Bard Recovery Research Articles

SPIKED THROUGH THE HEART: A RARE COMPLICATION OF INFERIOR VENA CAVA (IVC) FILTER PLACEMENT

SPIKED THROUGH THE HEART: A RARE COMPLICATION OF INFERIOR VENA CAVA (IVC) FILTER PLACEMENT

Abstract No. 198 - Endovascular removal of fractured ivc filter fragments: a 5-year prospective study

To evaluate the safety and efficacy of IVC filter fragment removal during retrieval of embedded IVC filters. Over a 5-year period, 82 consecutive patients presenting with an embedded IVC filter complicated by fractured fragments were prospectively enrolled into an IRB–approved study. There were 27 men and 55 women (mean: 47 years, range: 19–85). After main filter removal, percutaneous fragment removal was attempted if deemed accessible and intravascular on pre-procedure CT and/or intraprocedure cone-beam CT (DynaCT), and distal pulmonary artery fragments were left alone. Removal of intracardiac fragments was attempted in the same session or later in conjunction with EP cardiology. Rigid forceps were used in the IVC, and cardiopulmonary fragments were approached with snares, angled catheters, curved sheaths, and intravascular ultrasound (IVUS) if needed. All data were captured using REDCap. There were 82 filters (96% placed at OSH): 23 Bard G2/G2X/Eclipse (28.1%), 12 Bard Recovery (14.6%), 3 Bard Meridian (3.7%), 1 Bard Denali (1.2%), 20 Celect (24.4%), 3 Gunther Tulip (3.7%), 2 Option (2.4%), 1 ALN (1.2%), 7 Optease (8.5%), 5 Trapease (6.1%), 2 Simon Nitinol (2.4%), 2 24-Fr Greenfield (2.4%), 1 Titanium Greenfield (1.2%). Mean dwell time was 2183 days, range: 59-9936 days. 185 fragments were identified (83 IVC, 34 PA, 15 cardiac, 2 hepatic vein, 1 renal vein, 1 aorta, 50 extraluminal) and 5(5.7%) embolized during the procedure (3 PA, 1 RA, 1 HV). 87/185 (47%) were deemed amenable to attempted removal: 65 IVC, 11 PA, 8 cardiac, 2 hepatic, 1 aortic. Adjunctive DynaCT was used in 10 and intracardiac IVUS in 2. Removal was successful in 78/87(89.7%) (95%CI:83.3-96.1). Among 9 failures, 4 fragments were embedded in PA, 2 in RA, 2 in RV, 1 in HV. There was 1 major complication (1.1%) (95%CI:0.0-3.3%), cardiac tamponade during attempted RV fragment removal, successfully treated with pericardial drain. The complication rate from attempted cardiac fragment removal was 1/8(12.5%) (95%CI:0.0-34.4%). Percutaneous removal of filter fragments from the IVC and pulmonary arteries is overall safe and effective, but intracardiac fragment removal carries a higher risk of complications.

Abstract No. 294 - Positional changes of retrievable inferior vena cava (IVC) filters at the time of removal: a comparative study of different filter types

Retrospective study of positional changes of retrievable IVC filters between insertion and removal. The following parameters were recorded: changes in tilt angle, filter position and strut penetration. Retrospective review of the PACS at an academic medical center, was performed for IVC filter retrieval attempts from Jan 1 2010 to Dec 30 2012 identified 337 cases. Demographic information, insertion and retrieval parameters, and filters types were documented. Images were reviewed and the tilt and migration of the filters were measured from venograms performed post insertion and pre removal. Penetration of struts through the vessel wall was measured. Patients in which imaging was inadequate were excluded, leaving 262 patients in the final study group. 262 filter retrievals were identified. 5 filter types were recorded: Cook Celect filter (187), Bard Recovery family (33), ALN (27), Cordis Optease (8), Cook Tulip (7)Comparative average values of filter tilt relative to IVC long axis, migration, and vessel wall penetration for the different brands are presented in the table. For the parameters measured, all filter types demonstrated similar changes in filter tilt, migration and penetration at the time of removal. To our knowledge this is the largest dataset of IVC filter retrieval comparing multiple filter types. We have measured IVC filter tilt, migration and strut penetration changes that occured between insertion and removal parameters that may influence the overall success of the retrieval procedure. Although no filter type is clearly superior to the others, each type has its own characteristics that should be taken into account at the time of insertion. This comparative data does not allow a determination of the superiority of any one filter.

Successful Retrieval from Right Ventricular Wall of an Embolized Bard Meridian Filter Fragment

In recent years, earlier generations of Bard Peripheral Vascular (Tempe, Arizona) retrievable inferior vena cava (IVC) filters have been documented to fracture and embolize, with serious complications ( 1 Tam M.D. Spain J. Lieber M. Geisinger M. Sands M.J. Wang W. Fracture and distant migration of the Bard Recovery filter: a retrospective review of 363 implantations for potentially life-threatening complications. J Vasc Interv Radiol. 2012; 23: 199-205 Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar , 2 Nicholson W. Nicholson W.J. Tolerico P. et al. Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade. Arch Intern Med. 2010; 170: 1827-1831 Crossref PubMed Scopus (167) Google Scholar ). Filter designs have since been modified, including the addition of an electropolished finish and caudal anchors to reduce migration. Here we describe a case of an implanted Bard Meridian filter with spontaneous fracture of two of its limbs before attempted retrieval. One limb was found embedded within the patient’s right ventricle, requiring meticulous removal.

Modified Loop Snare Technique for the Removal of Bard Recovery, G2, G2 Express, and Eclipse Inferior Vena Cava Filters

The present work describes the preliminary results of the use of a novel technique for the removal of tilted and apex-embedded Recovery, G2, G2 Express, and Eclipse inferior vena cava filters. A retrospective review was performed of 33 filters removed in 32 patients by using the described modified loop snare technique. All filters were successfully removed with the use of the technique. The average duration of filter implantation for the devices removed with the technique was 556 days (range, 11-2,437 d; median, 268 d). No filter fractures occurred related to the removal technique. No procedure-related complications occurred.

Abstract No. 57 Modified loop snare technique for the removal of Bard Recovery, G2, G2 Express and Eclipse inferior vena cava filters

Abstract No. 57 Modified loop snare technique for the removal of Bard Recovery, G2, G2 Express and Eclipse inferior vena cava filters

Refrain, Recover, Replace

In this issue of Journal of Vascular Interventional Radiology, two articles address the removal of fractured retrievable vena cava filters after prolonged dwell times ( 1 Dinglasan L.A.V. Trerotola S.O. Shlansky-Goldberg R.D. Mondschein J. Stavropoulos S.W. Removal of fractured inferior vena cava filters: feasibility and outcomes. J Vasc Interv Radiol. 2012; 23: 181-187 Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar , 2 Vijay K. Huges J.A. Burdette A.S. et al. Fractured Bard Recovery, G2, and G2 express inferior vena cava filters: incidence, clinical consequences, and outcomes of removal attempt. J Vasc Interv Radiol. 2012; 23: 188-194 Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar ). Both of these articles shed light on the next steps in the management of fractured vena cava filters. As is often the case when business and legal implications cloud the waters of clinical practice, scientific reporting lends clarity to physicians and patients facing daunting treatment decisions. The two main issues that continue to challenge physicians and patients who have received a retrievable filter are as follows: (i) Is the filter durable over a prolonged time? (ii) If it is not durable, can it be removed safely years after its implantation? Fractured Bard Recovery, G2, and G2 Express Inferior Vena Cava Filters: Incidence, Clinical Consequences, and Outcomes of Removal AttemptsJournal of Vascular and Interventional RadiologyVol. 23Issue 2PreviewTo increase the understanding of risks of inferior vena cava (IVC) filter fracture and embolization and the safety of removing fractured filters via retrospective review of a prospectively collected database of fractured IVC filters. Full-Text PDF Removal of Fractured Inferior Vena Cava Filters: Feasibility and OutcomesJournal of Vascular and Interventional RadiologyVol. 23Issue 2PreviewTo examine the feasibility and outcomes of removing retrievable inferior vena cava (IVC) filters that have fractured. Full-Text PDF

Fracture and Distant Migration of the Bard Recovery Filter: A Retrospective Review of 363 Implantations for Potentially Life-Threatening Complications

Purpose To report the occurrence of fracture of the Recovery filter and incidence of potentially life-threatening complications associated with fractured fragment migration. Materials and Methods A retrospective study of images obtained after placement of Recovery inferior vena cava (IVC) filters from 2003 to 2006 was conducted at a single tertiary-care center. Images were reevaluated for fracture and migration; complications related to filter fracture were investigated. Kaplan–Meier survival analysis was performed to investigate the relationship between time in situ and fracture. Results A total of 363 Recovery filters were placed; 97 were retrieved, leaving 266 filters in situ (135 patients subsequently died of other causes). The following images were evaluated: 130 chest computed tomography (CT) scans, 153 abdominal CT scans, 254 chest radiographs, 148 radiographs of the abdomen/pelvis, and 106 cavagrams. Mean imaging follow-up interval was 18.4 months (maximum, 81.3 mo). No en bloc migration occurred outside the IVC. Twenty-six limb fractures (all short limbs) were identified in 20 patients; the earliest occurred at 4.1 months. Eight fragment migrations occurred into pulmonary arteries, seven into iliac/femoral veins, one into the right ventricle, and one into the renal vein. Seven fragments were intracaval near the filter, one was extracaval, and one could not be located. Kaplan–Meier survival estimates predicted a fracture rate of 40% at 5.5 years. Of the 20 patients with filter fractures, three died of unrelated causes and 17 remain asymptomatic. Conclusions Recovery filter fractures occurred at the short limb only, with a suggested 5.5-year fracture risk of 40%. No life-threatening events occurred in patients with filter fracture.

Fractured Bard Recovery, G2, and G2 Express Inferior Vena Cava Filters: Incidence, Clinical Consequences, and Outcomes of Removal Attempts

To increase the understanding of risks of inferior vena cava (IVC) filter fracture and embolization and the safety of removing fractured filters via retrospective review of a prospectively collected database of fractured IVC filters. A total of 63 fractured IVC filters were discovered among 548 patients presenting for retrievable filter removal between April 2004 and November 2010 at a single institution. Device type, duration of implantation, component fracture, and embolization events were recorded. Success rates and techniques for removal of components were recorded. A total of 63 fractured Recovery, G2, and G2 Express IVC filters were identified, for an overall fracture rate of 12%. Excluding foot process fractures, the fracture rate for only filter arms and/or legs was 6%. The incidence of fracture increased with longer filter dwell times. Success rates for removal of the nonfractured component (ie, main body) and fractured components (ie, arm or leg) were 98.4% and 53.4%, respectively. The distal embolization rate of fractured filter components was 13%. There were no immediate clinically significant complications associated with fracture component embolization or filter removal. A single patient was encountered with symptoms related to their fractured filter. IVC filter fracture rates increase with longer dwell times; however, removal of fractured filters and fractured components (ie, arms and legs) can be achieved safely and effectively. Clinically significant complications of IVC filter fracture are rare, and there were no immediate clinical sequelae related to embolization of fracture components.

Abstract No. 108: Fracture and distal migration of the Bard Recovery filter: A retrospective study with follow-up of 363 patients from 2003 to 2010

Abstract No. 108: Fracture and distal migration of the Bard Recovery filter: A retrospective study with follow-up of 363 patients from 2003 to 2010

Long-Term Outcome of Inferior Vena Cava Filter Placement in Patients Undergoing Gastric Bypass

It has been well established that inferior vena cava (IVC) filter placement at the time of open gastric bypass (OGB) surgery in patients with a body mass index of more than 55 kg/m(2) reduces both the pulmonary embolism rate and the perioperative mortality. However, little is known about the long-term effects of IVC filter placement in this particular group of patients. Over an 8-year period, a total of 571 morbid obese patients underwent OGB procedures, and 58 (10%) of them required placement of an IVC filter before their procedure. All IVC filters were placed percutaneously through a femoral vein approach using a portable OEC fluoroscope. Types of IVC filters used in our study included the TrapEase (n = 35), Simon-Nitinol (n = 9), Greenfield (n = 2), and Bard Recovery (n = 12). Of the 58 patients who required an IVC placement, 56 remained free of any thromboembolic phenomena over the 8-year period (range, 1-8 years). The remaining two patients developed deep venous thrombosis. One patient was successfully treated with intravenous heparin and a 6-month course of Coumadin. She had complete resolution of her deep venous thrombosis and was incidentally noted to have a prothrombin 20210 gene mutation. The other patient, who had multiple gastric bypass complications, could not be successfully treated with intravenous heparin and thus progressed on to complete IVC thrombosis. She developed phlegmasia cerulea dolens and required bilateral above-the-knee amputations. She subsequently died 3 months after her procedures. It appears that IVC filter placement at the time of OGB surgery is a relatively benign intervention with a maximal benefit. A note of caution should be exerted for those obese patients who have a hypercoagulable disorder and for those who have complications related to the gastric bypass. An aggressive posture, which may consist of immediate anticoagulation after their procedures (only when it is deemed safe), should be advocated in this small sub-group of morbid obese patients.

Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade

Vena cava filters represent an alternative treatment option for patients with contraindications to anticoagulation, or they might serve as adjunctive treatment for continued emboli despite anticoagulation. The fracture of a filter strut with subsequent end-organ embolization is a rarely reported but potentially life-threatening occurrence. We sought to determine the prevalence of fracture and embolization of the Bard Recovery (first generation) and the Bard G2 (second generation) vena cava filters. A retrospective, single-center, cross-sectional study was conducted by evaluating all patients who received either a Bard Recovery or Bard G2 filter from April 2004 until January 2009. A total of 189 patients had undergone implantation: 1 pregnant woman and 35 patients who died were excluded from our study. In addition, 10 patients who had the filter removed were also excluded. Ultimately, 80 patients participated in the trial. Subjects underwent fluoroscopy to assess the filter's integrity. Embolized struts were localized by fluoroscopy. Echocardiography and cardiac computed tomography were performed in patients with fragment embolization to the heart. Thirteen of 80 patients had at least 1 strut fracture (16%). At least 1 strut in 7 of the 28 Bard Recovery filters fractured and embolized (25%). In 5 of these 7 cases, patients had at least 1 fragment embolize to the heart (71%). Three patients experienced life-threatening symptoms of ventricular tachycardia and/or tamponade, including 1 patient who experienced sudden death at home. Six of 52 Bard G2 filters fractured (12%). In 2 of these 6 cases, the patients had asymptomatic end-organ fragment embolization. The Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening sequelae.

Abstract No. 2: Complications of the Bard Recovery filter and their effect on attempted retrieval in 107 patients

Abstract No. 2: Complications of the Bard Recovery filter and their effect on attempted retrieval in 107 patients

Complications Related to Inferior Vena Cava Filters: A Single-Center Experience

We reviewed our experience with the different types of inferior vena cava (IVC) filters used over 4 years for the incidence of complications and correlated this with the type of filter used. This is a retrospective study involving chart reviews of all the patients who received IVC filters placed between January 2002 and January 2006. Data related to indications for filter insertion and the incidence of early (30 days) and late complications related to the filter insertion were collected. Complications were correlated to the type of filter and the indication for insertion. Statistical analysis was done using Fisher's exact test, and p<0.05 was considered significant. During this period 400 filters were inserted. There were 199 males (49.7%) and 201 females (50.25%). The mean patient age was 61 years (range 17-86). Filters used included TrapEase in 224 (56%), Greenfield filter in 95 (23.8%), Gunther-Tulip in 42 (10.5%), Bard recovery nitinol (all first-generation) in 34 (8.5%), and Simon Nitinol filter in five (1.2%). The indications for IVC filter insertion included acute venous thromboembolism (VTE) event in 273 patients (68.25%) and pulmonary embolism (PE) prophylaxis in 127 (31.75%) patients. In the group with VTE, 59 (21.6%) had contraindication for anticoagulation and 34 (12.5%) had hypercoagulable/malignant conditions. In the 127 patients who received the filter for PE prophylaxis in the absence of VTE, 107 (84.3%) had fractures, 43 (33.9%) had head injury, 32 (25.2%) had multiple trauma, and 15 (11.8%) had paralysis. Sixteen (12.6%) of the prophylaxis patients had IVC filter insertion prior to an elective surgical procedure. Complications in the form of hematoma at the site of filter insertion occurred in four (1%) patients, ipsilateral limb deep vein thrombosis in 15 (3.8%) patients, migration/tilt of filter in six (1.5%) patients, PE in six (1.5%) patients, and IVC thrombosis in 19 (4.75%) patients. Migration/tilt was higher in Bard filters compared to other filters, individually (p<0.004) and as a group (11.8% vs. 0.55%, p<0.0005). All other complication had a comparable incidence in all filters. However, in the group of patients (n=34) who had hypercoagulable/malignant conditions, the incidence of IVC thrombosis was higher with TrapEase filters compared to all other filters as a group (25% vs. 0%, p<0.05). In conclusion, IVC filters are frequently used for prophylaxis in the absence of VTE conditions. Complications are relatively low. All types of filters used in this study had comparable complications with the exception of the Bard filter, which had a higher incidence of tilt, and the TrapEase filter, which had a higher incidence of IVC thrombosis, in patients with hypercoagulable/malignant conditions.

Balloon-assisted Removal of Tilted Inferior Vena Cava Filters with Embedded Tips

The successful removal of most retrievable inferior vena cava (IVC) filters requires the capture of the filter apex. The severely tilted filter with an apex in contact with the caval wall and covered by an endothelial cap represents a major technical challenge to removal. While a variety of techniques to deal with this problem have been reported, most require complex wire manipulations or the use of rigid endobronchial forceps. This article describes the successful use of a standard angioplasty balloon to free the apex of severely tilted filters with endothelial apical caps. A retrospective review of those patients who presented for removal of their Bard Recovery or G2 IVC filter between June 2005 and August 2008 was performed. Imaging studies and medical records were reviewed for those patients who had their IVC filters removed using the balloon-assisted technique. The presence of filter tilt and movement as well as the outcome of the technique was recorded for each case. Forty-eight Recovery and 209 G2 filters presented for removal. Ten of these 257 filters (3.6%) were found to be severely tilted with filter apex embedded into the wall of the cava. Eight of these filters were successfully removed using the balloon-assisted technique. No complications resulting from the technique occurred. Balloon-assisted removal of severely tilted embedded G2 and Recovery filters is an effective technique that can be performed using tools commonly available and familiar to most interventionists.

Bard Recovery Filter: Evaluation and Management of Vena Cava Limb Perforation, Fracture, and Migration

To report on the evaluation and management of Bard Recovery filter limb perforation, fracture, and migration. In 2007, all patients who received a Bard Recovery filter at a single institution were contacted for consultation and evaluation by noncontrast computed tomography. Rates of limb perforation, fracture, and migration were evaluated on early (<180 days) and final images. Retrieval success and complications were evaluated. Fourteen of 16 patients with Bard Recovery filters were evaluated. The early images in nine patients (mean, 30 days; range, 0-126 d +/- 40) demonstrated arm perforations in 56% (n = 5), leg perforation in 11% (n = 1), and no early fractures or migrations. Final images (mean, 899 days; range, 119-1,218 d +/- 320) demonstrated filter arm perforations in all 14 patients. Leg perforations were seen in 36% of patients (n = 5), and there were a total of four fractures with migration in 21% of patients (n = 3). All fractures occurred in arms that had perforated the vena cava on early images. Two patients had already had their filters retrieved at 119 and 302 days, respectively; the remaining 12 patients elected to have their filters retrieved after evaluation. All 12 filters were retrieved at a mean of 1,021 days (range, 119-1,242 d +/- 134). Leg hook fractures occurred during eight of 12 filter retrieval procedures (67%). Recovery filter limb perforation of the vena cava increases over time and is associated with a 21% incidence of filter arm fracture and migration. Follow-up imaging is recommended. Filter retrieval has a high success rate and is the authors' preferred management strategy.

Complications Secondary to the Bard Retrievable Filter: A Case Report

Recent trials have demonstrated the efficacy of short-term insertion of inferior vena cava filters in the treatment and prophylaxis of venous thromboembolism certain populations, especially those with a reversible contraindication to anticoagulation. This has widened the use of retrievable filters in the hope of avoiding the long-term complications of permanent filters. However, no trials have demonstrated complications for each individual retrievable filter; and therefore, the decision for insertion of caval filter should be thoroughly studied and the benefit clearly determined. We discuss our experience with complications that we have encountered during retrieval of the Bard recovery filter in two patients.

Retrieval of the Recovery Filter after Arm Perforation, Fracture, and Migration to the Right Ventricle

The authors report a case of inferior vena cava filter arm perforation, followed by fracture and migration to the right ventricle causing chest pain and nonsustained ventricular tachycardia. Review of abdominal computed tomographic (CT) scans show the two filter arms that fractured and migrated had perforated the vena cava 2 years previously. Microscopic evaluation of the retrieved filter and limbs revealed bending metal fatigue at the fracture sites. This case and review of the literature suggest a causal relation between Bard Recovery filter arm perforation and subsequent fracture and migration. Percutaneous retrieval of filters with arm fracture or arm migration is recommended.

Retrievable Inferior Vena Cava Filters in High‐Risk Trauma and Surgical Patients: Factors Influencing Successful Removal

An Inferior vena cava filter (IVCF) provides prophylaxis against pulmonary embolism in patients that cannot be anticoagulated. A removable IVCF (R-IVCF) provides prophylaxis during a high-risk period while potentially eliminating long-term complications associated with a permanent IVCF. Factors influencing success of R-IVCF removal are ill-defined. The study was a retrospective review of a prospectively maintained patient registry comprising patients who received an R-IVCF (Bard Recovery and G2) at an academic level 1 trauma center. The influence of time in vivo, filter design, and filter head position on computed abdominal tomographic (CAT) scan (touching caval wall vs. free) on removal success was examined. Ninety-two patients each received an R-IVCF. Thirty-nine patients underwent removal attempt and 30 R-IVCFs were removed. Time in vivo did not affect removal success (success: 228 +/- 104 days versus unsuccessful: 289 +/- 158 days, p = 0.18). Filter design impacted filter head position (Recovery: 43% touching versus G2: 6% touching, p = 0.023). Position of the filter head influenced removal success (touching: 50% success versus free: 88% success, p = 0.021). Position of the filter head is the key determinant of removal success. Specific device designs may impact filter head position as was the case with the two designs in this analysis. Time in vivo does not affect removal success.

Form And Function Of Vena Cava Filters: How Do Optional Filters Measure Up?

The function of vena cava filters, preventing pulmonary embolism while maintaining caval patency, is associated with the design. Several characteristics have been reported. This report evaluates retrievable filter designs in comparison with previously marketed designs with respect to efficacy and safety. Three inferior vena cava (IVC) filters (Gunther Tulip, Bard Recovery, and the Cordis OptEase) were compared on the basis of design characteristics associated with function, shape, number of trapping levels, and fixation. Adverse events reported in the literature and to the US Food and Drug Administration Manufacturers and User Facility Device Experience Database (MAUDE) were summarized. The major differences among device types include the fixation, the volume and number of trapping levels, and the amount of metal in the IVC. The MAUDE registry reported adverse events that had been hypothesized from the analysis of in vitro and in vivo testing. The Recovery and OptEase filters had the highest number of clinically important reports. From 12 to 57% were retrieved between 3 days and 11 months. Adaptations made to facilitate retrieval led to unacceptable sequelae. The small number removed, the length of time they are left in place, and the risks associated with retrieval suggest that optional filters may not be equivalent to approved permanent devices.