From the American Venous Forum Prospective evaluation of the clinical deterioration in post-thrombotic limbs Nicos Labropoulos, PhD, DIC, RVT, Antonios P. Gasparis, MD, RVT, and Apostolos K. Tassiopoulos, MD, Stony Brook, New York Objective: Several studies have evaluated the natural history of deep vein thrombosis (DVT), but few have correlated the clinical progression using duplex ultrasound (DU) imaging during the first year. This study was designed to determine the relationship of changes in the venous system and correlate them with long-term progression of disease. Methods: Consecutive patients with a first episode of proximal DVT documented by DU imaging were included prospectively. Clinic examinations were performed at 3, 6, and 12 months, and yearly thereafter. The CEAP system was used to grade disease severity. DU imaging was performed at least once, 1 year after the diagnosis, and repeated at 5 years. The proximal veins were divided the common femoral vein, femoral vein, and popliteal vein segments for analysis. Thrombosed veins were subsequently graded as completely, partially, and fully recanalized. Recurrent DVT cases were also recorded. Results: The study included 64 patients with 73 involved limbs; of which, skin damage was documented in three (4%) at 1 year and in 18 (25%) at 5 years (P  0.0006; relative risk [RR], 3.92; 95% confidence interval [CI], 1.36-11.3). Overall from 1 to 5 years, 50 limbs remained the same. A change in clinical class occurred in 23 limbs (31.5%), including five limbs that progressed from class 0 to 3, 15 limbs from class 3 to 4 and 6, and three from class 4 to 5 and 6. DU imaging of these 23 limbs progression showed that the most important predictor for class progression was ipsilateral recurrent DVT (RR, 4.4; 95% CI, 1.4-13.3). Recurrent DVT at 1 year occurred in 21.9%, including ipsilateral in 15.6% and contralateral in 6.3%. Total recurrence at 5 years was 31.3%, including ipsilateral in 23.4% and contralateral in 7.8%. Limbs with ipsilateral recurrence were more likely to have partial recanalization, reflux, and more vein segments involved compared with those with contralateral recurrence or no recurrence (11 of 15 vs 16 of 58; RR, 4.7; 95% CI, 1.7-13.3). Conclusion: Clinical class progression from year 1 to 5 occurs in 30% of post-thrombotic limbs. The most important predictor for progression in clinical class was ipsilateral recurrent DVT. ( J Vasc Surg 2009;50:826-30.) Chronic venous disease (CVD) of the lower extremities is an important socioeconomic problem in industrialized societies because of its high prevalence and treatment cost. 1,2 Deep vein thrombosis (DVT) is the major cause of secondary CVD and has been strongly associated with the development of post-thrombotic syndrome (PTS). PTS can lead to significant suffering, disability, and impairment in quality of life. 3 Patients with severe PTS report a quality of life similar to those with cancer and congestive heart failure. 4,5 The incidence and severity of PTS has been correlated with the location, extent, and recurrence of DVT. 6,7 Although several natural history studies 7,8 have dem- onstrated the clinical progression of PTS over a period of time, no studies have followed the clinical and ultrasound- documented changes that occur over time. This prospec- tive study was designed to determine the progression of PTS after a first episode of acute proximal DVT and corre- late the degree of progression with duplex ultrasound (DU) findings at short- and long-term. METHODS Patients. This prospective study was performed by selecting consecutive patients with a documented episode of acute proximal DVT involving at least the popliteal vein. This was their first lower extremity thrombotic episode, which was diagnosed by duplex ultrasound (DU) imaging. Patients were treated initially with parenteral anticoagula- tion, followed by oral anticoagulation (international nor- malized ratio of 2 to 3) for a minimum of 6 months. All patients were provided and strongly encouraged to use 30- to 40- mm Hg compression stockings. A hypercoagulable workup was ordered selectively and therefore was not avail- able for all patients. Excluded were patients with a body mass index (BMI) 35 kg/m 2 , history of previous or current malignancy, short life expectancy, joint problems (fixed joint, limited range of motion), immobility (wheelchair-bound or need- ing a device to walk), inflammation (chronic infection, skin diseases, vasculitis), lymphangitis, lymphedema, CVD be- fore DVT, superficial vein thrombosis or DVT before the event in this study, and those with previous interventions in the lower leg, including venous procedures comprising stripping, ligation, ablation, phlebectomies, thrombec- tomy and thrombolysis; major trauma, and joint arthro- plasty. Excluded from the patients who were identified with thrombosis were those who had at least one of the exclusion criteria, were unable or chose not to come for their follow- From the Vascular Surgery Division, Stony Brook University Medical Center– Stony Brook. Competition of interest: none. Reprint requests: Nicos Labropoulos, Professor of Surgery and Radiology, Director, Vascular Laboratory, Department of Surgery, HSC T19 Room 91, Stony Brook University Medical Center, Stony Brook, NY 11794- 8191 (e-mail: nlabrop@yahoo.com). 0741-5214/$36.00 Copyright © 2009 by the Society for Vascular Surgery. doi:10.1016/j.jvs.2009.05.059 826