VASCULAR COMPLICATIONS FOLLOWING ELECTIVE MAJOR ORTHOPAEDIC SURGERY IN ROUTINE PRACTICE: THE PROSPECTIVE COHORT ESMOS STUDY.

Abstract

Background: Data on thromboembolic complications (TEC) following major orthopaedic surgery are generally obtained retrospectively from registries or prospectively from large industry-sponsored international multicentre trials. However, the results may differ from those observed in unselected patients in routine operations performed by orthopaedic surgeons. The purpose of the ESMOS study was to describe the number and time of onset of serious symptomatic arterial and venous TEC within 90 days after surgery in an unselected population of patients undergoing total hip replacement (THR).

Patients and methods: A total of 500 (430 primary THR and 70 revision THR) consecutive patients were included in the study performed between January 2004 and May 2005 in Frederiksborg County (Denmark). They were to be followed for 90 days after surgery. Patients were interviewed before surgery for medical history and on days 5 (while in hospital) and 90 (by telephone call) for signs and symptoms of acute myocardial infarction (AMI), pulmonary embolism (PE), deep-vein thrombosis (DVT), transitory cerebral ischemia (TCI)/stroke and retinal vein thrombosis (RVT). The validity of the events was confirmed using files from hospital, general practitioner and international criteria.

Results: Overall, 498 patients were followed-up for 90 days, 2 patients having withdrawn consent. In-hospital pharmacological thromboprophylaxis was performed in 499 patients. Twenty-four patients (4.8%) experienced at least one serious TEC up to day 90: 2 (0.4%) patients died from surgical-related complications (no autopsy was performed); 1 (0.2%) patient experienced AMI, 5 (1.0%) had PE, 10 (2.0%) DVT, 4 (0.8%) TCI, and 2 (0.4%) RVT. Moreover, 2 patients experienced two TEC: AMI followed by TCI in a first patient, PE and TCI in a second patient. The first event occurred up to day 5 in 9 patients (38%) and after day 5 in 15 patients (62%). Five patients (1%) had clinically relevant bleeding complications: 3 patients had a single, minor, upper gastrointestinal bleeding episode while in hospital, one patient developed a huge expanding haematoma at the operation site treated with hip spica and another patient a peritoneal haematoma leading to re-operation.

Conclusion: This study performed in an unselected population clearly shows that THR still results in serious TEC in spite of a wide use of modern anaesthesia techniques, thrombosis prophylaxis and early mobilisation. In the future, we need to better identify at-risk patients in order to optimise their management, in particular post-discharge care, and reduce the risk of serious TEC.