Safety and Effectiveness of Inferior Vena Cava Filters Used to Protect Against Pulmonary Embolus: A Technology Assessment

Judith Walsh, MD, MPH

CTAF

Abstract and Introduction

Introduction

The California Technology Assessment Forum (CTAF) is requested to review the scientific evidence for the safety and efficacy of the use of inferior vena cava (IVC) filters for the prevention of pulmonary embolus (PE). This review was prompted by the Food and Drug Administration (FDA) warning published in August, 2010. Since 2005, the FDA has received a fair number of device adverse reports, some of which led to adverse clinical outcomes in patients. Initially all filters were placed permanently, but more recently filters have been developed that can be placed when needed and then removed once a patient's risk for PE has decreased. Due to concern that retrievable IVC filters which are intended for short term placement, are not always removed once a patient's risk for PE subsides. The FDA recommended that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed.

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Cite this: Safety and Effectiveness of Inferior Vena Cava Filters Used to Protect Against Pulmonary Embolus: A Technology Assessment - Medscape - Feb 01, 2011.

Table 1. Retrospective studies of IVC filters and safety and efficacy outcomes
Study	N	Type of study	Treatment	Reasons for insertion	Outcomes Evaluated
Nicholson, 2010²⁸	80	Retrospective single center cross sectional	Bard Retrievable Vena Cava Filter	22% trauma 22% DVT/PE 6% Warfarin intolerance 26% Surgery prophylaxis 3% Malignant neoplasm prophylaxis 23% Unknown	Strut fracture with embolization
Ray, 2006¹³	197	Retrospective multi-center	Gunther Tulip Filter (73%) Recover filter (28%)	52% prophylaxis 34%anticoagulation contraindication 6% anticoagulation complication 6% poor cardiopulmonary reserve 2% anticoagulation failure	Safety and efficacy of placement and retrieval Retrieval rates Reasons for failure of retrieval
Millward, 1991¹⁴	64	Retrospective multi-center	LG-medical Vena Tech Vena Cava filter	36% PE with contraindication to anticoagulation 56% DVT with contraindication to anticoagulation 8% Recurrent PE on anticoagulation	Safety and efficacy of filter placement
Keller, 2007¹⁵	172	Retrospective	Gunther tulip or OptEase filter	65% prophylactic multiple trauma 2% prophylactic neurosurgery 9% proximal DVT or PE and trauma 27% proven DVT or PE and neurosurgery or other singular indications	Safety and efficacy of two filters
Hammond, 2009¹⁶	507	Retrospective audit of three centers	74% retrievable filters	57% for "absolute indications" (thromboembolism with a contraindication to anticoagulation or recurrent thromboembolism despite adequate anticoagulation) 65 for perioperative or post-traumatic prophylaxis 37% for relative indications (proximal thrombus, massive PE and multiple PE with limited cardiopulmonary reserve	Tends in IVC filter use Complications Rates of removal
Yavuz, 2008¹⁷	67	Retrospective Single center	Insertion and retrieval of 72 filters in 67 patients	31% Contraindication to anticoagulation with documented VTE 9% complication of anticoagulant therapy with documented VTE 55% prophylaxis without current VTE 3% prophylaxis with VTE in addition to anticoagulation 1% in association with pharmacomechanical thrombectomy for VTE	VTE after retrieval of IVC filter VTE after filter removal Placement of subsequent filter or death
Kim, 2008¹⁸	702	Retrospective cohort	Optease Gunther Tulip Bard Recovery TrapEase Vena Tech Greenfield Birds nest	58% Contraindication to anticoagulation 17% primary prophylaxis 1% anticoagulation complication 12% anticoagulation failure 3% catheter directed thrombolysis	PE Complication rates
Piano, 2007¹⁹	59	Retrospective	Retrievable VCF	Super obese patients undergoing bariatric surgery	Retrieval success Procedure related complications Pulmonary embolism
Ghanim, 2007²⁰	175	Retrospective cohort	Filters vs. anticoagulation alone	Neurosurgical patients	Mortality
Kalva, 2006²¹	751	Retrospective cohort	Trap Ease Vena Cava Filter	70% PE and or DVT 30% no VTE	Safety and efficacy of TrapEAse vena cava filter
Greenfield, 2003²⁷	175	Review of VCF registry	Greenfield filters	Patient with sepsis	Adverse outcomes Survival Reasons for filter removal
Mohan, 1995²²	195	Retrospective Comparative efficacy and complications of VC filters	Greenfield Vena-Tech Birds Nest Simon Nitinol	31% contraindication to anticoagulation 23% complication of anticoagulation 13% failure of anticoagulation 16% prophylaxis 3% other	Comparison of efficacy and complication rates of different filters
Phelan, 2009²³	188 52% had follow-up)	Retrospective	Any permanent prophylactic vena cava filter	High risk trauma patients	Safety and efficacy of IVC filters
McKenzie, 2010²⁹	121	Retrospective single center	Retrievable IVC filters	Established VTE and contraindication to anticoagulation 39% High risk of VTE and need for surgery with high risk of VTE and bleeding 43% Anticoagulation failure 12% Massive PE 4% Multitrauma 2%	Safety and efficacy of IVC filters and Retrieval success
Neuerburg, 1997²⁴	83	Retrospective multi-center	Retrievable Tulip Vena Cava Filter	Anticoagulation failure 30% Contraindication to anticoagulation 10% Free floating thrombus 39% Prophylaxis 1a% Other 11%	Evaluate safety and efficacy of tulip Filter
Karmy-jones, 2007²⁵	446	Retrospective multi-center	Retrievable vena cava filters	Trauma patients (97.5% for prophylaxis)	Major complications Reasons for failure to retrieve
Schutzer, 2003²⁶	189	Retrospective single center	TrapEase IVC filter	Contraindication to anticoagulation (59%) VTE on anticoagulation 11% Free floating DVT 7% Propagation of DVT 3% Prophylactic 3% Miscellaneous) 18%	Safety and efficacy
Lam, 2004³⁰	13	Retrospective single center	Gunther tulip or OptEase	Contraindication to anticoagulation (62%) Prophylaxis (38%)	Success of filter placement and retrieval Recurrent PE

Table 2. Prospective studies of IVC filters and safety/efficacy outcomes
Study	N	Design	Inclusion Criteria	Average Length of follow-up	Outcomes Evaluated	Results	Comments
OBSERVATIONAL STUDIES
Yazu, 2000³¹	42	Prospective observational	Contraindication to anticoagulation, recurrent VTE on anticoagulation, other prophylactic purposes	35 months	Complications	5% developed symptomatic PE 5% developed asymptomatic PE PE is 16.7% of those who did not receive anticoagulation and 7.4% of those who received anticoagulation	Lowe rates of PE and filter captured thrombus in those on concurrent anticoagulation
Johnson, 2010³²	100	Prospective single arm clinical trial evaluating safety and effectiveness of retrievable option IVC filer	Pulmonary thromboembolism when anticoagulation is contraindicated, failure of anticoagulant therapy in thromboembolic disease (TED), complication of anticoagulation therapy for TED or indication for temporary filter (bariatric surgery or trauma)	180 days For those who had filter removed 30 days after filter removal	"Clinical success"- technical success without subsequent PE, significant filter migration or embolization, symptomatic cava thrombosis or other complications	8 cases of recurrent PE, two cases of filter migration, no filter embolization or fracture Clinical success in 88% of participants 39 subjects had attempted Retrieval successful for 92% patients at a mean of 67 days 17 deaths and 18 DVT were judged not related to filter	No comparison group
Imberti, 2005⁸	30	Prospective observational multi-center of ALN retrievable IVC filter	VTE with a contraindication to anticoagulation, primary prophylaxis after major trauma or before surgery in patients with high thromboembolic risk	18.2 months	Efficacy and likelihood of filter removal	3 cases of trapped emboli in filter 1 case asymptomatic filter migration toward heart 2 DVT recurrences ALN removal attempted in 18 patients and successful in 78% Retrieval less successful more than 3 months after implantation Median implantation 123 days	Retrieval safe and efficacious after medium period of placement Retrieval more than three months after placement less successful
Ziegler, 2008³³	150	Post-marketing surveillance; multicenter prospective of OptEase IVC filter as permanent filter	PE with anticoagulation contraindicated; anticoagulation failure, emergency treatment after massive PE, chronic and or recurrent PE where anticoagulation failed or was contraindicated and patients at high risk for PE with relative or absolute contraindication to anticoagulation	Six months	Primary endpoints: filter migration and symptomatic thrombosis one month after implantation Secondary endpoints: major adverse events, filter tilting	At one month 0.9% filter migration and 0.9% filter thrombosis No new filter migration or symptomatic thrombosis at 6 months	55 out of 150 did not complete full six month evaluation
Bovyn, 2006³⁴	103	Multicenter prospective study of patients receiving Tempofilter II	Complications of or contraindications to anticoagulation therapy, ineffectiveness of anticoagulation therapy or prophylactic (high risk surgery or free floating thrombus)	90 days	Rate of retrieval Filter related complications PE	Filter in place for a mean of 29.5 days All filters except one were removed One episode of filter migration followed by PE	Filter retrieval successful when filter in place for relatively short period
Ricco, 1995⁴¹	222	Multicenter prospective	PE on anticoagulation PE with contraindication to anticoagulation PE and ileocaval thrombosis Ileocaval/femoral or popliteal thrombosis Thrombosis without embolism Cor pulmonale with lower extremity thrombosis	15 months	Local complications General complications	1.7% 30 day mortality 2.2% recurrent PE 3.6% filter migration Two recurrent PE Seven caval thromboses
Mismetti, 2007³⁶	220	Single center prospective cohort of patients with retrievable VCF	Recurrent VTE despite anticoagulation, transient bleeding event, definite contraindication to anticoagulation or need to stop anticoagulation due to major surgery trauma or invasive procedure	18 months	Success of filter insertion Clinical events related to filter insertion Filter retrieval	Filter insertion 98.6% successful Complication of filter placement 11.8% Median duration of filter placement 166 days At least one VTE 17% Removal successful at first attempt in 92.7% of patients	Largest multicenter study of single type of retrievable filter
Greenfield, 1991³⁷	186	Prospective multi-center study of modified hook-titanium Greenfield filter	Contraindication to anticoagulation Free floating thrombus, anticoagulation complication Anticoagulation failure Recurrent embolism with pulmonary hypertension Massive embolism requiring vasopressors	30 day	Safety and efficacy	97% filter placement success 22 deaths from PE 9.75 new lower extremity edema No filter occlusion	Study goal was to evaluate modified filter
TRIALS
Fullen, 1973 J or Trauma 1973;13: 403–10)³⁸	129	Single center trial Participants received permanent cava filter or no filter	Proximal femoral fracture	33 days	Mortality PE Filter insertion complications	No difference in mortality Fewer PE in filter group (RR 0.3; 95% C.I. 0.11,.0.82)	No information on long term complications
Decousus, 1998³⁹; PREPIC, 2005⁴²	400	Randomized controlled trial (RCT) with 2 x 2 factorial design also comparing low molecular weight heparin to unfractionated heparin	Acute DVT with or without PE and if physicians considered them to be at high risk for PE	2 year and 8 year	Recurrent VTE, death and major bleeding	At day 12, fewer PE in the filter group than in the no filter group (OR 0.22: 95% C.I. 0.05, 0.90) At two years more recurrent DVT in filter group (OR 1.87: 95% C.I. 1.10, 3.20) Similar results at one year follow up
Usoh, 2010⁴⁰	156 (N=84 Greenfield and n=72 Trapease)	Prospective randomized comparative study comparing IVC Greenfield and TrapEase filters	Contraindication to anticoagulation, or failed anticoagulation, high risk trauma patient or high risk procedure with history of VTE	12 months	Access site thrombosis Filter thrombosis Symptomatic PE	Symptomatic IVC/IV thrombosis in 6.94% in the TrapEase group and none in the Greenfield group (P=0.19) No filter migration, access site thrombosis misplacement or IVC perforation Recurrent PE suspected in one of five patients with IVC/IV thrombosis 30 day and 12 month mortality was comparable between the two groups	349 eligible patients during the time period did not participate in the study. Higher rate of IVC/IV thrombosis in those who received TrapEase- effect was not related to anticoagulation

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