In the Patient with Profunda Artery Disease, Is Open Revascularization Superior to Endovascular Repair for Improving Rest Pain?


P (patients)

I (intervention)

C (comparator group)

O (outcomes measured)

Patients with limb ischemia secondary to diseased profunda femoris or common femoral artery

Endovascular therapy

Open common femoral endarterectomy and/or profundaplasty

Technical success, primary patency, limb salvage





Results


A critical review of the literature did not provide data for either technique that clearly separated results for patients with rest pain from those with claudication, ulcer or tissue loss. In order to determine the most appropriate procedure for patients with rest pain alone, we have assessed the available published data regarding technical success, safety, immediate hemodynamic and clinical improvement, durability, the need for re-intervention, and limb salvage and with this information attempt to infer the best approach for varying patient circumstances.


Open Surgery: The Gold Standard


The first profundaplasty was performed in 1953 by Norman Freeman, but was not reported until 1961 [11]. Since then, open common femoral endarterectomy with or without profundaplasty has become a well-established approach for restoring the collateral function of the PFA to relieve claudication and limb-threatening ischemia, and to improve the healing potential for a below the knee amputation when limb salvage is not feasible. Success is dependent upon iliac inflow and tibial/pedal run-off as well as the quality of arterial collaterals across the knee. The latter can be estimated by calculating the profunda-popliteal collateral index (PPCI) derived from pre-operative segmental limb pressure measurements using the formula: PPCI = ((AK PressureBK Pressure)/AK Pressure) [12]. An index greater than 0.5 predicts high resistance due to poor collaterals and is a strong indicator of failure, whereas an index of less than 0.25 has been associated with a 67 % success rate [12].

The outcomes for PFA/CFA endarterectomy are presented in Table 16.2. Data from the early 1970s showed that profundaplasty could be performed safely and with good results [24]. Towne et al. [4] presented a series of 237 profundaplasties in 209 patients, 69 (29 %) performed as an isolated procedure and 169 (71 %) in combination with some form of inflow augmentation. Operative mortality was 2 % and immediate technical success was achieved in 99 % of claudicants and 89 % of CLI. The patency rate for claudicants was 77 % at 5 years but only 23 % for CLI, with only an insignificantly lower success for isolated repairs versus those with associated inflow procedures. However, since patency was not assessed by direct visualization in many of the patients, failure may have been the result of progression of disease in the tibial/pedal run off bed rather than the profundaplasty itself. Amputation was required in 43 limbs, all but one in the limb salvage group. All 24 with below-knee amputations had patent profunda repairs whereas the profunda was occluded in 17 of 19 requiring above-knee amputation. Lawson et al. [3] demonstrated a 100 % technical success rate with no perioperative mortality for profundaplasty as a limb salvage procedure. Limb salvage was 87 % and 77 % and patency was 80 % and 60 % at 1- and 2.5-years, respectively. In 1987, Fugger et al. [13] described their experience with profundaplasty as a stand-alone procedure from a prospectively maintained database of 168 patients treated for SFA occlusion. 68 % of patients had clinical improvement, more commonly in those with better tibial runoff and without ischemic ulceration. The limb salvage rate was 68 %, and of those amputated only 41 % were above-knee. More contemporary data has consistently shown good outcomes as well. In 2001 Cardon et al. [18] published their experience with 110 limbs undergoing endarterectomy of the femoral bifurcation for claudication or CLI. Although only 84 % of procedures were technically successful, perioperative mortality was 1 %. Local morbidity was 22 %, but complications were mostly of a minor nature not requiring re-operation. Patency at 3- and 5-years was 95 % and 88 %. Clinical improvement was sustained in 80 % and 71 % of patients over the same intervals. Kang et al. (2008) [21] retrospectively reviewed 58 patients (65 limbs) from their prospectively maintained database who underwent common femoral endarterectomy (CFE). Two-thirds of these patients were claudicants and one-third had CLI. All cases were technically successful. 1-year and 5-year patency was 93 % and 91 % respectively, and there were no amputations. Concomitant endovascular inflow and outflow (hybrid) procedures were performed in 37 (57 %) limbs. Recurrent stenosis occurred in the CFA in only 1 of 28 isolated CFEs but in 4 of 37 of the hybrid procedures. In the same year, Kechagias et al. [23] published a similar retrospective series of CFE, with 15-year follow-up data. Endarterectomy extended into the proximal PFA in 39 % of these patients. Freedom from ipsilateral re-intervention was 68 %, 51 % and 42 % over 5-, 10- and 15-year intervals. However, only one re-intervention was required at the original endarterectomy site. Limb salvage was 94 % at 5 and 10 years, and 85 % at 15 years. Independent predictors of major amputation were current smoking status and critical limb ischemia. Al-Koury et al. [24], Ballotta et al. [26] and Desai et al. [27] have recorded similar results. Each of these studies achieved 100 % technical success with CFE, and primary patency rates of greater than 90 % at up to 7 years [26]. Limb salvage rates were high, 87 % in the Desai study and 100 % in both the Al-Koury and Ballotta series.


Table 16.2
Open common femoral and/or profunda femoris revascularization series















































































































































































Author (year)

N (limbs)

Indication (%CLI) a

Technical success (%)

Primary patency

Limb savage

Peri-op mortality (%)

Complication rate

Towne (1981) [4]

209 (239)

60 %

100

77 % claudication, 23 % CLI (5 years)

80 % IP, 36 % PA (6 years)

2

17 %

Lawson (1983) [3]

11 (15)

100 %

100

80 % (1 year)

87 %

0


Fugger (1987) [13]

163

SFA occlusion

100

96 % (1 month)

68 % (Fontaine III,IV)

8.6


Mukherjee (1989) [14]

29

41 %

100

100 %

100 %

0

0 %

Springhorn (1991) [15]

22 (29)

69 %

96

96 %


0

31 %

Jacobs (1995) [16]

51 (68)

69 %

100

81 % (1 year), 54 % (4 years)

96 %

0

29 %

Hoch (1999) [17]

51 (53)

79 %

100

95 % (1 year), 88 % (3 years)

90 %

3.9

31 %

Cardon (2001) [18]

101 (110)

52 %

84

95 % (3 years), 88 % (5 years)

93 %

1

2.7 %

Nelson (2002) [19]

34

59 %

100

85 % (1 year)

100 %

0

15 %

Salvolainen (2007) [20]

97 (106)

47 %

100


96 %

3.6

9 %

Kang (2008) [21]

58 (65)

32 %

100

93 % (1 year), 91 % (5 years)

100 %

0

9 % (5 % major)

Chang (2008) [22]

171 (193)

54 %

98

97 %

95 %

2.3

22 %

Kechagias (2008) [23]

90 (111)

31 %

100


93 %

1.8

17.1 %

Al-Koury (2009) [24]

95 (105)

35 %

100

100 % (11 month)

95 %

1

7.6 %

Derksen (2009) [25]

140

25 %




0.7

14.3 %

Ballotta (2010) [26]

117 (121)

40 %

100

100 % (1 year), 96 % (7 years)

100 %

0

6.6 %

Desai (2010) [27]

81 (87)

48 %

100

93 % (3 years)

87 %

1

5 %


a CLI ischemic rest pain and/or tissue loss, Fontaine III-IV/Rutherford 4–6; IP inflow and profundaplasty; PA profundaplasty alone; dash (−) denotes no information available

Open surgery to address occlusive disease of the femoral bifurcation has stood the test of time and is both safe and durable. However, less invasive endovascular therapies are being applied with increasing frequency based on concerns regarding tolerance for open surgery in high risk patients, technical difficulties with re-operative groins, operating time, length of hospital stay and local wound complications. In an investigation centered on surgical site infections (SSI) following CFE, Derksen et al. [25] noted a 14 % SSI rate with 75 % of those requiring re-operation. Independent risk factors for development of SSI were re-operative groins and placement of drains at the initial procedure. Although similar incidences of SSI have been reported in other studies, most have been minor problems responding to non-operative therapy [21, 23, 24, 26].


Endovascular Intervention: The Alternative


Angioplasty of the PFA has been performed since the 1970s [28]. The results of this early data noted both clinical and hemodynamic improvement as well as limb salvage in the majority of patients with femoral-popliteal obstruction. Endovascular surgery has advanced significantly since that time, and has become the favored modality for many complex lesions of the lower extremity on the basis of low morbidity, shorter hospital stay and faster recovery [5]. Since outcomes will presumably improve along with rapidly advancing technology, only recent data (since 2000) is included in this review. The relevant studies are summarized in Table 16.3.


Table 16.3
Endovascular CFA/profunda interventions (published series since 2000)
























































Author (Year)

N (limbs)

Location

Indication (%CLI)a

Technical success (%)

Primary patency

Limb savage

Peri-op mortality (%)

Complication rate

Silva (2001) [29]

31 (32)

PFA

59

94

90 % (34 months)

94 % (34 months)

3

9 %

Stricker (2004) [30]

27 (33)

CFA/PFA

18

100

87 % (1 year)

96 % (30 month)

0

0 %

Silva (2004) [31]

20 (21)

CFA

43

100

90 % (1 year)

90 % (1 year)

5

0 %

Dick (2006) [32]

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Oct 11, 2017 | Posted by in CARDIOLOGY | Comments Off on In the Patient with Profunda Artery Disease, Is Open Revascularization Superior to Endovascular Repair for Improving Rest Pain?

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