Safety and Effectiveness of the Denali Inferior Vena Cava Filter

Stephen P. Reis, Jerry Kovoor, Patrick D. Sutphin, Seth Toomay, Clayton Trimmer, Anil Pillai, Mark Reddick, Sanjeeva P. Kalva

Research output: Contribution to journalReview article

4 Citations (Scopus)

Abstract

Purpose: The purpose of the study is to evaluate the clinical safety and effectiveness of the Denali (Bard, Tempe, Arizona) retrievable inferior vena cava (IVC) filter. Materials and Methods: In this retrospective study, authors reviewed the data of Denali IVC filters placed at their institution between 2013 and 2015. The clinical presentation, indications, and procedure-related complications during placement and retrieval were evaluated. The frequency of post filter pulmonary embolism (PE) and filter-related complications was assessed. Results: Denali filters were placed in 87 patients (47 males; mean age: 56 years). Twenty patients presented with PE, 45 with deep vein thrombosis (DVT), and 21 with both PE and DVT, 1 filter was placed prophylactically before surgery. Indications for filter placement included contraindications to anticoagulation (AC; n = 80), failure of AC (n = 4), and complications of AC (n = 3). No patients had PE on follow-up imaging after filter placement. Retrieval was attempted in 31 patients after a mean period of 125 days (range: 34-324 days). The filter was successfully removed in 31 (100%) patients. Follow-up imaging, available in 71 (82%) patients (range: 2-538 days), demonstrated penetration of 15 legs in 5 patients, caval thrombus in 3, 1 resulting in caval occlusion, <15° filter tilt in 5, and no leg fractures or crossed legs. Conclusion: The Denali filter is safe during deployment and readily retrievable. The overall safety following deployment is similar to those reported in the literature, and the incidence of filter fractures and migration appears to be less than the previous generation of Bard devices.

Original languageEnglish (US)
Pages (from-to)385-390
Number of pages6
JournalVascular and Endovascular Surgery
Volume50
Issue number6
DOIs
StatePublished - Aug 1 2016

Fingerprint

Vena Cava Filters
Safety
Pulmonary Embolism
Leg
Venae Cavae
Venous Thrombosis
Thrombosis
Retrospective Studies
Equipment and Supplies
Incidence

Keywords

  • DVT
  • filter complications
  • inferior vena cava filter
  • PE

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Safety and Effectiveness of the Denali Inferior Vena Cava Filter. / Reis, Stephen P.; Kovoor, Jerry; Sutphin, Patrick D.; Toomay, Seth; Trimmer, Clayton; Pillai, Anil; Reddick, Mark; Kalva, Sanjeeva P.

In: Vascular and Endovascular Surgery, Vol. 50, No. 6, 01.08.2016, p. 385-390.

Research output: Contribution to journalReview article

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abstract = "Purpose: The purpose of the study is to evaluate the clinical safety and effectiveness of the Denali (Bard, Tempe, Arizona) retrievable inferior vena cava (IVC) filter. Materials and Methods: In this retrospective study, authors reviewed the data of Denali IVC filters placed at their institution between 2013 and 2015. The clinical presentation, indications, and procedure-related complications during placement and retrieval were evaluated. The frequency of post filter pulmonary embolism (PE) and filter-related complications was assessed. Results: Denali filters were placed in 87 patients (47 males; mean age: 56 years). Twenty patients presented with PE, 45 with deep vein thrombosis (DVT), and 21 with both PE and DVT, 1 filter was placed prophylactically before surgery. Indications for filter placement included contraindications to anticoagulation (AC; n = 80), failure of AC (n = 4), and complications of AC (n = 3). No patients had PE on follow-up imaging after filter placement. Retrieval was attempted in 31 patients after a mean period of 125 days (range: 34-324 days). The filter was successfully removed in 31 (100{\%}) patients. Follow-up imaging, available in 71 (82{\%}) patients (range: 2-538 days), demonstrated penetration of 15 legs in 5 patients, caval thrombus in 3, 1 resulting in caval occlusion, <15° filter tilt in 5, and no leg fractures or crossed legs. Conclusion: The Denali filter is safe during deployment and readily retrievable. The overall safety following deployment is similar to those reported in the literature, and the incidence of filter fractures and migration appears to be less than the previous generation of Bard devices.",
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