Evidence suggests that the likely cause of many medicolegal claims is failure to explain accurately risks and benefits and surgical options during the consent process (1, 2). Forty-eight percent of successful claims in the UK have been shown to be related to varicose vein surgery (1). The aim of this study was to review the incidence of complications following varicose vein intervention (open and endovenous) and to analyse the link with the consent process for these patients.

Retrospective analysis of clinical notes for all consecutive patients who underwent varicose vein surgery by open or endovenous laser therapy (EVLT) between 01/01/2019 and 31/06/2021 at the Leeds Vascular Institute, LTHT. Review of case notes and outpatient letters via PPM+, the Electronic Patient Records platform in use at the Trust, was conducted. Written approval from Clinical Governance and Caldicott Guardian was obtained. Data on postoperative complications was collected and linked with the consent process. Readmission within 30 days and presence of consultant follow-up were also recorded and analysed.

A total of 315 patients underwent varicose vein treatment either via open surgery (n=196, 62%) or EVLT (n=119, 38%). A scanned copy of the consent form was found in the patients' electronic records in 40% of the cases. For 77% of the patients a discussion of risks and benefit of procedure was documented in the preoperative clinic letter. One patient - in the EVLT group - developed a deep vein thrombosis 5 days after the procedure. Ultrasound confirmed a thrombus extending from the short saphenous vein through the sapheno-popliteal junction and into the popliteal vein for 2 cm, The patient was at high risk of DVT (Obese, antiphospholipid syndrome and personal history of DVT) and was consented for this risk pre-procedure. To minimise the risk of DVT the patient was started on Enoxaparin Sodium 40mg 12-hourly 6 hours post procedure and was advised to continue for 6 weeks. In addition, compression hosiery was provided to be worn for 2 weeks. None of the patients developed a post-operative Pulmonary Embolism (PE). A total of 8 wound infections were reported: all occurred in the open surgery group and all the patients were consented for this complication. Thirteen patients in the open surgery group complained of numbness postoperatively and 12 of them had documented evidence of this risk on the consent form. In the EVLT group, 4 patients reported this complication and for 3 of them this risk was documented in the notes. A total of 3 patients were re-admitted to hospital within 30 days. Two of them developed a wound infection and collection requiring drainage 3- and 7- days post operation respectively. One patient developed a lower limb weakness requiring Neurology input. This event was subsequently deemed unrelated to the surgery. Bruising was reported by 22 patients who received open surgery and 5 who received EVLT: this risk was mentioned in the notes in 10 and 2 cases respectively. Skin discolouration occurred in 3 patients post EVLT: all of them were consented for this risk. No patients complained of skin burns. Residual veins were reported by 21 patients post open procedure and 17 patients post EVLT. According to the clinical notes, 10 patients per group were explained this risk. Five patients (4 open, 1 EVLT) complained of the appearance of new spider veins: for none of them this risk was documented in the notes. There were no major vascular injuries reported. Routine post-operative follow up was organised for 55% of the patients undergone open surgery (56% face-to-face and 44% telephone) and 80% of patients undergone EVLT (84% face-to-face and 16% telephone).

The move towards telephone consultations post discharge may have led to under reporting of the minor complications. By contrast, readmissions and venous thromboembolism would have been recorded in the digital records. The majority of patients who developed a complication had documented evidence of the relevant risks being discussed prior to intervention. Discussion of complications of residual veins and recurrent spider veins were not well documented. In conclusion thorough documentation of risks and benefits and accurate record-keeping is paramount. As the Health Care System digitalises, it is crucial that paper notes are made available in the patients' electronic records in a timely manner.

1) Markides GA, Subar D and Al-Khaffaf H. Litigation Claims in Vascular Surgery in the United Kingdom's NHS. Eur J Vasc Endovasc Surg 2008; 36: 452-457 2) Campbell WB, France F and Goodwin HM, on behalf of the Research and Audit Committee of the Vascular Surgical Society of Great Britain and Ireland. Medicolegal claims in vascular surgery. Ann R Coll Surg Engl 2002; 84: 181-184