Simultaneous hybrid peripheral re-vascularization: early results

Introduction

Many studies conducted with non-invasive tests including large groups of patients indicated the prevalence of peripheral arterial disease as 1.4–1.9, 6.9 and 20%; within the age groups of 40–49, 50–59 and over 70, respectively.^1,2 Particularly in critical limb ischemia, five-year mortality rate is 46% and annual amputation rate is 27%. ³ Different strategies of re-vascularization are available in treatment of peripheral arterial disease that is very frequently seen and of poor clinical outcome if remaining unintervened. ¹ In addition to surgical methods, endoluminal interventions are being more commonly used in treatment of both aortoiliac and femoropopliteal occlusive arterial disorders. Hybrid procedures – combination of these surgical and endoluminal methods – gain popularity since mid-1990s.^4,5 Hybrid procedure becomes a good option of treatment when surgery is of less possibility due to co-morbidity and complex multilevel arterial disease. This procedure – although generally performed in separate sessions – may also be done simultaneously if an angiography device is available within the operating room. Beside its advantages regarding cost and duration, performing vascular surgical and endovascular interventions simultaneously in the same operating room provides angiographic control of the surgical intervention. ¹ In this study, our patients undergoing simultaneous hybrid peripheral interventions were investigated.

Methods

This study was conducted retrospectively. The Ethics Committee (institutional review board) of our university does not require official approval for retrospective studies. Therefore, this approval was not obtained. Eleven patients that underwent simultaneous peripheral hybrid re-vascularization for occlusive peripheral arterial disease without aneurysms between June 2008 and November 2010 were evaluated. Hospital records were examined in order to follow-up postoperative clinical parameters of the patients. All of these patients were men with an average age of 65.7 ± 8.8 years (50–79). All of them were smokers. In addition, as risk and co-morbid factors; eight patients were hypertensive (≥140/90 mmHg), six patients were hyperlipidemic (LDL≥100 mg/dL), four patients were diabetic (DM), two patients experienced cerebrovascular occlusion and three patients underwent coronary bypass surgery priorly. Demographic data and clinical characteristics of the patients are shown in Table 1.

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Table 1

Demographic data of patients

	n:11
Age	65.7 ± 8.8 (50–79)
Male gender	11 (100%)
Smoking	11 (100%)
HTN	8 (73%)
HPL	6 (55%)
DM	4 (36%)
COPD	5 (45%)
CVO	2 (18%)
CABG	3 (27%)

Clinical conditions of the patients concerning peripheral arterial disease were between Fontaine Class II and IV. Two patients were suffering from intermittent claudication but they did not have ischemic ulcer or resting pain. Four patients had resting pain with no ischemic ulcer. The remaining five patients were presented with resting pain and ischemic ulcers. As preoperative investigations, all the patients underwent arterial Doppler ultrasound, arteriography and ankle-brachial index (ABI) measurements that were then recorded. Coronary angiography was obtained from patients with high risk for coronary artery disease; but, none of them required coronary bypass surgery. Peripheral arterial lesions of the patients are summarized in Table 2.

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Table 2

Peripheral arterial lesions of the patients and associated vascular interventions

Patient no.	Lesion	Percutaneous intervention	Surgical intervention
1	(R) EIA TASC A	(R) EIA − PTA	(R) CFA, DFA and SFA − TEA + patch plasty with Dacron® graft
	(R) CFA TASC B
2	(R) EIA TASC A	(R) EIA − PTA + 9 × 40 mm Stenting	(R) CFA, DFA ve SFA − TEA + patch plasty with Dacron® graft
	(R) CFA TASC B
3	(L) CIA TASC A	(L) CIA − PTA + 9 × 50 mm Kissing Stenting	(L) Supragenual FPB with saphenous vein graft
	(L) SFA TASC C
4	(L) EIA TASC D	(L) SFA − PTA + 6 × 50 mm Stenting	R-to-L FFB
	(L) SFA TASC A
5	(L) CIA TASC D	(R) SFA − PTA + 6 × 50 mm Stenting	R-to-L FFB
	(R) SFA TASC A
6	(R) EIA TASC A	(R) EIA − PTA	(R) infragenual FPB with saphenous vein graft
	(R) SFA TASC D
7	(R) EIA TASC D	(R) SFA − PTA + 6 × 50 mm Stenting	L-to-R FFB
	(R) SFA TASC A
8	(L) EIA TASC A	(L) EIA − PTA	(L) Supragenual FPB with saphenous vein graft
	(L) SFA TASC D
9	(L) EIA TASC D	(L) SFA − PTA + 6 × 50 mm Stenting	R-to-L FFB
	(L) SFA TASC A
10	CIA TASC B	(R) CIA − PTA + 9 × 40 mm Stenting	R-to-L FFB
11	CIA TASC B	(L) CIA − PTA + 8 × 40 mm Stenting	L-to-R FFB

As indicated in Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II), surgical procedures were performed in order to relieve ischemic pain, heal ischemic ulcer, prevent extremity loss and improve quality of life or survival. ⁶

Hybrid procedure

 Before the intervention, all the patients received daily doses of 300 mg aspirin and 75 mg clopidogrel for three days. Intraoperatively, a standard dose of 5000 IU heparin was administered intravenously. Two patients undergoing profundoplasty and femoral endarterectomy were operated on under local anesthesia; whereas six patients were operated on under regional anesthesia in order to avoid general anesthesia due to co-morbid factors, and remaining three patients were operated on under general anesthesia. The literature data concerning hybrid procedures showed that surgical procedure was performed initially followed by endovascular procedure, since these interventions were done at different rooms and sessions. ¹ But, in our approach, since endovascular interventions were required for inflow arteries we performed endovascular procedures first. But, for two patients requiring endovascular intervention to superficial femoral artery (SFA), since there were additional ipsilateral iliac artery lesions, contralateral common femoral artery (CFA) was selected for inflow artery. Therefore, femorofemoral bypass (FFB) surgery was performed on these patients. Nevertheless, control angiograms were held for all of the patients intraoperatively. Endovascular intervention was performed via inserting a 5 Fr or 7 Fr introducer sheath into CFA ipsilateral to the lesion to be intervened with percutaneous transluminal angioplasty (PTA) and/or stenting. Since kissing balloon angioplasty was performed on one patient, his contralateral CFA was also catheterized. Endovascular approach was performed on patients with TASC A and TASC B lesions, whereas surgical approach was preserved for TASC D lesions (hybrid procedure was performed on one patient with TASC C lesion only). All the cases underwent PTA primarily; then, if necessary, stenting was also performed. Three patients underwent only PTA, whereas eight patients underwent both PTA and stenting (Table 2). Patients with unsuccessful endovascular approach were subjected to open surgery and they were excluded from the study. In addition, patients with impaired renal function (serum creatinine concentration >2.0 mg/dL) and a previous history of contrast allergy were excluded. After the endovascular intervention, if the insertion site of the introducer sheath was subjected to surgical procedure it was removed. Otherwise it was kept in its place for control angiography until the end of the operation. As surgical procedure, two patients underwent thromboendarterectomy including deep femoral artery and Dacron patch plasty after endovascular procedure. Six patients underwent FFB with an 8 mm expanded polytetrafluoroethylene (ePTFE) graft and remaining three patients underwent femoropopliteal bypass (FPB) with reversed saphenous vein graft (Table 2). If previously inserted introducer sheath was removed, it was re-inserted into a suitable arterial site and control angiogram was held after the surgical procedure (Figures 1–3). OPEN IN VIEWER

Figure 1

Preoperative angiography showing occlusion of the left common iliac artery and stenosis of the right common iliac artery. A 61-year-old male patient with complaints of Fontaine Class II in left lower limb. He had a past medical history significant for laparotomy and chronic obstructive pulmonary disease

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Figure 2

Percutaneous transluminal angioplasty and stent implantation to the right common iliac artery. A 61-year-old male patient with complaints of Fontaine Class II in left lower limb. He had a past medical history significant for laparotomy and chronic obstructive pulmonary disease

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Figure 3

Control angiography after femorofemoral bypass (R to L) using 8 mm ringed polytetrafluoroethylene graft. A 61-year-old male patient with complaints of Fontaine Class II in left lower limb. He had a past medical history significant for laparotomy and chronic obstructive pulmonary disease

All the patients received heparin infusion during early period after hybrid procedure. In addition, 75 mg of clopidogrel every day was given for one year. Twenty milligram of rosuvastatin every day was given lifelong with the control of serum biochemical parameters. These patients were also referred for supervised physical therapy again for one year.

During follow-up period, clinical status of a patient was evaluated with ABI measurement and color Doppler ultrasound. Mean follow-up period was 20.8 ± 9.9 (6–34) months.

Hybrid operating room

Our hybrid operating room contains a mobile C-arm with image intensifier (BV Endura, Philips Medical Systems, 2007, PC Best, Netherlands), carbon fiber imaging table, two imaging monitors, contrast injector, operating room lighting system, anesthesia device and related monitors, heart-lung machine, heat exchanger, cautery, aspirator, scrub nurse table, transesophageal echocardiography device and a vascular Doppler ultrasound device (Figures 4 and 5). OPEN IN VIEWER

Figure 4

Our hybrid operating room

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Figure 5

Another view of our hybrid operating room

Results

Discussion

The issue about ‘what is the best treatment modality in complicated iliofemoral occlusive disease’ is controversial. Both open surgery and endovascular methods have advantages and disadvantages.^7,8 For this reason, preoperative findings of the patients should be carefully evaluated. The optimal therapy is generally individualized since each patient is evaluated with his/her own radiological and clinical findings. Either one of these two methods may be chosen or they both may be combined.^9–11 Since endovascular procedures usually are performed by interventional radiologists in angiography suites, hybrid procedures are carried out by stages. Nevertheless, as in our study, these procedures could be done in hybrid operating rooms where angiography devices are available.^12–16

Hybrid procedures – when they were first introduced in 1970s – only contained angioplasty to external iliac artery that was going to be used for inflow artery in high-risk patients undergoing FFB.^17,18 But, advances in technology and increasing procedural experience of practitioners enabled us to perform angioplasty not only to iliac artery, but also to femoral artery.^1,15,16 In our study, we performed PTA and/or stenting to external iliac artery (EIA) and/or SFA. Site for endovascular interventions show variations in hybrid procedures as diversity of surgical procedures. Investigating the literature data shows that the most common surgical interventions for hybrid procedure are FFB, femoral endarterectomy and supra- and infragenual FPB.^10–14 Nevertheless, some femorodistal bypass procedures are available in some recent studies.^15,16 In our study, we performed femoral endarterectomy, FFB and FPB surgeries from above-mentioned procedures. But, femorodistal bypass procedures were not carried out.

In a study by Hamilton et al., 13 patients undergoing open surgery for peripheral arterial disease were investigated with intraoperative angiography. Twenty-six arterial lesions were detected and intervened by endovascular methods. One patient was lost perioperatively due to myocardial infarction. ABIs increased from 0.41 up to 0.74 at the end of 30th postoperative day. ¹² In another study, 10 patients undergoing intraoperative PTA or stenting to iliac artery followed by FPB were investigated. Mean follow-up period was five months and primary patency rates were 100, 100 and 90% for iliac stenting, FFB and FPB, respectively. In the same study, amputation ratio was 8.3%. ¹³ Lau et al. ¹⁴ reported that postoperative ABIs improved significantly and one-year patency rates were 100% in iliac stents and 85% in infrainguinal FPBs in a study including 13 patients undergoing simultaneous iliac artery PTA or stenting and infrainguinal FPB operation. In another study conducted by Nelson et al., 34 patients were evaluated undergoing simultaneous external iliac arterial stenting and endarterectomy to CFA. As a result, they reported that ABIs improved significantly during postoperative period and one-year primary and secondary patency rates were reported as 84 and 97%, respectively. Overall complication rate was identified as 15%. ⁸ One-year patency rate was reported as 68% in a study conducted among 22 patients undergoing concomitant PTA or PTA + stenting to SFA followed by popliteodistal bypass. ¹⁵ In one of the recent studies evaluating the results of the hybrid procedures, Dosluoglu et al. ¹⁶ compared the results of open surgery, endovascular procedure and hybrid approach in a group of 654 patients. According to the results of this study, there was not any significant difference detected among open surgery, endovascular procedure and hybrid approach in terms of 1-, 2- and 3-year primary patency rates. Nevertheless, such complications as graft occlusion, major amputation and bleeding were less commonly observed at the end of postoperative first month in hybrid procedure when compared with those of open surgery. But, incidence of non-fatal myocardial infarction and mortality rate were higher in hybrid group comparing to the remaining two groups.

While evaluating the results of the hybrid procedures; co-morbid factors, clinical stage of the peripheral arterial disease and particularly the localization of the performed surgical procedure should be taken into account. For example, in hybrid procedures, surgical interventions performed on the distal vessels of the lower extremities particularly have lower patency rates than those of other localizations. ¹⁵ In our study, although surgical interventions of hybrid procedures were performed at different localizations, improvement in ABI and primary patency rates were consistent with the literature data.

Limitations for this study are small number of patients, retrospective conduction of the study, lack of a control group and diversity of the surgical and endovascular interventions due to different localizations of the lesions. Thus, drawing a significant conclusion from this study may not be possible. In fact, this work is mainly a feasibility study.

Consequently, hybrid procedures could be carried out by experienced surgical teams in suitable operating rooms in complex cases, particularly due to some advantages as shorter duration of operation, lower frequency of such complications as bleeding and wound infections and – most importantly – ability to check the results of the surgical intervention intraoperatively by control angiography. Although the early-term results of these procedures are promising, further investigations including larger patient groups and longer follow-up periods are needed.