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Impact Of The Venovalve On Patients With Primary And Thrombotic Deep Venous Reflux
Cassius Iyad Ochoa Chaar, MD, MPH, MS1, Eric Hager, MD
2, Eric Peden, MD
3, Nani Longwolf, MD
4, Matthew R. Smeds, MD
5.
1Yale School of medicine, new haven, CT, USA,
2University of Pittsburgh Medical Center, Pittsburgh, PA, USA,
3Houston Methodist Hospital, Houston, TX, USA,
4University of Utah, Utah, UT, USA,
5Saint Louis University, Saint Louis, MO, USA.
OBJECTIVES: The VenoValve is a novel bioprosthetic valve surgically implanted into the femoral vein for patients with deep venous reflux (DVR). This study compares the outcomes of the VenoValve in patients with thrombotic DVR and primary DVR.
METHODS: SAVVE is a prospective, multicenter trial evaluating the VenoValve in patients with DVR and advanced venous disease (CEAP C4b-6). Follow up includes clinical assessment and ultrasound. Clinically meaningful improvement is defined as a decrease in venous clinical severity score (VCSS) of at least 3 points. Patients were determined to be thrombotic if they had history of venous thromboembolism and compared to patients with primary DVR based on the absence of such history.
RESULTS: There were 75 patients enrolled and 78.7% (N=59/75) had thrombotic DVR. There was no clinically significant difference in age (thrombotic=62.8 vs primary=63.5) or BMI (thrombotic=32.4 vs primary=32) between the 2 groups. However, patients with thrombotic DVR seemed to be less likely to be male (thrombotic=79.7% vs primary=87.5%) and white (thrombotic=83.1% vs primary=100%). Both groups had similar proportion of patients with active ulcers (CEAP C6 disease) (thrombotic=59.3% vs primary=56.3%) but patients in the thrombotic group were more likely to have ulceration for more than one year duration compared to primary DVR (thrombotic=80% vs primary=55%). Overall, 84% of patients had clinically meaningful improvement with mean decrease of 8.1 in VCSS. The average percentage decrease in DVR time in all patients was 17% and 21.4% at 6 months and 12 months respectively. The average change in reflux in the thrombotic patients was 7% at 6 months and 17% at 12 months. However, patients with primary DVR had 47% reduction in reflux at 6 months and 33% at 12 months. In all patients with baseline VCSS≥10, 95% of the patients demonstrated VCSS improvement at 6 months and 93% at 12 months. For the primary DVR cohort, 100% demonstrated improvement at 6 months and 12 months compared to 94% and 91% in the thrombotic cohort, respectively.
CONCLUSIONS:Most patients with advanced venous disease experienced clinically meaningful improvement at 12 months after VenoValve implantation with significant decrease in mean VCSS score. This study highlights the complexity of thrombotic patients in regard to medical care and evaluation. Reflux evaluation alone in thrombotic patients may not correlate with clinical improvement.
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