Clinical Outcome of Surgical Endarterectomy for Common Femoral Artery Occlusive Disease

Transcription

1 964 KUMA S et al. Circulation Journal ORIGINAL ARTICLE Official Journal of the Japanese Circulation Society Peripheral Vascular Disease Clinical Outcome of Surgical Endarterectomy for Common Femoral Artery Occlusive Disease Sosei Kuma, MD, PhD; Kiyoshi Tanaka, MD, PhD; Takahiro Ohmine, MD, PhD; Koichi Morisaki, MD, PhD; Akio Kodama, MD, PhD; Atsushi Guntani, MD, PhD; Masaru Ishida, MD, PhD; Jin Okazaki, MD, PhD; Shinsuke Mii, MD, PhD Background: Although common femoral artery endarterectomy (CFE) is the standard treatment for occlusive disease of the common femoral artery (CFA), several studies have noted encouraging results for endovascular therapy in this anatomical area. Methods and Results: A retrospective multi-center study of 118 consecutive limbs from 111 symptomatic patients undergoing CFE between April 1998 and December 2014 was performed. Seventy-five CFE were performed on limbs for intermittent claudication and 43 CFE were performed for critical limb ischemia (CLI). The prevalence of perioperative complications was higher in patients with CLI than in the claudication patients. The technical success rate was 99% in all cases. The 1- and 5-year primary patency rates were 100% and 100% for claudication and 95% and 95% for CLI, respectively. The assisted-primary patency rates were 100% at both time points in both groups. Freedom from major amputation at 1 and 5 years was 100% and 100% in the claudication patients and 93% and 82% in the CLI patients, respectively. The 1- and 5-year overall survival rates were 97% and 89% in the claudication patients and 69% and 33% in the CLI patients, respectively. Conclusions: CFE is a safe, effective and durable procedure for occlusive disease of the CFA. This procedure should remain the standard treatment for this anatomical region. (Circ J 2016; 80: ) Key Words: Common femoral artery; Endarterectomy; Peripheral artery disease Isolated occlusive disease of the common femoral artery (CFA) is uncommon and tends to often be associated with aorto-iliac or femoro-popliteal atherosclerosis. 1 The plaques in the region are often bulky, eccentric and highly calcified, and can be complex due to the involvement of the femoral bifurcation. Moreover, the CFA is important as an access site to various endovascular procedures and a strategic region that carries the aorto-iliac artery, femoro-popliteal artery and their collaterals. Although surgical endarterectomy has been performed as the standard treatment in this area, 2 10 several studies have shown encouraging results for endovascular therapy (EVT) in occlusive disease of the CFA Conversely, EVT has been contraindicated for disease of the CFA due to various problems. Although CFA stenting might improve the short-term success, it can result in long-term complications: theoretical risk of stent fracture, intimal hyperplasia, sacrifice of the deep femoral artery (DFA), or preclusion from the CFA puncture. Common femoral artery endarterectomy (CFE) has been reported to have a high initial success rate, low mortality, and high patency rate, 2 10 but its success cannot be concluded from the current reports. The purpose of this study was therefore to review our experience of treating peripheral artery disease using CFE and to examine the safety and efficacy of CFE. Methods A retrospective, multi-center study was performed to investigate the clinical results of CFE. The study included all consecutive adult patients who underwent elective CFE. Patients who had undergone previous CFE or previous or concurrent bypass grafts utilizing the CFA for either proximal or distal Received November 10, 2015; revised manuscript received January 5, 2016; accepted January 25, 2016; released online February 19, 2016 Time for primary review: 34 days Department of Vascular Surgery, Fukuoka Higashi Medical Center, Koga (S.K.); Department of Vascular Surgery, Kokura Memorial Hospital, Kitakyushu (S.K., K.T., K.M., A.K., A.G., M.I., J.O., S.M.); Department of Vascular Surgery, Steel Memorial Yawata Hospital, Kitakyushu (K.T., T.O., S.M.); Department of Surgery, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, Hiroshima (T.O.); Department of Vascular Surgery, Matsuyama Red Cross Hospital, Matsuyama (K.M.); Division of Vascular Surgery, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya (A.K.), and Department of Vascular Surgery, Saiseikai Yahata General Hospital, Kitakyushu (A.G., S.M.) Japan Mailing address: Sosei Kuma, MD, PhD, Department of Vascular Surgery, Fukuoka Higashi Medical Center, Chidori, Koga , Japan. kumasosei@yahoo.co.jp ISSN doi: /circj.CJ All rights are reserved to the Japanese Circulation Society. For permissions, please cj@j-circ.or.jp

2 Clinical Outcome of CFE 965 Table 1. Patient Demographics Variable Claudication (n=75) n or mean CLI (n=43) n or mean P-value Age (years) Male 60 (80) 28 (65) Comorbidity Hypertension 65 (87) 35 (81) Diabetes 39 (52) 27 (63) Dyslipidemia 33 (44) 13 (30) CAD 37 (49) 25 (58) CKD (Cre>1.5) 19 (25) 23 (53) * ESRF 9 (12) 22 (51) <0.0001* COPD 3 (4) 2 (5) Smoking history 37 (49) 14 (33) Cerebrovascular disease 20 (27) 14 (33) Rutherford class 3 75 (100) 0 (0) 4 0 (0) 18 (42) 5 0 (0) 22 (51) 6 0 (0) 3 (7) <0.0001* *P<0.05. CAD, coronary artery disease; CKD, chronic kidney disease; CLI, critical limb ischemia; COPD, chronic obstructive pulmonary disease; ESRF, end-stage renal failure. anastomosis were excluded. Additionally, any emergency patients with acute limb ischemia were excluded. The primary endpoints were primary and assisted-primary patency, and the secondary endpoints were postoperative complications, overall survival and freedom from major amputation. Between April 1998 and December 2014, 118 CFE were performed on 111 symptomatic patients with occlusive disease of the CFA at Kokura Memorial Hospital and Steel Memorial Yawata Hospital, Kitakyushu, Fukuoka, Japan. CFE was performed using the standard technique. The CFA was exposed and mobilized along its entire length with the distal extent of the dissection determined by individual anatomy. Under systemic heparinization, longitudinal arteriotomy was carried out extending from slightly proximal to the disease to the origin of the superficial femoral artery (SFA), and was extended to the SFA and/or DFA when occlusive disease was extended. Dissection of the occluding plaque was performed through an adequate cleavage plane and orificial and extraction endarterectomy without inspection was not performed. The proximal and distal ends were sharply transected, and the distal end of the intima was reattached with interrupted sutures, except in the case of severe calcification due to difficulty of suturing, and lower risk of intimal flap. Patch angioplasty was then performed using a vein graft or polytetrafluoroethylene, but arteriotomy was directly sutured when it was limited to the CFA and judged to be of sufficient caliber. All procedures were performed in an operating room suite with fixed or mobile imaging. For the hybrid procedures, CFE was performed prior to the endovascular component. Following CFE, access was obtained through the patch under direct vision in the ipsilateral limb and endovascular procedures were carried out. All patients were routinely evaluated 1 month after the procedure by the surgeons, along with lower extremity noninvasive studies using ankle-brachial index and duplex ultrasound. On duplex ultrasound, peak systolic velocity >300 cm/s was considered to indicate stenosis. The patients were then followed up every 3 6 months according to the discretion of the treating surgeon. Further interventions were then carried out at the discretion of the vascular surgeon. Patients who were lost to follow-up were contacted by telephone by the surgeon and the appropriate data were gathered. Statistical Analysis Statistical analysis was carried out using JMP 10 (SAS Institute, Cary, NC, USA), with Fisher s exact test for categorical variables and Student s t-test for continuous variables. Data are expressed as mean ± SD. Survival or event-free curves were estimated using the Kaplan-Meier method and compared using log-rank test. P<0.05 was considered to be statistically significant. Results A total of 118 CFE were performed on 111 symptomatic patients with occlusive disease of the CFA: 75 CFE were performed on limbs for intermittent claudication and 43 CFE were performed for critical limb ischemia (CLI). Table 1 summarizes the demographics and cardiovascular risk factors of each group, which were typical for patients with atherosclerotic disease. The prevalence of chronic kidney disease and endstage renal failure (ESRF) was higher in the CLI group than in the claudication group. There were no statistically significant differences between the 2 groups for any other demographic characteristics. Table 2 summarizes the operative procedures for each group. Although most CFE were performed under general anesthesia, the prevalence of local anesthesia and regional block were higher in the CLI group than in the claudication group due to poor general patient condition. There were no statistically significant differences between the claudication and CLI patients regarding lesional characteristics, CFE procedures, combined procedures, operation time or blood loss. The perioperative adverse events are summarized in Table 3. Although perioperative mortality was not statistically different between the groups (P=0.0596), 2 patients in the CLI group died on postoperative days 21 and 27: 1 died due to sepsis of

3 966 KUMA S et al. Table 2. Procedures Variable Claudication (n=75) n or mean CLI (n=43) n or mean P-value Anesthesia General 65 (87) 32 (74) Epidural/Spinal 7 (9) 2 (5) Regional nerve block 3 (4) 7 (16) Local 0 (0) 2 (5) * Lesion location CFA alone 53 (71) 26 (60) CFA and SFA 15 (20) 9 (21) CFA and DFA 6 (8) 6 (14) CFA, SFA and DFA 1 (1) 2 (5) CFE procedure Direct suture 6 (8) 5 (12) Patch angioplasty Vein patch 67 (89) 33 (77) eptfe patch 2 (3) 5 (12) Combined procedures Iliac EVT 9 (12) 3 (7) SFA EVT 7 (9) 3 (7) SFA TEA 1 (1) 0 (0) Popliteal TEA 1 (1) 1 (2) Infragenicular bypass 1 (1) 2 (5) Infragenicular EVT 0 (0) 3 (7) Operation time (min) Blood loss (ml) *P<0.05. CFA, common femoral artery; DFA, deep femoral artery; eptfe, expanded polytetrafluoroethylene; EVT, endovascular therapy; SFA, superficial femoral artery; TEA, thromboendarterectomy. Other abbreviation as in Table 1. Table 3. Postoperative Complications Variable Claudication (n=75) n CLI (n=43) n P-value Perioperative death 0 (0) 2 (5) Complications 6 (8) 13 (30) * Wound complication 5 (7) 4 (9) Bleeding 0 (0) 2 (5) Cardiac 0 (0) 2 (5) Neurological 1 (1) 0 (0) Remote infection 0 (0) 7 (16) * *P<0.05. Abbreviation as in Table 1. unknown etiology and the other due to pneumonia and heart failure. The prevalence of perioperative complications, especially remote infections, including pneumonia, urinary tract infection and sepsis, was higher in the CLI group than in the claudication group. Although most frequent events were wound complications, including lymphorrhea and wound infection, none of the patients require surgical management. Bleeding occurred from the arterial suture line in 2 CLI patients: 1 patient underwent repair with additional sutures on postoperative day 0, but the other patient underwent repeated patch angioplasty with expanded polytetrafluoroethylene on postoperative day 1 due to rupture of the vein patch. No other revisions were required for any patient within 30 days, and the initial success rate was 99% in all cases. Rest pain disappeared in all CLI patients except 1 patient: in that patient with poor- controlled foot infection, below-the-knee amputation was carried out on postoperative day 14. On further surveillance, 1 patient with CLI had restenosis, which was corrected with cutting balloon angioplasty 5 months after the initial operation. With a mean follow-up period of 33 months (range, months), the 1- and 5-year primary patency rates were 100% and 100% in the claudication patients, and 95% and 95% in the CLI patients, respectively (P=0.0472) (Figure 1). The primary-assisted patency rates were 100% at both time points in both groups. Among 25 patients with ulcer or gangrene, complete healing of the wounds was achieved within 3 months postoperatively in 22 patients. Despite the patency of CFE, however, 5 limbs were unsalvageable due to incomplete reduction of foot ischemia and the patients poor general condition (Figure 2). Accordingly, freedom from major amputation at 1

4 Clinical Outcome of CFE 967 Figure 1. Primary patency rate: red line, claudication patients; blue line, critical limb ischemia (CLI) patients. Figure 2. Limb salvage rate: red line, claudication patients; blue line, critical limb ischemia (CLI) patients. and 5 years was 100% and 100% in the claudication patients and 93% and 82% in the CLI patients, respectively (P=0.0110). The 1- and 5-year overall survival rates were 97% and 89% in the claudication patients and 69% and 33% in the CLI patients, respectively (P<0.0001) (Figure 3). Discussion Surgical endarterectomy has been the standard treatment for occlusive disease of the CFA for more than 50 years. Previous studies of CFE are listed in Table The Malgor et al study is the largest to date, 9 and most of the studies included <100 patients; the present study is the third largest study to date. In the previous studies, CFE had a high initial success rate of %, % primary patency, and % assistedprimary patency, and the present results are in line with these. In the present cohort, 36% had CLI and 26% had ESRF. Because 2 patients with CLI required revision, the primary patency rate was significantly lower in the CLI patients than in the claudication patients (95% vs. 100%, P<0.05). All patients, however, achieved assisted-primary patency. Therefore, in the present study, CFE was effective for revascularization even in CLI and ESRF patients. Despite the perfect rate of assisted-primary patency, however, freedom from major

5 968 KUMA S et al. Figure 3. Overall survival rate: red line, claudication patients; blue line, critical limb ischemia (CLI) patients. Table 4. Reports on CFE First author (year) No. patients CLI ESRF Mortality Mukherjee (1989) ND ND Hoch (1999) ND ND ND Nelson (2002) ND Kang (2008) ND Kechagias (2008) ND ND ND 94 Al-Khoury (2009) ND Ballotta (2010) ND Malgor (2012) 9 (A) ND (B) ND Nishibe (2015) Present study One-year follow-up; 4-year follow-up. (A) CFE alone; (B) CFE with distal bypass. APP, assisted-primary patency rate at 5 years; CFE, common femoral artery endarterectomy; LS, limb salvage rate at 5 years; ND, not described; PP, primary patency rate at 5 years; TS, technical success. Other abbreviations as in Table 1. TS PP APP LS amputation at 1 and 5 years was 93% and 82% in the CLI patients. CLI patients often have multi-level arterial occlusive disease, especially below-the-knee occlusive disease. 18 Patients with tissue loss or gangrene should undergo complete revascularization to the ankle as permitted by the patient s condition, although patients with claudication or rest pain might undergo CFE alone. Although patients with CFA lesions and skipped SFA or below-the-knee lesions underwent CFE and combined procedures, the patients with complex lesions on CFA to SFA underwent CFE with a femoro-popliteal or femoro-tibial bypass. Although iliac or femoro-popliteal occlusive disease could be adequately treated by EVT or surgery, belowthe-knee occlusive disease occasionally cannot, due to general or anatomic conditions. In the current study, 5 patients with complicated comorbidities including ESRF (80%), ischemic heart disease (100%), and cerebrovascular disease (80%) required major amputation because of the progression of ischemia due to BTK lesions and/or infection; 3 patients underwent subsequent EVT for their BTK lesions. Recently, Siracuse et al investigated a total of 1,513 patients undergoing elective CFE, and found that 30-day postoperative mortality was 1.5%. 19 Postoperative morbidities included cardiac (1.0%), pulmonary (1.9%), renal (0.4%), urinary tract infection (1.7%), thromboembolic (0.5%), neurologic (0.4%), sepsis (2.7%), superficial (6.3%), and deep surgical site complications (2.0%); at least 1 complication, including major or minor, was seen in 7.9% of the patients. There were 2 perioperative deaths in the present study: 1.7% in the overall group and 4.7% in the CLI groups. At least 1 complication, including major or minor, was seen in 8% of the claudication patients and in 30% of CLI patients, respectively (P=0.0006). Two patients in the CLI group had to return to the operating room

6 Clinical Outcome of CFE 969 due to bleeding, whereas no claudication patients had to do so. This indicates that the CLI patients could have an increased risk of mortality and morbidity, which may be due to the increased operation time (P=0.0930) and blood loss (P=0.0504). Recently, the popularity of EVT has spread due to the associated lower morbidity and mortality rates, shorter hospital stay, and quicker recovery to normal functional status compared with surgical revascularization. 20,21 EVT for the CFA, however, has been abandoned due to its unique characteristics: CFA lesions are too bulky and highly calcified to treat with balloon angioplasty, and surgeons hesitate to implant the stent because of the theoretical risk of stent fracture, sacrifice of DFA or preclusion from the CFA puncture. Frequently, restenosis appears following EVT for the CFA: the 1-year restenosis rate is 15 28% Bonvini et al noted that in 360 CFA lesions treated by balloon angioplasty and provisional stenting (37%), restenosis and target lesion revascularization (TLR) at 12 months were seen in 27.6% and 19.9% of patients, respectively, 14 which was disappointingly similar to the previous results. A randomized trial by Linni et al compared non-coated bioabsorbable stent implantation (BASI) and CFE for CFA lesions, and the primary and secondary patency rates were 80% vs. 100% and 84% vs. 100% for BASI and CFE patients at 1 year, respectively. 16 Recently, Thiney et al reported that, at a mean follow-up of 24 months, the rates of restenosis, TLR, and stent fracture were 7%, 4% and 9%, respectively, in 53 CFA lesions treated with EVT including 50 that underwent primary stenting. 15 CFA stenting might decrease the rate of restenosis and TLR, but it does not necessarily deliver long-term patency because stent fractures may increase over time. Reocclusion of the CFA and its bifurcation can cause severe limb ischemia. Indeed, the major amputation rate of claudication and CLI groups was 3% and 13%, respectively. 15 Furthermore, CFA stenting can cause potential complications for subsequent surgical conversion: stent implantation means that subsequent surgery requires longer dissection and arteriotomy, and more complicated procedures for processing the CFA branches. There are few reports on the long-term results of EVT for the CFA; Soga et al reported that the 1- and 5- year primary patency rates were 73.5% and 46.9% in 111 CFA lesions treated with EVT, 17 which is not promising. The main limitations associated with this study were the relatively small cohort size and the lack of a control group or randomization. The patient population, anatomic features, and treatment options were heterogeneous. Conclusions CFE is an effective and durable procedure for treating occlusive disease of the CFA. This procedure should remain the standard treatment of this anatomical region. A less invasive therapy, however, might be considered for CLI patients given the increased mortality and morbidity observed in this patient group. Acknowledgments The authors thank Dr Brian Quinn, Japan Medical Communication, Fukuoka for providing critical comments regarding the manuscript. None. Name of Grant References 1. Johnston KW, Rae M, Hogg-Johnston SA, Colapinto RF, Walker PM, Baird RJ, et al. Five-year results of a prospective study of percutaneous transluminal angioplasty. Ann Surg 1987; 206: Mukherjee D, Inahara T. Endarterectomy as the procedure of choice for atherosclerotic occlusive lesions of the common femoral artery. Am J Surg 1989; 157: Hoch JR, Turnipseed WD, Acher CW. Evaluation of common femoral endarterectomy for the management of focal atherosclerotic disease. Vasc Endovasc Surg 1999; 33: Nelson PR, Powell RJ, Schermerhorn ML, Fillinger MF, Zwolak RM, Walsh DB, et al. Early results of external iliac artery stenting combined with common femoral artery endarterectomy. J Vasc Surg 2002; 35: Kang JL, Patel VI, Conrad MF, LaMuraglia GM, Chung TK, Cambria RP. Common femoral artery occlusive disease: Contemporary results following surgical endarterectomy. J Vasc Surg 2008; 48: Kechagias A, Ylönen K, Biancari F. Long-term outcome after isolated endarterectomy of the femoral bifurcation. World J Surg 2008; 32: Al-Khoury G, Marone L, Chaer R, Rhee R, Cho J, Leers S, et al. Isolated femoral endarterectomy: Impact of SFA TASC classification on recurrence of symptoms and need for additional intervention. J Vasc Surg 2009; 50: Ballotta E, Gruppo M, Mazzalai F, Da Giau G. Common femoral artery endarterectomy for occlusive disease: An 8-year single-center prospective study. Surgery 2010; 147: Malgor RD, Ricotta JJ 2nd, Bower TC, Oderich GS, Kalra M, Duncan AA, et al. Common femoral artery endarterectomy for lower-extremity ischemia: Evaluating the need for additional distal limb revascularization. Ann Vasc Surg 2012; 26: Nishibe T, Maruno K, Iwahori A, Fujiyoshi T, Suzuki S, Takahashi S, et al. The role of common femoral artery endarterectomy in the endovascular era. Ann Vasc Surg 2015; 29: Stricker H, Jacomella V. Stent-assisted angioplasty at the level of the common femoral artery bifurcation: Midterm outcomes. J Endovasc Ther 2004; 11: Azéma L, Davaine JM, Guyomarch B, Chaillou P, Costargent A, Patra P, et al. Endovascular repair of common femoral artery and concomitant arterial lesions. Eur J Vasc Endovasc Surg 2011; 41: Baumann F, Ruch M, Willenberg T, Dick F, Do DD, Keo HH, et al. Endovascular treatment of common femoral artery obstructions. J Vasc Surg 2011; 53: Bonvini RF, Rastan A, Sixt S, Noory E, Schwarz T, Frank U, et al. Endovascular treatment of common femoral artery disease: Mediumterm outcomes of 360 consecutive procedures. J Am Coll Cardiol 2011; 58: Thiney PO, Millon A, Boudjelit T, Della Schiava N, Feugier P, Lermusiaux P. Angioplasty of the common femoral artery and its bifurcation. Ann Vasc Surg 2015; 29: Linni K, Ugurluoglu A, Hitzl W, Aspalter M, Hölzenbein T. Bioabsorbable stent implantation vs. common femoral artery endarterectomy: Early results of a randomized trial. J Endovasc Ther 2014; 21: Soga Y, Mii S, Aihara H, Okazaki J, Kuma S, Yamaoka T, et al. Comparison of clinical outcome after bypass surgery vs. endovascular therapy for infrainguinal artery disease in patients with critical limb ischemia. Circ J 2013; 77: Soga Y, Tomoi Y, Sato K, Iida O, Yokoi H. Clinical outcome after endovascular treatment for isolated common femoral and popliteal artery disease. Cardiovasc Interv Ther 2013; 28: Siracuse JJ, Gill HL, Schneider DB, Graham AR, Connolly PH, Jones DW, et al. Assessing the perioperative safety of common femoral endarterectomy in the endovascular era. Vasc Endovasc Surg 2014; 48: Kobayashi N, Hirano K, Nakano M, Muramatsu T, Tsukahara R, Ito Y, et al. Wound healing and wound location in critical limb ischemia following endovascular treatment. Circ J 2014; 78: Aihara H, Soga Y, Mii S, Okazaki J, Yamaoka T, Kamoi D, et al. Comparison of long-term outcome after endovascular therapy versus bypass surgery in claudication patients with Trans-Atlantic Inter- Society Consensus-II C and D femoropopliteal disease. Circ J 2014; 78: