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

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1531-1538.e1
JournalJournal of Vascular and Interventional Radiology
Volume27
Issue number10
DOIs
StatePublished - Oct 1 2016

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Vena Cava Filters
Multicenter Studies
Prospective Studies
Pulmonary Embolism
Venous Thrombosis
Venae Cavae
Clinical Trials
Safety
Incidence

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Stavropoulos, S. W., Chen, J. X., Sing, R. F., Elmasri, F., Silver, M. J., Powell, A., ... Muhs, B. E. (2016). Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter. Journal of Vascular and Interventional Radiology, 27(10), 1531-1538.e1. https://doi.org/10.1016/j.jvir.2016.06.028
Stavropoulos, S. William ; Chen, James X. ; Sing, Ronald F. ; Elmasri, Fakhir ; Silver, Mitchell J. ; Powell, Alex ; Lynch, Frank C. ; Abdel Aal, Ahmed Kamel ; Lansky, Alexandra ; Muhs, Bart E. / Analysis of the Final DENALI Trial Data : A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter. In: Journal of Vascular and Interventional Radiology. 2016 ; Vol. 27, No. 10. pp. 1531-1538.e1.
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title = "Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter",
abstract = "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.",
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Stavropoulos, SW, Chen, JX, Sing, RF, Elmasri, F, Silver, MJ, Powell, A, Lynch, FC, Abdel Aal, AK, Lansky, A & Muhs, BE 2016, 'Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter', Journal of Vascular and Interventional Radiology, vol. 27, no. 10, pp. 1531-1538.e1. https://doi.org/10.1016/j.jvir.2016.06.028

Analysis of the Final DENALI Trial Data : A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter. / Stavropoulos, S. William; Chen, James X.; Sing, Ronald F.; Elmasri, Fakhir; Silver, Mitchell J.; Powell, Alex; Lynch, Frank C.; Abdel Aal, Ahmed Kamel; Lansky, Alexandra; Muhs, Bart E.

In: Journal of Vascular and Interventional Radiology, Vol. 27, No. 10, 01.10.2016, p. 1531-1538.e1.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Analysis of the Final DENALI Trial Data

T2 - A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter

AU - Stavropoulos, S. William

AU - Chen, James X.

AU - Sing, Ronald F.

AU - Elmasri, Fakhir

AU - Silver, Mitchell J.

AU - Powell, Alex

AU - Lynch, Frank C.

AU - Abdel Aal, Ahmed Kamel

AU - Lansky, Alexandra

AU - Muhs, Bart E.

PY - 2016/10/1

Y1 - 2016/10/1

N2 - 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.

AB - 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.

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