Complications following peripheral angioplasty.

The Royal

Ann R Coll

College of Surgeons of England

Surg Engl 2002; 84: 39-42

Original article

Complications following peripheral angioplasty B Axisal, G Fishwick2, A Bolia2, MM Thompson', NJM London', PRF Bell', AR Naylor' Departments of 'Vascular Surgery and 2Radiology, Leicester Royal Infirmary, Leicester, UK Background: Peripheral angioplasty is increasingly the first choice intervention in patients with peripheral vascular disease. The aim of the current study was to audit prospectively all major complications, especially the requirement for emergency surgical intervention. Patients and Methods: A prospective audit of outcome after peripheral angioplasty in 988 patients undergoing 1377 interventional procedures between 1 October 1995 and 30 September 1998 at which 1619 vessel segments were angioplastied. Results: Major medical morbidity (bronchopneumonia, stroke, renal failure, myocardial infarction) complicated 33/1377 procedures (2.4%). Emergency surgical intervention was required after 31/1377 procedures (2.3%) with the commonest aetiologies being acute limb ischaemia and haemorrhagic complications. The amputation rate following angioplasty was 0.6% and no patient presenting with claudication or graft complications underwent amputation. The amputation rate following angioplasty for critical limb ischaemia was 2.2%. Overall, the risk of death and/or major medical complication and/or requiring emergency surgical intervention was 3.5%. The rate of complications was no different for subintimal as opposed to transluminal angioplasties. Conclusions: Peripheral angioplasty is associated with a low risk of major medical and surgical complications. Key words: Complications

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Peripheral angioplasty Prospective audit

Following the introduction of peripheral angioplasty in the 1970s, surgeons expressed concem that there would be an unacceptable increase in the incidence of complications. However, this has not generally proved to be the case and the number of angioplasties has increased annually in most vascular units. For some, angioplasty is the first line treatment in up to 60% of cases of critical ischaemia.' There is, however, relatively little information from large scale studies on whether the complication rate has altered with the change in referral practice. At the Leicester Royal Infirmary, the annual number of peripheral angioplasties has increased from 300 in 1989 to >600 in 1998. This increase was partly due to an expanding

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referral practice, but was also due to the introduction of subintimal angioplasty which enabled longer occluded segments of disease in high risk patients to be treated.23 The aims of the current study were to audit prospectively the incidence of major medical complications and those complications requiring emergency surgical intervention. Patients and Methods A prospective audit was maintained of all major complications following peripheral angioplasty in 988 consecutive patients (551 males, 437 females, mean age 62.5 years) between 1 October 1995 and 30 September 1998 in

Correspondence to: Mr AR Naylor, Department of Surgery, Clinical Sciences Building, Leicester Royal Infirmary, Leicester LE1 5WW, UK. Tel: +44 116 2523252; Fax: +44 116 2523179; E-mail: [email protected] Ann R Coll Surg Engl 2002; 84

39

AXISA

COMPLICATIONS FOLLOWING PERIPHERAL ANGIOPLASTY

Table I Major medical morbidity after angioplasty

Stroke/TIA Renal failure Myocardial infarction Pulmonary embolus

Bronchopneumonia Total

Total (n = 1377)

Subintimal (n = 660)

Transluminal (n = 717)

6 6 6 14

5 1 1 1 8

1 5 5 0 6

33 (2.4%)

16 (2.4%)

17 (2.4%)

1

were not included in the audit. Any death occurring within 30 days was also classified as a procedural complication. For the purposes of analysis, the denominator for the calculation of complications was 1377 (i.e. the number of interventional procedures) rather than the number of segments angioplastied. Results Medical complications

the vascular unit at Leicester Royal Infirmary. The principal aim was to identify the incidence of complications requiring emergency surgical intervention following a total of 1377 procedures at which 1619 arterial segments were angioplastied. Of the 1377 interventions, 841 (61%) were for the relief of disabling claudication, 366 were for critical limb ischaemia (26.6%), while 170 angioplasties (12.4%) were for the maintenance of infra-inguinal graft patency with abnormalities of the graft body or inflow/run-off vessels being detected on Duplex surveillance. Method of angioplasty

The methods for performing transluminal and subintimal angioplasty have been detailed elsewhere.2'3 All procedures were performed by a consultant radiologist (AB, GF) or by a trainee under supervision. A single vessel was angioplastied in 612/1377 procedures (44.4%), while >1 arteries were angioplastied at one interventional session in 765 (45.6%). Overall, 660 interventions (48%) were by the subintimal technique alone while 717 (52%) were either completely transluminal or in combination with a partial subintimal approach. Of the 1619 arterial segments dilated during this audit, 349 (21%) involved aorto-iliac vessels (aorta, common and external iliac arteries), 1032 (64%) were suprageniculate (common femoral, profunda femoris, superficial femoral, above knee popliteal arteries), 161 (10%) were infrageniculate (below knee popliteal, tibial, pedal arteries), while 77 (5) involved the body of an infrainguinal vein bypass graft. Audit of complications All major medical complications were prospectively audited but were based on a clinical diagnosis rather than specific diagnostic testing (e.g. cardiac enzymes were not tested). Contrast reactions were only included if they caused anaphylaxis. Any angioplasty complication requiring emergency surgical intervention was specifically audited together with the underlying reason. However, elective secondary surgical intervention (e.g. following unsuccessful angioplasty with no associated clinical deterioration) 40

Thirty-three procedures (2.4%) were complicated by major medical morbidity (Table 1), with the commonest being bronchopneumonia followed by stroke/TIA, renal failure requiring dialysis (five had pre-existing renal impairment) and myocardial infarction. Medical morbidity was unrelated to the technique of angioplasty. No patient developed acute anaphylaxis after angioplasty. Emergency surgical intervention

Thirty-one interventions (2.3%) underwent emergency surgery after angioplasty (Table 2). The commonest reasons were acute limb ischaemia following 21 procedures (1.5%) and haemorrhagic complications) in eight (0.6%) - retroperitoneal haematoma (n = 3), groin false aneurysms (n = 2) and groin haemorrhage (n = 3). Four patients with claudication developed acute limb ischaemia after angioplasty (0.5%) as compared to 15 with critical ischaemia (4%) and two requiring angioplasty for graft complications (1.2%). Subintimal angioplasty was associated with acute ischaemia following eight procedures (1.2%) as compared to 13 undergoing transluminal angioplasty (1.8%). There was no difference in the incidence of acute ischaemia in patients with single or multiple vessel angioplasties. However, for those undergoing isolated segment interventions the incidence increased as the procedure became more distal. Patients undergoing isolated angioplasty of the aorto-iliac segment disease had the lowest incidence of acute ischaemia - 2/134 (1.5%) as compared with 8/375 (2.1% ) in patients undergoing isolated suprageniculate angioplasty and 3/54 (5.5%) of patients undergoing an isolated infrageniculate angioplasty. The Table 2 Emergency surgical intervention after angioplasty

Total (n = 1377)

Subintimal (n = 660)

Transluminal (n = 717)

21 8 1 1

11 4 1 1

10

31 (2.3%)

17 (2.6%)

14 (2.0%)

Acute limb ischaemia

Haemorrhagic problems Wound abscess GI perforation Total

4 0

0

Ann R Coll Surg Engl 2002; 84


Table 3 Surgical management of patients with acute limb ischaemia after angioplasty

Successful bypass Embolectomy alone Failed bypass + amputation* Embolectomy + bypass + amputation* On-table lysis + amputation* Primary amputation

7 6 4

3 1 3

4 5 1

1 1 2

0 0 1

1 1 1

Total

21

8

13

*Refers to above or below knee amputation. Table 4 Causes of death after angioplasty

Bronchopneumonia

Subintimal Transluminal

Myocardial infarction Renal failure GI perforation Septicaemia

10 5 1 1 1

4 1 0 1 1

6 4 1 0 0

Total

18

7

11

surgical management of patients with acute limb ischaemia following angioplasty is summarised in Table 3. Thirteen patients (62%) achieved limb salvage by either simple embolectomy (n = 6) or bypass (n = 7). The remaining eight patients required a major amputation although six had undergone attempts to salvage the limb. Three patients undergoing surgery for acute limb ischaemia (14%) died within 30 days. Overall, subintimal angioplasty was associated with an amputation rate of 0.6% as compared with 0.5% for transluminal angioplasty. None of the patients undergoing angioplasty for claudication or graft complications lost a limb. However, eight procedures for critical ischaemia (2.2%) were complicated by amputation. Procedural mortality

Eighteen patients (1.3%) died within 30 days of angioplasty (Table 4). The principal cause of death was bronchopneumonia, usually in very elderly, infirm patients undergoing an unsuccessful angioplasty for critical ischaemia in whom a decision had been taken not to undertake any further intervention. No patient undergoing angioplasty for claudication or graft related problems died following angioplasty. However, 18 patients undergoing angioplasty for critical ischaemia (4.9%) died within 30 days. Overall, the rate of death and/or major medical complication and/or requiring emergency surgical intervention was Ann R Coll Surg Engl 2002; 84

3.5% overall (48/1377), 3.9% for subintimal procedures (26/660) and 3.1% for transluminal angioplasties (22/717).

Subintimal Transluminal

Total

Total

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Discussion A number of centres around the world have documented a significant increase in the annual number of angioplasties being performed4 and the reasons for this are multifactorial. In Leicester, the change in practice has evolved because of: (i) increased access to the angioplasty suite following abolition of routine diagnostic angiography and increased reliance on Duplex imaging5 (ii) the emergence of a secondary/tertiary vascular referral practice; (iii) the emergence of subintimal angioplasty which enables more complex and distal endovascular interventions to be performed;1-3 (iv) a greater desire to achieve limb salvage in diabetic and increasingly elderly patients using minimally invasive techniques;' and (v) a general liberalisation of indications for angioplasty in patients with claudication. However, there are virtually no data indicating whether the increase in the number of angioplasties has been associated with a parallel increase in the number of medical and surgical complications. A review of the literature suggests that 4-18% of patients will suffer some complication following angioplasty," although this figure will inevitably vary according to casemix. In the current series, the risk of suffering a major medical complication was 2.4%, with the commonest single problem being bronchopneumonia. The latter, however, most commonly arose in elderly, infirm patients with advanced critical ischaemia in whom a decision had been made not to intervene further should angioplasty be unsuccessful. Accordingly, bronchopneumonia accounted for 56% of all deaths in this series. The incidence of complications requiring emergency surgical intervention was small (2.3%) and in accordance with the 1.6-3.6% experience reported in smaller series elsewhere.*8 The commonest single reason for emergency surgical intervention following angioplasty was acute limb ischaemia (1.5% incidence overall). However, despite being relatively rare, acute ischaemia following angioplasty carried a 38% risk of major limb amputation and a 14% risk of death. We found no evidence that the risks were increased in patients undergoing more extensive angioplasties as opposed to single segment procedures, although others have observed that longer segment angioplasties were associated with greater risk.9 There was also no difference between subintimal and transluminal procedures. The study was not specifically designed to evaluate factors such as stenosis or occlusion length, but our experience suggests that gross calcification, a prolonged procedure and recent thrombus were associated with an adverse risk of acute ischaemia. As expected, the risks of acute ischaemia, amputation and 41

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death in this and other series were lowest in patients presenting with claudication and highest in patients with critical limb ischaemia.8'9 Conclusions In summary, the annual number of angioplasty procedures has increased dramatically throughout the world over the last 10 years. Although there remains considerable debate as to whether patients should be offered angioplasty or surgical reconstruction, evidence suggests that the increase in the angioplasty workload has not precipitated a parallel increase in either morbidity/mortality or the requirement for emergency surgical intervention. In particular, the anticipated increase in procedural risk in patients with critical ischaemia has not been observed. In common with other units,'0"'1 angioplasty is now the first line treatment in up to 60% of patients with critical ischaemia who can expect a low procedural risk and equivalent outcomes to surgery at 12 months.'

References 1. Varty K, Nydahl S, Nasim A, Bolia A, Bell PRF, London NJM. Results of surgery and angioplasty for the treatment of chronic severe lower limb ischaemia. Eur J Vasc Endovasc Surg 1998; 16: 159-63.

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2. London NJM, Naylor AR, Srinivasan R, Ratliff DA, Bell PRF, Bolia A. Subintimal angioplasty of femoro-popliteal artery occlusions: The long-term results. Eur I Vasc Surg 1994; 8: 148-55. 3. Varty K, Bolia A, Naylor AR, Bell PRF, London NJM. Infra-popliteal percutaneous transluminal angioplasty: a safe and successful procedure. Eur I Vasc Endovasc Surg 1995; 9: 341-5. 4. Pell JP, Whyman MR, Fowkes FG, Gillespie I, Ruckley CV. Trends in vascular surgery since the introduction of percutaneous transluminal angioplasty. Br J Surg 1994; 81: 832-5. 5. London NJM, Sensier Y, Hartshome T. Can lower limb ultrasonography replace angiography? Vasc Med 1996; 1: 115-9. 6. Spence LD, Hartnell GG, Reinking G, Gibbons G, Pomposelli F, Clouse ME. Diabetic versus non-diabetic limb-threatening ischaemia: Outcome of percutaneous iliac intervention. Am I Roentgenol 1999; 172: 1335-41. 7. Nawaz S, Cleveland T, Gaines P, Beard J, Chan P. Aorto-iliac stenting: determinants of outcome. Eur J Vasc Endovasc Surg 1999; 17: 351-9. 8. Matsi PJ, Manninen HI. Complications of lower limb percutaneous transluminal angioplasty: a prospective analysis of 410 procedures on 295 consecutive patients. Cardiovasc Intervent Radiol 1998; 21: 361-6. 9. Currie IC, Wakeley CJ, Cole SE, Wyatt MG, Scott DJ, Baird RN et al. Femoro-popliteal angioplasty for severe limb ischaemia. Br J Surg 1994; 81: 191-3. 10. Lofberg AM, Lorelius LE, Karacagil S, Westman B, Almgren B, Berqqvist D. The use of below knee percutaneous transluminal angioplasty in arterial occlusive disease causing chronic critical limb ischaemia. Cardiovasc Intervent Radiol 1996; 19: 317-22. 11. London NJM, Varty K, Sayers RD, Thompson MM, Bell PRF, Bolia A. Percutaneous transluminal angioplasty for lower limb critical ischaemia. Br J Surg 1995; 82: 1232-5.

Ann R Coll Surg Engl 2002; 84