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ORIGINAL ARTICLE
Year : 2020  |  Volume : 7  |  Issue : 2  |  Page : 136-140

Comparison of outcome of various modalities in trans-atlantic inter-society consensus d femoropopliteal disease


1 Department of Vascular Surgey, Army Hospital (Research and Referral), New Delhi, India
2 Department of Vascular and Endovascular Surgery, Army Hospital (Research and Referral), New Delhi, India

Date of Submission14-Sep-2019
Date of Acceptance21-Oct-2019
Date of Web Publication17-Jun-2020

Correspondence Address:
Dr. Rishi Dhillan
Department of Vascular and Endovascular Surgery, Army Hospital (Research and Referral), New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijves.ijves_66_19

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  Abstract 


Background: This study aimed to assess the role of various modalities of treatment for trans-atlantic inter-society consensus document (TASC D) femoropopliteal disease. Methods: This was a retrospective and prospective study from January 2015 to December 2018; 153 patients who were admitted at Army Hospital Research and Referral with TASC D femoropopliteal disease and underwent hybrid procedure, endovascular or open surgery were included in the study. Results: 58.8% (90/153) patients underwent femoropopliteal bypass. 27.4% (42/153) patients underwent the hybrid procedure and 13.72% (21/153) patients underwent endovascular procedure. The primary patency rate of open surgery at 1 year is 85.6%, hybrid procedure (iliac stenting and fem-pop bypass is 78.9%, transfemoral thrombectomy and balloon angioplasty is 91.2%), endovascular procedure (primary superficial femoral artery drug-eluting balloon angioplasty is 94.4%, atherectomy is 70.3%). Secondary patency rate of open surgery and hybrid procedure was 94.6%, endovascular surgery was 50%. There was no significant difference in limb salvage rate in all three groups. Acute coronary syndrome occurred in 4% of patients in open femoro-popliteal bypass group, 5% patients in the endovascular group, 3.8% in the hybrid group. Cerebro-vascular accident (CVA) in 1.5% patients open fem-pop group and 1.5% patients in the endovascular group in follow-up period. Conclusion: Although open revascularization remains the treatment of choice for advanced atherosclerotic diseases involving femoropopliteal segment (TASC D), endovascular and hybrid procedures are not inferior to open surgery. There is a role for hybrid procedures as they augment the technical success rate of pure endovascular interventions for complex TASC D femoropopliteal lesion. Hybrid procedures can be an alternative in patients with multiple comorbidities giving equal short-term results and decreased morbidity.

Keywords: Acute coronary syndrome, angioplasty, atherectomy, comorbidity, endovascular procedures, femoral artery, limb salvage, prospective studies, retrospective studies, thrombectomy


How to cite this article:
Kumar AK, Anand V, Dhillan R, Patra V, Swain P, Tripathy G N. Comparison of outcome of various modalities in trans-atlantic inter-society consensus d femoropopliteal disease. Indian J Vasc Endovasc Surg 2020;7:136-40

How to cite this URL:
Kumar AK, Anand V, Dhillan R, Patra V, Swain P, Tripathy G N. Comparison of outcome of various modalities in trans-atlantic inter-society consensus d femoropopliteal disease. Indian J Vasc Endovasc Surg [serial online] 2020 [cited 2020 Jul 6];7:136-40. Available from: http://www.indjvascsurg.org/text.asp?2020/7/2/136/286911




  Introduction Top


Peripheral arterial disease (PAD) is a common manifestation of atherosclerosis and is defined as any pathologic process obstructing blood flow in the arteries, excluding coronary and cerebral vascular beds.[1] Less than 20% of patients with PAD have typical symptoms of intermittent claudication – leg pain relieved by rest, critical limb ischemia – ulcer/gangrene.[2] The trans-Atlantic Inter-Society Consensus II (TASC II) guidelines recommend endovascular revascularization for Type A lesions and surgery for Type D lesions, whereas endovascular treatment is preferred for Type B lesions and surgery for good-risk patients with Type C lesions.[3] This study aimed to assess the role of various modalities of treatment for TASC D femoropopliteal disease.


  Methods Top


The research was conducted after receiving approval from the Institutional Research Committee and Institutional Ethical Committee. Written informed consent was obtained from all the patients before their enrolment in the research study. This was a single-center retrospective and prospective observational study conducted in the Department of Vascular and Endovascular Surgery, Army Hospital (R and R), Delhi.

All patients admitted at this center with femoropopliteal disease TASC D lesion were included in this study. The medical records of patients admitted from January 2015 to December 2018 were collected. All patients were evaluated with clinical signs, Ankle Brachial Index (ABI), comorbidities, hematological and biochemical parameters, two-dimensional echocardiography and where indicated coronary angiography. Imaging was done using computed tomography angiogram, while chronic kidney disease patients were evaluated using color Doppler and/or magnetic resonance angiography. Although the existing guidelines dictate that patients with TASC D lesion should be offered open surgery, patients who were unfit for anesthesia due to coexisting comorbidities were treated with endovascular and hybrid options.

Patients were prospectively followed for major adverse clinical events. All the patients were followed up for 1 year for subjective and objective-improvement/worsening of the clinical condition. All patients underwent a clinical examination, ABI measurement and duplex scan at 1, 3, 6 months, and 1 year.

Primary patency was defined as patency during the interval between primary intervention and repeated intervention.

Secondary patency was defined as patency that has been restored after occlusion of the treated arterial segment.

Inclusion criteria

All patients presenting with chronic limb ischemia (femoropopliteal disease - TASC D) were included.

Exclusion criteria

Patients with acute limb ischemia without preexisting chronic limb ischemia were excluded.

Statistical analysis

Independent Student's t-test was used for comparison of quantitative parameters. Crosstables were generated, and the Chi-square test was used for testing of associations. Value of P < 0.05 was considered statistically significant and the SPSS V22.0 (IBM, Armonk, New York, USA) software used for the analysis.


  Results Top


A total of 153 patients with TASC D lesion were included in the study [Figure 1]. Patients were divided into the three groups, Group A – open surgery (femoropopliteal bypass), Group B – hybrid procedure (Iliac stenting and femoropopliteal bypass, transfemoral thrombectomy and balloon angioplasty of superficial femoral artery [SFA]), and Group C – endovascular procedure (primary SFA drug-eluting balloon [DEB] angioplasty, atherectomy).
Figure 1: Computed tomography angio-trans-Atlantic inter-society consensus D lesion femoropopliteal disease

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About 58.8% (90/153) patients underwent femoropopliteal bypass [Figure 2] of which in 22 patients reverse saphenous venous graft (RSVG) was used, whereas in 68 patients, polytetrafluoroethylene (PTFE) graft was used. 27.4% (42/153) patients underwent a hybrid procedure [Figure 3]. 13.72% (21/153) patients underwent endovascular surgery. The number of procedures done in each group are given in [Figure 4].
Figure 2: Femoro-popliteal bypass grafting with PTFE graft

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Figure 3: Post-iliac stenting image

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Figure 4: Number of procedure done in each group

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Primary patency rate at 1 year: For fem-pop bypass PTFE graft was 84.9% and for RSVG graft was 85.7%. In hybrid procedures, iliac stenting and fem-pop bypass was 78.9%, while transfemoral thrombectomy and balloon angioplasty was 91.2%. For the endovascular procedures, primary SFA DEB angioplasty was 94.4% while atherectomy was 70.3%. The secondary patency rate of open surgery was 94.6% and hybrid procedure was 80.6%, endovascular surgery was 50%.

Twenty-three patients underwent major amputation (11 in Group A, 6 each in Group B and C) [Figure 5].
Figure 5: Number of major amputation in each treatment group

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The procedure-related complications included 13 cases of thigh hematoma, 5 cases of common femoral artery (CFA) pseudoaneurysm postendovascular procedure, 1 retroperitoneal bleed post-iliac stenting, and 14 cases of thrombosis of PTFE graft in immediate postoperative period managed with graft thrombectomy and 8 cases of graft infection [Table 1].
Table 1: Complications n=153

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Systemic complications included acute coronary syndrome, which occurred in 4% patients in Group A, 3.8% patients in Group B, and 5% in Group C. Cerebro-vascular accident (CVA) occurred in 1.5% patients in Group A and Group B.


  Discussion Top


The TASC II consensus recommends endovascular revascularization for Type A lesions and surgery for Type D lesions, whereas endovascular treatment is preferred for type B lesions and surgery for good-risk patients with Type C lesions.

In hybrid procedures – endovascular surgery and open surgery are combined, particularly in TASC D lesion, where we can avoid long incisions, especially abdominal incision on high-risk patients and still achieve similar limb salvage with minimum mortality and morbidity.

Dosluoglu et al.[4] did a retrospective and prospective study from 2001 to 2008 included 654 patients, 770 limbs (67% critical limb ischemia), 226 (29%) had open, 436 (57%) had endovascular (EV), and 108 (14%) had hybrid procedures simple hybrid (sHYBRID) for TASC A/B lesion, complex hybrid c HYBRID) for TASC C/D lesion (56 sHYBRID, 52 cHYBRID). Thirty-day myocardial infarction/death rate was significantly higher in the HYBRID than the EV group, with no difference within the HYBRID group. The patency rates were similar in the sHYBRID and cHYBRID groups and comparable to the endovascular and open treated patients with similar disease complexity. Limb salvage in patients who presented with critical limb ischemia was better in the cHYBRID group than other groups. Overall survival was similar in all groups.

Zhou et al.[5] did a case series study with retrospective analysis of prospectively collected nonrandomized data between 2008 and 2012, 43 underwent the hybrid procedure. Hybrid patients had less overall perioperative morbidity (12% vs. 28%; P = 0.042) compared with OPEN patients. No statistically significant difference in 36 months in the primary, assisted primary or secondary patency was seen between the two groups. Limb salvage rates of HYBRID versus OPEN at 3 years were similar (76.3% ± 9.3% vs. 80.4% ± 8.2%; P = 0.579). The study done by Dosluoglu et al. is one of the largest studies on hybrid revascularization found that 15% were complex hybrid procedures where both iliac and fem-pop segments were targeted. In our study, 50% of our cases were complex hybrid procedures, femoral endarterectomy was done in 8/42 patients and it helps as an interim station in long hybrid revascularizations and also improves profunda runoff. In our study, primary patency rate at 1 year for iliac stenting and fem-pop bypass (hybrid procedure) was 78.9% which is similar to the results in study done by Zhou et al. This low patency rate might be due to the presence of infragenicular disease (poor outflow) and critical limb ischemia. Whereas the primary patency rate of trans femoral thrombectomy and DEB angioplasty of SFA (HYBRID) was 91.2%, this procedure was done for acute on chronic limb ischemia in which the thrombectomy unmasked the underlying lesions which were <50% diameter short segment residual lesions; hence, DEB angioplasty was done. This allows a stent free arterial segment which can be utilized when necessary.

In our study, we found that the primary patency rate at 1 year for fem-pop bypass PTFE graft is 84.9% and RSVG graft is 85.7%, which is similar to the studies done by Veith et al.[6] (69% vs. 50%), Klinkert et al.[7] (84% vs. 79%), AbuRahma et al.[8] (76% vs. 68%). The higher patency rates are likely to be due to the lesser duration of follow-up compared to other studies.

In our study, we could not assess the primary assisted patency because we get patients from all over India from remote places so they mostly present to us with primarily occluded graft. The secondary patency rate of PTFE bypass was 94.6% at 1 year which is comparable with other studies. At our institute, we follow the principle of using PTFE graft for above-knee femoropopliteal bypass and vein is preserved, as it reduces the duration of operation, preserves the saphenous vein for future use, reduces recovery time, duration of hospital stay, and ease of secondary interventions.

At our center, we do endovascular treatment for TASC A, B and C lesions except few cases of TASC C lesions who are good risk patients for surgery and are likely to benefit from surgery due to long lesions or disease anatomy. In cases of TASC D lesions, endovascular surgery is done only in high-risk patients with multiple comorbidities such as CAD with low ejection fraction, COPD, HTN not fit for anesthesia.

Dosluoglu et al.[9] did a comparative study between stenting and open bypass surgery in TASC C and TASC D Lesion. Percutaneous transluminal angioplasty and stenting (PTA/S) for TASC-II C (PTA/S-C) or D (PTA/S-D) SFA lesions between June 2001 and April 2007 were retrospectively analyzed. In 127 patients, 139 limbs were treated (46 above-the-knee femoropopliteal, 49 PTA/S-C, and 44 PTA/S-D). The technical success rate was 84% and 100% in PTA/S-D and other groups, respectively. The mean follow-up was 26.4 months. The 12- and 24-month primary patency was 83% ± 6% and 80% ± 7% for PTA/S-C, 54% ± 8% and 28% ± 12% for PTA/S-D. In our study, overall primary patency at 1 year for stenting is 75% and primary patency rate for primary SFA DEB angioplasty of TASC D lesion is 94.4% which is similar to the study done by the Katsanos et al.[10] and Dosluoglu et al.[9]

Atherectomy provides an alternative to conventional angioplasty and stenting for the revascularization of patients with PAD by decreasing plaque burden. Biskup et al.[11] retrospectively reviewed 35 patients undergoing infrainguinal atherectomy in 38 limbs. Primary and secondary patency rates for femoropopliteal atherectomy were 68% and 73% at 1 year. In our study, the primary patency rate at 1 year for TASC D lesion where atherectomy was preferred was 70.3% which is similar to the study done by the Biskup et al. Role of atherectomy is not well defined and does not have very high patency rates.

In our study, limb salvage rate is 87.9% for open surgery, 92.6% for hybrid procedure, whereas 92% for the endovascular group, however, there is no statistical association between management versus amputation rate (P = 0.825). The limb salvage rate in open group is less probably due to the presence of poor distal runoff and nonhealing ulcers. ABI improvement is 0.60 ± 0.18 for the endovascular group, 0.70 ± 0.18 in the open surgery group and 0.75 ± 0.5 in the hybrid procedure. This shows that irrespective of TASC D lesions good limb salvage can be achieved.

The study had 13 patients (5.2% cases) of hematoma thigh postfemoropopliteal bypass since 2015, which is higher than the result of prevent III trial where they had a 0.4% incidence of hemorrhage. This complication may have occurred due to the use of generic heparin which gives variable activated partial thromboplastin time in different patients. Patients with thigh hematoma were managed with discontinuation of parenteral Heparin and compression, which halted the progression of the hematoma. Thirty-four patients required a blood transfusion in the postoperative period, the mean amount of blood transfused was 350 ml, which is due to the hematoma of thigh postfemoropopliteal bypass, one retroperitoneal bleed postiliac stenting and blood loss while doing trans femoral thrombectomy. Five patients (2.0%) had developed CFA pseudo aneurysm postangioplasty probably due to obesity which did not allow sufficient compression which is similar to the study done by Messina et al.[12] where they showed CFA pseudo aneurysm rate as 2% postinterventions. One patient (0.4%) with diabetes had iliac stenosis TASC C lesion with heavy dense calcification developed retroperitoneal hematoma postoperatively while doing Lt iliac stenting in the hybrid procedure. This complication occurred due to the rupture of calcified iliac artery postballoon angioplasty and stenting. This complication rate is similar to the study done by Tiroch et al.[13] where they showed the incidence of retroperitoneal hematoma during angioplasty as 0.49%.

Allaire et al.[14] showed in his study that failure to exercise basic safety principles and the presence of heavily calcified plaque are the major predictors of iliac artery rupture during balloon dilatation. In our study, we have found a similar problem in patients who have dense calcification. In such patients, endovascular approach may not be advisable as the wire traverses sub-intimally and during balloon angioplasty, the calcified media prevents expansion toward lumen and the radial force transmitted outwards can lead to rupture; hence, open surgery is recommended for heavily calcified vessels.

Fourteen patients (3.2%) developed early graft thrombosis who were managed with graft thrombectomy. This complication occurred probably due to hypotension or thrombus dislodging from the iliac artery, poor distal runoff, and prothrombotic state. An intraoperative fluoroscopic angiogram was done to rule out stenosis at the proximal and distal anastomosis site. Our graft thrombosis rate is lower than the study done by Campbell et al. who reported early femoropopliteal graft thrombosis rate is 10%. In our study, eight patients (3.2%) had graft infection which is similar to the study done by Campbell et al.[15] where he reported graft infection in 2.9% patients. Graft infection may be due to the hematoma, prolonged groin exposure, and extensive dissection.

In a study done by Dosluoglu et al.[4] MI rate was maximum in the hybrid group 5.6% as compared to 3.8 % in our study. Maximum MI cases in our study occurred in the endovascular group (5%) as compared to 1.2% in the study quoted. CVA occurred in 0.9% patients in the hybrid group, 0.2% in endovascular group, and 0.4% in open group in the study by Dosluoglu et al while in our study, 1.5% patients had CVA in open surgery and hybrid groups each exhibiting no significant difference in systemic complications between endovascular, open surgery, and hybrid procedure (P = 0.86).


  Conclusion Top


Peripheral arterial occlusive disease TASC D lesions in the fem-pop segment presenting with critical limb ischemia is a complex disease and is often associated with multiple comorbidities. Extensive lesions do not preclude successful endovascular treatment, especially in high-risk patients. Hybrid treatment is a suitable alternative for extensive TASC D femoropopliteal disease and can be accomplished in a less invasive manner, with most midterm outcomes comparable with open reconstruction. Because of findings of our study and similar results of several other studies, it is suggested that though open revascularization remains the treatment of choice for advanced Atherosclerotic diseases involving femoropopliteal segments (TASC D), hybrid procedures are not inferior to open procedures. This study also shows that primary patency and secondary patency in Indian patients is comparable with the Western statistics. DEB angioplasty after thrombectomy can be a primary modality option in patients having a long segment thrombus with a discrete femoropopliteal lesion. Hybrid procedures can be an alternative in patients with multiple co-morbidities with equal short term results and survival are nearly equivalent between endovascular surgery and open surgery group. Atherectomy as a primary treatment option has not stood the test of time.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al. ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): A Collaborative Report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA task force on practice guidelines (Writing committee to develop guidelines for the management of patients with peripheral arterial disease): Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; Transatlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation 2006;113:e463-654.  Back to cited text no. 1
    
2.
Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, et al. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA 2001;286:1317-24.  Back to cited text no. 2
    
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Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45 Suppl S: S5-67.  Back to cited text no. 3
    
4.
Dosluoglu HH, Lall P, Cherr GS, Harris LM, Dryjski ML. Role of simple and complex hybrid revascularization procedures for symptomatic lower extremity Occlusive Disease. J Vasc Surg 2010;51:1425-350.  Back to cited text no. 4
    
5.
Zhou M, Huang D, Liu C, Liu Z, Zhang M, Qiao T, et al. Comparison of hybrid procedure and open surgical revascularization for multilevel Infrainguinal Arterial Occlusive Disease. Clin Interv Aging 2014;9:1595-603.  Back to cited text no. 5
    
6.
Veith FJ, Gupta SK, Ascer E, White-Flores S, Samson RH, Scher LA, et al. Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstructions. J Vasc Surg 1986;3:104-14.  Back to cited text no. 6
    
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Klinkert P, Post PN, Breslau PJ, van Bockel JH. Saphenous vein versus PTFE for above-knee femoropopliteal bypass. A review of the literature. Eur J Vasc Endovasc Surg 2004;27:357-62.  Back to cited text no. 7
    
8.
AbuRahma AF, Robinson PA, Holt SM. Prospective controlled study of polytetrafluoroethylene versus saphenous vein in claudicant patients with bilateral above knee femoropopliteal bypasses. Surgery 1999;126:594-601.  Back to cited text no. 8
    
9.
Dosluoglu HH, Cherr GS, Lall P, Harris LM, Dryjski ML. Stenting vs. above knee polytetrafluoroethylene bypass for transatlantic Inter-Society consensus-II C and D superficial femoral artery disease. J Vasc Surg 2008;48:1166-74.  Back to cited text no. 9
    
10.
Katsanos K, Spiliopoulos S, Karunanithy N, Krokidis M, Sabharwal T, Taylor P, et al. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery. J Vasc Surg 2014;59:1123-33.  Back to cited text no. 10
    
11.
Biskup NI, Ihnat DM, Leon LR, Gruessner AC, Mills JL. Infrainguinal atherectomy: A retrospective review of a single-center experience. Ann Vasc Surg 2008;22:776-82.  Back to cited text no. 11
    
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Messina LM, Brothers TE, Wakefield TW, Zelenock GB, Lindenauer SM, Greenfield LJ, et al. Clinical characteristics and surgical management of vascular complications in patients undergoing cardiac catheterization: Interventional versus diagnostic procedures. J Vasc Surg 1991;13:593-600.  Back to cited text no. 12
    
13.
Tiroch KA, Arora N, Matheny ME, Liu C, Lee TC, Resnic FS, et al. Risk predictors of retroperitoneal hemorrhage following percutaneous coronary intervention. Am J Cardiol 2008;102:1473-6.  Back to cited text no. 13
    
14.
Allaire E, Melliere D, Poussier B, Kobeiter H, Desgranges P, Becquemin JP, et al. Iliac artery rupture during balloon dilatation: What treatment? Ann Vasc Surg 2003;17:306-14.  Back to cited text no. 14
    
15.
Campbell WB, Tambeur LJ, Geens VR. Local complications after arterial bypass grafting. Ann R Coll Surg Engl 1994;76:127-31.  Back to cited text no. 15
    


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