 1974; 127:680-6. 15. Cotton LT, Roberts VC. Extended deep femoral angioplasty: An alternative to femoropopliteal bypass. Br J Surg 1975; 62:340-3. 16. Malone JM, Goldstone J, Moore WS, Autogenous profundaplasty: The key to long-term patency in secondary repair of aortofemoral graft occlusion. Ann Surg 1978; 188:81723.
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17. Pearce W, Kempczinski RF. Extended autogenous profundaplasty and aortofemoral grafting: An alternative to synchronous distal bypass. J VASe SURe 1984; 1:455-8. 18. Taylor LM, Baur GM, Eldemiller LR, Porter JM. Extended profimdaplasty. Indications and techniques with results of 46 procedures. Am J Surg 1981; 141:539-42. 19. VoUrath KD, Salles-Cunha SX, Baum P, Bernhard VM, Towne JB. Profimdaplasty follow-up in the vascular laboratory. Bruit 1981; 5:17-21. 20. Rutledge R, Burnham SJ. Profimdaplasty in the ischemic extremity. J Cardiovasc Surg 1983; 24:107-10. 21. Hill DA, Jamieson CW. The results of arterial reconstruction utilizing the profimda femoris artery in the treatment of rest pain and pre-gangrene. Br J Surg 1977; 64:359-61.