Management of critical situations during percutaneous transluminal angioplasty of lower limb ischemia

Introduction

 The treatment of  lower  limb ischemia has changed dramatically because of the explosion of catheter-based interventions. In recent years, percutaneous transluminal angioplasty (PTA) has become the first-line option in the treatment of lower  limb ischemia as it allows the healing of ulcers, diminution of rest pain and improvement of claudication distance with low complications.^1,2

As in every therapeutic procedure, endovascular procedures such as angioplasty and stenting carry an inherent risk of complication to the patient. Though with the proper training these complications can usually be successfully managed endovascularly, improper management may lead to emergency surgery, limb loss, functional disability, and death. It is paramount that physician operators have the proper training and ability to anticipate and recognize complications as they arise during endovascular procedures.³

Acute vascular complications at the endovascular procedure site include arterial perforation, dissection, arteriovenous fistulas, thrombosis, spasm, side branch occlusion, and equipment failure.⁴

Patient and Methods

Sixty five patients with manifestations of lower limb ischemia, underwent for percutaneous transluminal angioplasty and had developed critical situations during the procedure. All primary procedures were done under local anesthesia in the angio suit at the vascular surgery department in AL-Hussein university hospital and Agouza police hospital from march 2018 to march 2020.

All were studied for immediate complications that occur during the percutaneous transluminal angioplasty of lower limb arteries and need bailout procedures to save the limb or the patient; this complications included puncture site complications, Residual stenosis ≥30%, Flow-limiting Dissection, Perforation or Rupture, Thrombosis, stent

deployment complications, Arterial spasm or wire embolization.

The main objective of this study is to evaluate the results of management procedures for critical situations that happened during percutaneous transluminal angioplasty of lower limb ischemia.

Patients included in this study were suffering from lower limb ischemia with Rutherford class 3 to 6 clinically, with any morphological lesion according to TASC II classification and underwent complications during PTA.

But patients excluded from this study who were unsuitable for angioplasty as Renal insufficiency, Contrast allergy. PTA procedures without complications and procedures with late complications.

All patients underwent evaluation by complete history taking about personal data, Risk factors (smoking, DM, hypertension, hyperlipidemia), Co-morbidities (previous stroke, angina, MI and CKD), previous PAD interventions to one or both legs, previous amputation, history of presenting symptom (rest pain or tissue loss) and previous coronary intervention (CABG, PCI).Rutherford class 3 to 6 clinically.

All patients presented subjected to detailed clinical evaluation for avoidance of contrast allergy, complete laboratory assessment for avoidance of renal insufficiency, complete cardiac assessment by Echo Doppler for avoidance of heart failure, and arterial duplex ultrasound imaging study and CT angiography of both lower limbs for diagnosis and assuring the preparation.

Management procedures:

All interventions were done in angio suite under local anesthesia. The management of complications were depended on the disease location and the type of complications.

For Residual stenosis ≥30% balloon dilatation by lager diameter balloon was done and stenting was done in cases of failed angioplasty.

For dissections balloon dilatation by lager diameter balloon was done for long time 3 mins then completion angiography was done and stenting was done in cases of failed angioplasty (residual flow limiting dissection).

But for perforations large compliant balloon was inflated for 3 to 5 mins for cases with ruptured vessels; covered stent, surgical bypass and life saving ligation of the artery in case of failed control.

For thrombosis; thrombectomy was done during the angioplasty by fogarthy over the wire or suction of the fresh thrombus by bern catheter,some cases were managed by angioplasty and open surgical thrombectomy was done in 2 cases.

In cases with developed AVF prolonged balloon inflation at the site of AVF for 3:5 mins, then angiography was done to confirm closure of the fistulae.

 In arterial spasm vasodilator agent (nitroglycerine, papaverine, and verapamil) were administered and the guide wire have to be removed to distinguish refractory spasm from dissection.

The endpoint of the procedure was unrestricted forward flow of contrast with no evidence of significant (>30%) residual stenosis. The run-off was assessed at the end of the procedure for the occurrence of distal embolization caused by the PTA or stent insertion.

Primary outcomes: Technical success: Arterial patency to the lower limb known by presence of antegrade blood flow through the lesion at the end of the  procedure.

Secondary outcome parameters:

1-Clinical response that can be known from improvement of symptoms.

2-Hemodynamic success is defined as an increase in ankle brachial index of 0.10 to 0.15 or greater.

Results

The current study was a prospective randomized controlled study that conducted on 65 patients complaining lower limb ischemia; 39 (60%) males and 26 (40%) females. Patients with age less than 50 years old was 6 (9.2%), from 50 to 60 years old were 20 (30.8%) but patients older than 60 were 39 (60%) of all patients in the study who were collected from vascular surgery department in AL-Hussein university hospital and Agouza police hospital.

According to the risk factors and co-morbidities of the patients in the study; 49 (75.4%) were diabetic, 35 (53.8%) were smokers,47 (72.3%) were hypertensive, 25 (38.5%) with ischemic heart disease, 7 (10.8%) had a previous stroke and 30 patients (44.8%) had more than 2 risk factors and co-morbidities.

As regard symptoms presented by the patients in the study; 3 patients were complaining sever claudication (disabling claudications) that harm their life style (Rutherford category 3), 12 (18.5%) presented with ischemic rest pain (Rutherford category 4), 31 (47.7%) presented with minor tissue loss (Rutherford category 5), 19 29.2%) presented with major tissue loss (Rutherford category 6)

According to primary lesion morphology in this study; Iliac lesions TASC A no cases, TASC B  one case 20%, TASC C 3 (60%), TASC D single case (20%). Femoral lesions no cases of TASC A, 6 (21.5%)cases with TASC B lesion, TASC C 13 (46.5%) and TASC D  9 (32%). Popliteal artery lesions were: no cases with TASC A and C, TASC B 4(25%)and TASC D 12(75%). Tibial lesions were : TASC A 1(6.25 %) , TASC B 2(12.5 %) ,TASC C 6(37.5%)  and TASC D 7(43.75%). Over all 1.5% of TASC A , 20% of cases had TASC B lesions, 33.8% of patients had TASC C lesions , 44.6% of patients had TASC D- as in table  (2)

Complications that happened during endovascular intervention classified according to site of complication into; Iliac 5 (7.7%), SFA complications ware 28 (43.1%), popliteal artery complications 16 (24.6%) and complications that happened in tibials were 16 (24.6%).

 The critical situations that happened during endovascular intervention were classified according to type into; Dissection 35 (53.8%), Perforation 20 (30.8%), Thrombosis 6 (9.2%), 4 (6.2%) cases with  early Arteriovenous fistula and 2 (3.1) cases of residual stenosis. Two cases developed more than one type of complications during intervention )Dissection and perforation). Most of cases were managed endovascular 61 (93.8%) but 4(6.2%) cases managed by surgical methods.

In 65 cases developed critical complications; 63 (96.6%) cases had saved their limbs and avoided major amputations and two cases were gone for major amputations. In this study there was no immediate mortality.

In this study there were 35 cases of dissection distributed according to site; Iliac 3(8.5%), SFA 21 (60%), POP 10 (28.5%) and tibials one case (2.9%). 20 cases of perforation 13 of them (65%) in tibial arteries and 7 (35%) in tibial arteries. 6 cases of thrombosis; 2 of them (33.3%) in pop artery and 4 cases (66.6%) were in SFA. 4 cases developed AVF; 2 (50%) were in pop artery and 2 (50%) in tibial arteries. 2 cases of residual stenosis were in iliac arteries.

Two cases were gone for above knee amputation; one case of SFA perforation that failed to be managed by endovascular tools and managed by ligation of the femoral artery as a life saving procedure. The other case was case of SFA thrombosis and the open thrombectomy was failed and the patient had bad general conditions (EF 30%) with diseased out flow vessels.

Dissection was the most common type of complication in this study 35 cases 3 of them (8.5%) were in iliac arteries; 2 cases (66.7%) were managed by stenting and one case (33.3%) was managed by balloon. In SFA 21(60%); 18 (82.7%) of SFA dissections were managed by stenting  and 3(14.3%) were managed by balloon inflation. Pop dissections were 10 (28.5%) cases; 8 (80%) were managed by balloon inflation and 2 cases (20%) were managed by stenting with bare metal stent (supera stents weren’t available). Only one case developed critical flow limiting dissection in tibial arteries and managed by long standing inflation balloon 3-5 mins

As regard perforation; 10 cases of perforation 3 of them were in tibials and 7 cases were in SFA.

In SFA cases; 4 (57.1%) managed by balloon inflation, one case (14.1%) was managed by covered stent, one case (14.1%) was managed by surgical bypass after failure of endovascular management and one case (14.1%) failed to be managed by endovascular tools and managed by ligation of the artery for life saving. In tibials all cases (100%) of perforation were successfully managed by long inflation balloon.

In this study 6 cases of critical thrombosis 4 of them were in pop artery and 2 cases were in SFA. Cases of SFA thrombosis; one case was managed by thrombolytic therapy and one case was managed by surgical thrombectomy 50% for each method. Cases of pop thrombosis were managed by; surgical thrombectomy one case 25%, angioplasty one case 25% and 2 cases were managed by suction catheter.

As regard AVF that occurred during interventions; 2 cases were developed between pop artery and vein and 2 cases in tibials all cases successfully managed by long inflation balloon and the fistulae were closed.

In this study there were two cases of critical residual stenosis. The 2 cases were in iliac arteries and successfully managed by stenting with limb salvage 100%.

Upon review of the management procedure there were primary outcome parameters; technical success was reported in 63 (96.9%) of cases. Clinical response in 60 (92.3%) and haemodynamic success in 61 cases (93.8%). And 4 (6.1%) managed surgical.

Figure (1) femoral axis                                                                 Figure (2) Sheath 6F

Figure (3) Case of SFA dissection and perforation perforation managed by balloon that couldn’t manage the large dissection.

Figure (4) case of popliteal fistula managed by balloon inflation.

Figure (5) Case 3 of iliac dissection managed by iliac stent.

Figure (6) case of long spiral SFA Dissection managed by stent.

Table (1) Distribution of the studied cases according to risk factors (n = 65)

Figure (7) Distribution of the studied cases according to rutherford category (n = 65)

Table (2) patients with TASC

Figure (8) Distribution of the studied cases according to site of complication (n = 65)

Figure (9) Distribution of the studied cases according to type of complication and management.

Table (3) Distribution of the studied cases according to limb salvage and mortality (n = 65)

Figure (10) Relation between type complications and site complication.

Table (4) relation between limb salvage and type of complication (% from raw)

Figure (11) Relation between Site complication and procedure in dissection type (n= 35)

Figure (12) Relation between Site complication and procedure in perforation type (n= 20)

Table (4) Relation between Site complication and procedure in thrombosis type (n= 6)

Table (5) management of AVFs.

Table (6) relation between Site complication and procedure in Residual stenosis type (n= 2)

Table (7) study outcome