Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter.
S William Stavropoulos, James X Chen, Ronald F Sing, Fakhir Elmasri, Mitchell J Silver, Alex Powell, Frank C Lynch, Ahmed Kamel Abdel Aal, Alexandra Lansky, Bart E Muhs, DENALI Trial Investigators
Author Information
S William Stavropoulos: Division of Interventional Radiology, Department of Radiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: stav@uphs.upenn.edu.
James X Chen: Division of Interventional Radiology, Department of Radiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Ronald F Sing: Division of Surgical Critical Care, Carolinas Medical Center, Charlotte, North Carolina.
Fakhir Elmasri: Division of Interventional Radiology, Lakeland Regional Medical Center, Lakeland, Florida.
Mitchell J Silver: Division of Interventional Cardiology and Peripheral Vascular Disease, Riverside Methodist Hospital, Columbus, Ohio.
Alex Powell: Department of Radiology, Division of Interventional Radiology, Baptist Hospital, Miami, Florida.
Frank C Lynch: Division of Interventional Radiology, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.
Ahmed Kamel Abdel Aal: Department of Radiology, University of Alabama at Birmingham Medical Center, Birmingham, Alabama.
Alexandra Lansky: Division of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut.
Bart E Muhs: The Vascular Experts, Middletown, Connecticut.
PURPOSE: To report the final 2-year data on the efficacy and safety of a nitinol retrievable inferior vena cava (IVC) filter for protection against pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective multicenter trial of 200 patients with temporary indications for caval filtration who underwent implantation of the Denali IVC filter. After filter placement, all patients were followed for 2 years after placement or 30 days after filter retrieval. The primary endpoints were technical success of filter implantation in the intended location and clinical success of filter placement and retrieval. Secondary endpoints were incidence of clinically symptomatic recurrent PE, new or propagating deep vein thrombosis (DVT), and filter-related complications including migration, fracture, penetration, and tilt. RESULTS: Filter placement was technically successful in 199 patients (99.5%). Filters were clinically successful in 190 patients (95%). The rate of PE was 3% (n = 6), with 5 patients having a small subsegmental PE and 1 having a lobar PE. New or worsening DVT was noted in 26 patients (13%). Filter retrieval was attempted 125 times in 124 patients and was technically successful in 121 patients (97.6%). The mean filter dwell time at retrieval was 200.8 days (range, 5-736 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of filter retrieval or during follow-up. CONCLUSIONS: The Denali IVC filter exhibited high success rates for filter placement and retrieval while maintaining a low complication rate in this clinical trial.
