scholarly journals The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism

2019 ◽  
Vol 2019 ◽  
pp. 1-15
Author(s):  
Michael D. Dake ◽  
Gary M. Ansel ◽  
Matthew S. Johnson ◽  
Robert Mendes ◽  
H. Bob Smouse

The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection against pulmonary embolism (PE) during transient high-risk periods and then to bioconvert after 60 days after implantation. At the time of bioconversion, the device’s nitinol arms retract from the filtering position into the caval wall. Subsequently, the stable stent-like nitinol frame is endothelialized. The Sentry bioconvertible IVC filter has been evaluated in a multicenter investigational-device-exemption pivotal trial (NCT01975090) of 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, and with contraindications to anticoagulation. Successful filter conversion was observed in 95.7% of patients at 6 months (110/115) and 96.4% at 12 months (106/110). Through 12 months, there were no cases of symptomatic PE. The rationale for development of the Sentry bioconvertible device includes the following considerations: (1) the period of highest risk of PE for the vast majority of patients occurs within the first 60 days after an index event, with most of the PEs occurring in the first 30 days; (2) the design of retrievable IVC filters to support their removal after a transitory high-PE-risk period has, in practice, been associated with insecure filter dynamics and time-dependent complications including tilting, fracture, embolization, migration, and IVC perforation; (3) most retrievable IVC filters are placed for temporary protection, but for a variety of reasons they are not removed in any more than half of implanted patients, and when removal is attempted, the procedure is not always successful even with advanced techniques; and (4) analysis of Medicare hospital data suggests that payment for the retrieval procedure does not routinely compensate for expense. The Sentry device is not intended for removal after bioconversion. In initial clinical use, complications have been limited. Long-term results for the Sentry bioconvertible IVC filter are anticipated soon.


2017 ◽  
Vol 22 (6) ◽  
pp. 512-517 ◽  
Author(s):  
Jieun Kang ◽  
Heung-Kyu Ko ◽  
Ji Hoon Shin ◽  
Gi-Young Ko ◽  
Kyung-Wook Jo ◽  
...  

Retrievable inferior vena cava (IVC) filters are increasingly used in patients with venous thromboembolism (VTE) who have contraindications to anticoagulant therapy. However, previous studies have shown that many retrievable filters are left permanently in patients. This study aimed to identify the common indications for IVC filter insertion, the filter retrieval rate, and the predictive factors for filter retrieval attempts. To this end, a retrospective cohort study was performed at a tertiary care center in South Korea between January 2010 and May 2016. Electronic medical charts were reviewed for patients with pulmonary embolism (PE) who underwent IVC filter insertion. A total of 439 cases were reviewed. The most common indication for filter insertion was a preoperative/procedural aim, followed by extensive iliofemoral deep vein thrombosis (DVT). Retrieval of the IVC filter was attempted in 44.9% of patients. The retrieval success rate was 93.9%. History of cerebral hemorrhage, malignancy, and admission to a nonsurgical department were the significant predictive factors of a lower retrieval attempt rate in multivariate analysis. With the increased use of IVC filters, more issues should be addressed before placing a filter and physicians should attempt to improve the filter retrieval rate.



Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 914-914
Author(s):  
Nikhil Bhalla ◽  
Anca Bulgaru ◽  
Lynn Church ◽  
Dinesh Kapur ◽  
Herb Lustberg ◽  
...  

Abstract Inferior vena cava (IVC) filters are used in patients (pts.) with Deep Venous Thrombosis (DVT) to prevent pulmonary embolism (PE) when anticoagulation cannot be administered. The purpose of this study was to analyze the use and outcomes of IVC filters in a community hospital. We reviewed the medical records of all pts. who had IVC filters implanted at William W. Backus Hospital between May 2003 and May 2005. Follow up information was obtained up to August 2005 by mailings from the attending physicians. 125 IVC filters were implanted in 121 pts., ages 18 to 93, with 61 males and 60 females. The indications for implantation were contraindication as follows: to anticoagulation in 72 pts. (58%), up coming surgical procedures in 33 pts. (26%), and severity of clot burden in 20 pts. (16%). 123 (98%) filters were deployed into an infrarenal position and 2 into a suprarenal position due to extensive clot in the IVC. Of the 105 filters that were not retrieved 60 were Gunther Tulip (GT) retrievable IVC filters, 42 were Cordis Trapease (CT) permanent IVC filters, 2 were stainless steel Greenfield IVC filters, and 1 was a Cordis Optease (CO) IVC filter. Of the 20 retrieved filters 19 were GT retrievable IVC filters and 1 was a CO IVC filter. Of the 125 filters, 74 were intended to be permanent filters (59%) and 51 (41%) were inserted with intention of retrieval. 31/51 (60%) were eventually not retrieved because of various reasons: need for additional surgery (12), poor pulmonary reserve (5), high-risk of bleeding (5), severity of clot burden (4), short life expectancy (4), and extremely high risk of recurrent DVT (1). Short-term and long-term anticoagulation was used in conjunction with the IVC filters in 21 and 81 pts. respectively. 38 (31%) of the 121 pts. experienced recurrent venous thromboembolism (VTE), 37 developed symptomatic DVT and 1 had a symptomatic PE. 3/20 (15%) of the pts. who had their filters retrieved developed recurrent DVT (18, 22, and 76 days after filter retrieval) compared with 34/105 (32%) pts. who had permanent filters. The only objectively documented symptomatic PE occurred in a pt. with a permanent filter. This pt. had a recurrent PE 7 months post GT IVC filter insertion diagnosed by chest CT scan with PE protocol. Complications were as follows: 1 pt. had transient hypertension immediately after IVC insertion and 1 pt. developed a transient low-grade fever after retrieval. 1 pt. developed retroperitoneal hematoma upon retrieval 75 days after implantation as documented by an IVC Gram and this pt. recovered without need for any intervention and there were no adverse clinical consequences. The implantation periods ranged from 2 to 104 days in the 20 retrieved filters with mean/median of 20/9 days. 4 of the 20 retrieved filters (20%) contained trapped emboli and none of these pts. subsequently developed PE. The GT retrievable IVC filter is now the filter of choice at our institution and can be implanted permanently or with retrieval in mind. Conclusion: Retrievable filters were removed up to 104 days post insertion in this series of pts. and the incidence of complications was negligible. Retrievable IVC filters may be substituted for permanent IVC filters to preserve the option of retrieval, and retrieval of filters beyond 3 months post implantation is feasible and should be studied further.



Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5912-5912
Author(s):  
Rena Shah ◽  
Anita Turk ◽  
Bilal Rahim ◽  
Waddah Arafat ◽  
Moniba Nazeef ◽  
...  

Abstract Inferior vena cava (IVC) filters, first introduced in 1998, have been utilized to reduce risk of pulmonary embolism (PE) in the setting of an inability to anticoagulate patients. The use of IVC filters has increased and continues to rise, especially with the introduction of retrievable IVC filters. Since their initial introduction, guidelines have been developed on the appropriate use of IVC filters. According to the American College of Chest Physicians (ACCP), the use of an IVC filter is limited to patients with an absolute contraindication to therapeutic anticoagulation or failure or complication of anticoagulation in the setting an acute proximal venous thrombus. Relative indications for IVC filter placement include high clot burden in setting of low cardiopulmonary reserve, high risk patients, or severe trauma without documented thrombosis. In 2010, the FDA announced a safety communication recommending removal of retrievable IVC filters due to reports of several adverse clinical outcomes associated with retained filters including thrombus formation, recurrent PE, filter migration, erosion or perforation through the IVC wall, and filter fracture with fragment embolization. In 2014, the FDA recommended removal of the IVC filter within 2 months after filter placement if the patient's risk of thrombosis had passed. In this retrospective analysis of IVC filter management, we reviewed indications for placement according to current guidelines as set by the ACCP, initiation of appropriate anticoagulation, complication rates, and retrieval rates. In addition, we compared the data prior to the FDA recommendations in late 2014 and data after the recommendations to determine if there was a change in practice. After reviewing 179 patients, 89 patients in 2014 and 90 patients in 2015, who underwent IVC filter placement, only 81% (N=145) of patients had appropriate indications for IVC filter placement and 30% (N=54) of patients had inappropriate anticoagulation after IVC filter placement, given as prophylactic dosing of low molecular weight heparin. A comparison of retrieval rates prior to and after the FDA warning, showed a 19% (60% in 2014 vs 79% in 2015) improvement in IVC filter removals. There was an 11% complication rate, mainly related to IVC filter related acute DVT or IVC occlusion. A root cause analysis specifically for inappropriate IVC filter placement and appropriate anticoagulation and determined that familiarity of the guidelines and non-evidence based recommendations from consultants were major factors. Based on the analysis, we next plan to utilize the electronic health record system to help clinicians understand indications and when to initiate appropriate anticoagulation, with the opportunity for hematology consultants to be involved in situations that do not clearly fit within published guidelines. Disclosures No relevant conflicts of interest to declare.



VASA ◽  
2020 ◽  
Vol 49 (6) ◽  
pp. 449-462 ◽  
Author(s):  
Xin Li ◽  
Ihab Haddadin ◽  
Gordon McLennan ◽  
Behzad Farivar ◽  
Daniel Staub ◽  
...  

Summary: Inferior vena cava (IVC) filter has been used to manage patients with pulmonary embolism and deep venous thrombosis. Its ease of use and the expansion of relative indications have led to a dramatic increase in IVC filter placement. However, IVC filters have been associated with a platitude of complications. Therefore, there exists a need to examine the current indications and identify the patient population at risk. In this paper, we comprehensively reviewed the current indications and techniques of IVC filter placement. Further, we examined the various complications associated with either permanent or retrievable IVC filters. Lastly, we examined the current data on filter retrieval.



Vascular ◽  
2004 ◽  
Vol 12 (4) ◽  
pp. 233-237 ◽  
Author(s):  
Russell C. Lam ◽  
Ruth L. Bush ◽  
Peter H. Lin ◽  
Alan B. Lumsden

Deep venous thrombosis with or without subsequent pulmonary embolism is a common preventable cause of hospital death. Although anticoagulation is the accepted standard therapy for thromboembolic disease, in situations in which anticoagulation is contraindicated, interruption of the inferior vena cava (IVC) by means of percutaneous placement of a filter has become a widely used alternative. We report our initial experience with two retrievable IVC filters. Between July 2002 and April 2003, 13 patients ( mean age 54 ± 7 years; range 29–75 years) underwent percutaneous placement of either the Gunther Tulip ( n = 5; Cook Inc., Bloomington, IN) or OptEase ( n = 8; Cordis, Miami Lakes, FL) IVC filter. Five patients had filters placed prophylactically before major surgery. The remaining eight patients had had a contraindication to anticoagulation, and three had experienced a hemorrhagic complication as a result of anticoagulation following either a recently documented deep venous thrombosis ( n = 3) or pulmonary embolism ( n = 5). Filters were successfully placed in all 13 patients, with a duration of implantation ranging from 2 to 15 days. Retrieval was attempted in 12 patients (in 1 patient, permanent filtration was secondarily requested) and was achieved in 10 (84.6%) patients. In 2 patients, retrieval failure was due to device angulation within the vena cava precluding safe retrieval. In both instances, the device used was the Gunther Tulip filter. No patient developed symptomatic pulmonary embolism or insertion-site thrombosis following either filter deployment or removal. Trapped thrombus in the filters was seen in all patients. Retrieval required a mean of 6.8 minutes (range 5–10.2 minutes) of fluoroscopy time. Neither filter migration nor caval injury was observed. Temporary IVC filters are effective and are associated with a high retrieval success rate. Further study is warranted to determine the maximal duration of implantation and whether retrievable IVC filters should expand the indications for IVC filter placement.



VASA ◽  
2011 ◽  
Vol 40 (2) ◽  
pp. 157-162 ◽  
Author(s):  
Piecuch ◽  
Wiewiora ◽  
Nowowiejska-Wiewiora ◽  
Szkodzinski ◽  
Polonski

The placement of an inferior vena cava (IVC) filter is a therapeutic method for selected patients with deep venous thrombosis and pulmonary embolism. However, insertion and placement of the filter may be associated with certain complications. For instance, retroperitoneal hematoma resulting from perforation of the wall by the filter is such a very rare but serious complication. We report the case of a 64-year-old woman with perforation of the IVC wall and consecutive hematoma caused by the filter who was treated surgically.



2021 ◽  
pp. 153857442110225
Author(s):  
Haidong Wang ◽  
Zhenhua Liu ◽  
Xiaofei Zhu ◽  
Jianlong Liu ◽  
Libo Man

Background: Inferior vena cava (IVC) filters are commonly used in China to prevent pulmonary embolisms in patients with deep vein thrombosis. However, IVC filter removal is complicated when the filter has penetrated the IVC wall and endovascular techniques usually fail. The purpose of this study was to evaluate the effectiveness and safety of retroperitoneal laparoscopic-assisted retrieval of wall-penetrating IVC filters after endovascular techniques have failed. Patients and Methods: We retrospectively evaluated a series of 8 patients who underwent retroperitoneal laparoscopic-assisted retrieval of a wall-penetrating IVC filter between December 2017 and November 2019. All patients had experienced at least 1 failure with endovascular retrieval before the study. The filters were slanted and the proximal retrieval hooks penetrated the posterior lateral IVC wall in all patients on computed tomography. Demographic information, operation parameters, and complications were recorded and analyzed. All patients were followed up for at least 12 months. Results: The procedure was successful in all patients. The median surgery time was 53.6 ± 12.7 min and the average blood loss was 45.0 ± 13.5 ml. No serious complication occurred during the patients’ hospitalization, which was an average of 6.4 days. The median follow-up time was 15.1 months, and no patient had deep vein thrombosis recurrence. Conclusions: Retroperitoneal laparoscopic-assisted retrieval is a feasible and effective technique, particularly when proximal retrieval hooks penetrate the posterior lateral wall of the IVC after endovascular techniques have failed. To some extent, the development of this technique at our institution has increased the success rate of filter removal and improved patient satisfaction.





Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1279-1279
Author(s):  
Parminder Singh ◽  
Robert G. Lerner ◽  
Tarun Chugh ◽  
Hoang Lai ◽  
Wilbert S Aronov

Abstract Introduction: Increasing use of inferior vena cava (IVC) filters in recent years as a preventative measure against pulmonary embolism (PE) has raised concern for usage outside of accepted guidelines. Based on the American College of Chest Physicians 2004 guidelines for the initial treatment of deep vein thrombosis (DVT) and PE, and the Eastern Association for the Surgery of Trauma 2002 guidelines for prophylaxis of PE, placement of an IVC filter is indicated in patients who either have, or are at high risk for thromboembolism, but have a contraindication for anticoagulation, a complication of anticoagulant treatment, or recurrent thromboembolism despite adequate anticoagulation. The purpose of our study is to identify patients who meet the guidelines for IVC filter placement and to compare clinical outcomes with those who did not meet the guidelines. Methods: Charts of 558 patients who received IVC filter placement were reviewed from Jan 1, 2004 to Dec 31, 2007. Patients were divided into two groups called within-guidelines or supplemental. The within-guidelines group included patients that met the criteria described above. The supplemental indication group included patients who did not have a contraindication or failure of anticoagulation. Patient characteristics and clinical outcomes between the two groups were compared and analyzed. Results: The within-guidelines group had 362 patients and the supplemental group had 196 patients. While there were more males in the within-guidelines group, age, race, length of stay, and in-hospital mortality were comparable between the two groups. Clinical follow-up in patients with a supplemental indication showed 1 (0.5%) case of post-filter PE, 2 (1%) cases of IVC thrombosis, 7 (3.6%) cases of DVT. Patients who were in the within-guidelines indication group had 4 (1.1%) cases of post-filter PE, 13 (3.6%) cases of IVC thrombosis, and 34 (9.4%) cases of DVT. All patients who developed post-filter PE had a prior DVT at the time of filter placement, and the risk of developing post-filter IVC thrombosis and PE is higher in patients with prior thromboembolic disease. Conversely, patients who did not have a VTE event before filter placement were at a significantly lower risk of developing IVC thrombosis and PE. Conclusion: Anticoagulation should be initiated at the earliest possible time in patients treated with an IVC filter to prevent subsequent venous thromboembolic disease. Our data does not support the use of IVC filter in patients who can tolerate anticoagulation and have no prior venous thromboembolic event due to the low risk of developing pulmonary embolism



2002 ◽  
Vol 16 (2) ◽  
pp. 193-196 ◽  
Author(s):  
E. Baylor Woodward ◽  
Alik Farber ◽  
Willis H. Wagner ◽  
David V. Cossman ◽  
J. Louis Cohen ◽  
...  


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