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 Inferior Vena Cava Filter Fracture and Migration to the Heart: A Review of the Literature and Case Report A thesis submitted to the University of Arizona, College of Medicine – Phoenix in partial fulfillment of the requirements for the Degree of Doctor of Medicine Brad Bowles Class of 2015 Mentor: Hani Shennib, MD Dedication I dedicate this project to my family, and thank them for their tremendous support and encouragement throughout my medical training. Acknowledgements I wish to thank my mentor Dr. Hani Shennib for his instrumental guidance and dedication to teaching. I also appreciate the support and input of Drs. Kelli Hickle, Burt Feuerstein and Matthew McEchron; without their help this thesis would not have been possible. Table of Contents Introduction .............................................................................................................................................. 1 Methods .................................................................................................................................................... 3 Results ....................................................................................................................................................... 4 Patient Demographics ........................................................................................................................... 4 Clinical Presentation ............................................................................................................................. 4 Imaging ................................................................................................................................................. 5 Filter Fracture and Migration ................................................................................................................ 5 Management ........................................................................................................................................ 7 Outcomes .............................................................................................................................................. 9 Data Tables .............................................................................................................................................. 10 Discussion................................................................................................................................................ 14 Clinical Presentation ........................................................................................................................... 16 Natural Progression ............................................................................................................................ 17 Initial Management ............................................................................................................................ 17 Prevention and Follow Up ................................................................................................................... 19 Proposed Management Algorithm ..................................................................................................... 20 Future Directions .................................................................................................................................... 21 Conclusions ............................................................................................................................................. 22 References .............................................................................................................................................. 23 Chapter 2: Migration of a fractured inferior vena cava filter strut to the right ventricle of the heart: a case report .................................................................................................................................................. 27 Abstract ................................................................................................................................................... 28 List of Figures and Tables ........................................................................................................................ 29 Background ............................................................................................................................................. 30 Case Presentation ................................................................................................................................... 31 Discussion................................................................................................................................................ 39 Conclusions ............................................................................................................................................. 40 Chapter 1: A systematic review of the literature on IVC filter fracture and migration to the heart Abstract Background and Significance: The utilization of IVC filters for pulmonary embolism prevention has increased significantly over the past decade as the indications continue to expand. Although the risks associated with IVC filters are small, a well‐known complication is filter fracture and subsequent embolization of the fragment. Case reports have been published on the devastating effects of fragment migration to the heart, causing intense chest pain, pericardial effusion, cardiac tamponade and death. Research Question: There is a paucity of experience and guidelines for treating patients with a metallic foreign object lodged within the heart. Is there a consensus on the proper management of these cases? How do these patients present and what are the outcomes of treatment? Some clinicians have chosen to observe and monitor, while others have gone to the operating room for open‐heart surgery and retrieval of the fragment. Methods: In an attempt to answer these questions, a systematic review of the published literature was conducted between 1985 and 2015. Only articles related to IVC filter fracture and subsequent fragment migration to the heart were included. The clinical presentation, workup, management, treatment and outcomes were collected as available. Results: A total of 23 articles were published consisting of a prospective study, retrospective series and case reports. There were 37 migrated fragment to the heart reported in 29 patients. The most common clinical presentations were chest pain (69.0%) and no symptoms (27.6%). Regarding treatment, ten patients underwent observation, three had successful endovascular retrieval, 12 went to the operating room for open‐heart surgery and four cases were unreported. Of the 12 patients with reported pericardial effusion, 11 (91.7%) underwent open surgical repair. Of the eight asymptomatic patients, seven (87.5%) were ultimately in observation and the management of the other was unreported. Conclusions: There appears to be a consensus in the literature that observation and close follow up are appropriate options for asymptomatic patients. Symptomatic patients with pericardial effusion may benefit from open‐heart surgery. Cardiovascular compromise such as cardiac tamponade should be managed with open surgery. Based upon these findings and other details in the cases, we have proposed a management algorithm. List of Figures and Tables Figure 1: The locations of 37 IVC filter fragments within the heart. Figure 2: The different management options chosen for the 29 cases presenting with IVC filter fracture and migration to the heart. Figure 3: An increasing trend in the number of articles published on IVC filter fracture and migration to the heart. Figure 4: A proposed management algorithm for patients presenting with IVC filter fracture and migration to the heart. Table 1: Clinical data for the 29 published studies on IVC filter fracture and migration to the heart. The type of study, patient demographics and clinical presentation are reported for each patient. Table 2: Continued clinical data. The reported cardiovascular status of each patient is shown. Table 3: Continued clinical data. Specifics relating to the characteristics of the filters and fractures are shown, including the reported location and indwelling time. Table 4: Continued clinical data. Specifics relating to the management and follow up of each patient are reported. Introduction Pulmonary embolism (PE) is the third most common cause of cardiovascular disease‐
related death after acute ischemic syndromes and stroke, accounting for 300,000 deaths annually (1). Deep vein thrombosis (DVT) is by far the most common nidus for the disease process. First‐line treatment is anticoagulation therapy for patients who are at high‐risk for developing deep vein thrombosis. Although anticoagulation is effective in preventing future PE, it is associated with significant risks, the most concerning of which is an increased risk of bleeding. Anticoagulation medications are contraindicated in certain patient populations and the alternative treatment is mechanical filtration. As a DVT becomes dislodged from the lower extremity, it passes through the inferior vena cava (IVC) as it migrates towards the heart and eventually wedges within the pulmonary vasculature. IVC filters are metallic devices deployed within the vessel to capture these clots and allow the body to break them down before they can cause a PE. The utilization of IVC (inferior vena cava) filters for pulmonary embolism prevention has been increasing worldwide (2‐5). Some controversy exists on the appropriate indications for their use particularly in light of uncommon, but significant complications. Well‐known complications of IVC filters include IVC thrombosis, perforation, fracture and migration. Some of the most catastrophic complications involve migration of the whole filter or fragments to the heart. Whole filter migration is commonly associated with rapid cardiovascular compromise requiring emergent open‐heart exploration and removal. However, a paucity of studies has been published regarding the clinical presentation or management of IVC filter fracture and migration to the heart. 1 The incidence of filter fracture has been reported between 1.0 and 40.0%, mostly associated with increased indwelling time, the interval between filter placement and patient presentation with fractures. (6‐9). The filter with the most publications related to fracture is the Bard Recovery (CR Bard; Tempe, AZ) with U.S. FDA (Food and Drug Administration) approval in 2002. Embolization of filter fractures has been estimated at less than 1% (10). This review was designed to assemble and discuss physician experience with these challenges cases and propose new guidelines for management. 2 Methods Medline, Embase and Web of Science databases were searched for all English‐language reports of IVC filter fragments to the heart from 1985 to 2015. The bibliography of each identified article was also searched for relevant publications. All case reports, series and previous reviews were included in this systematic review. No randomized control trials were identified. Reports of whole filter migration to the heart were excluded. Publications with fractured struts that did not migrate or migrated to locations other than the heart, including the pulmonary vasculature, were not included. We have included a case report from our own experience that meets the inclusion criteria (11)(See Chapter 2). 3 Results A review of the literature yielded 23 publications between 2006 and 2015 on IVC filter fracture and strut migration to the heart with a total of 29 patients. Sixteen publications were case reports. Six publications consisted of single‐center, retrospective studies with four reporting on a particular IVC filter manufacturer. One publication was a prospective study at a single institution (12). All articles were reviewed in their entirety and the age, gender, signs, symptoms, device, indwelling time, location, imaging modalities, treatment and outcomes were collected. Many reports, particularly the retrospective studies, did not include all of these data. Published reports included 13 Bard Recovery filters (CR Bard; Tempe, AZ), five Bard G2 filters (CR Bard), one ALN filter (ALN International; Miami, FL), one Bard Denali filter (CR Bard), one Bard G2X filter (CR Bard), one Bard Meridian filter (CR Bard), one Greenfield filter (Medi‐
Tech/Boston Scientific; Watertown, MA), one Gunther‐Tulip filter (William Cook Europe; Bjaeverskov, Denmark), and five filters were not identified, although three were described as retrievable. Patient Demographics Of the 29 patients, eight were male, 13 were female, and the gender was not disclosed in eight patients. The mean patient age was 52 and the median was 54, with a range of 23 to 83. The age of three patients was not reported. A total of five patients (17.2%) were less than 35 years of age. Four patients (13.8%) were reported to be obese and in four patients (13.8%), significant physical exertion or increased intra‐abdominal pressure was associated with the onset of symptoms. Clinical Presentation Overall, the symptoms or lack thereof at time of presentation were reported in 100% of patients. The most common symptom was chest pain in 20 of the 29 total patients (69.0%). Eight of the remaining nine patients were asymptomatic, and the final patient only reported abdominal pain. Those who reported chest pain or no symptoms accounted for 96.6% of patients. In addition to chest pain, six patients (20.1%) complained of dyspnea, two of shoulder pain (6.9%) and two of nausea (6.9%). Two patients had witnessed syncopal episodes (6.9%). 4 Seven patients (24.1%) were found to have an arrhythmia, six (20.1%) were hypotensive, five (17.2%) had lead abnormalities on electrocardiogram (ECG), and eight (27.6%) presented with signs of cardiac tamponade. Imaging Computed tomography (CT) was the most common imaging modality used in 17 of the 21 cases (81.0%) that reported imaging utilization. Nine patients (31.0%) had an echocardiogram reported as part of the workup. Pericardial effusion was noted in 12 patients (41.4%). Other reported imaging modalities included fluoroscopy and plain films. Filter Fracture and Migration A total of 37 filter struts fractured and migrated to the heart in 29 patients. Twenty‐
three patients (79.3%) had a single strut fracture. Two patients (6.9%) were reported to have a total of three fragments in the heart and four patients (13.8%) had two fragments in the heart. The average number of fractures per patient regardless of fragment location was 1.8, with a range of 1 to 4. Of the 37 fragments that embolized to the heart, 16 (43.2%) were found in the free wall of the right ventricle. Four fragments (10.8%) were found entirely in the pericardium, with four additional struts protruding into the pericardium from the right ventricle for a total of eight (21.6%). Three struts (8.1%) were found in the interventricular septum and one (2.7%) was in the inferior wall of the left ventricle. The exact location within the heart was not specified in 13 fragments (35.1%)(Figure 1). 5 Fragment Locations
18
16 14
12
10 8
6
Number of Fragments
4
2 0
Figure 1: The locations of 37 IVC filter fragments within the heart. *Four fragments were completely within the pericardium and an additional four were situated both in the right ventricular free wall and the pericardium; for a total of eight fragments with at least a portion within the pericardium. 6 Average filter indwelling time, the interval between filter placement and presentation, was 43.0 months, with a range of 4 to 120 months. Five cases did not mention an indwell time. Management Of the 29 cases, 25 (86.2%) reported on their management method which was classified into three categories: observation (10 patients), successful endovascular retrieval (3 patients) and open surgery (12 patients)(Figure 2). 7 Management Options
14
12
10
8
Cases
6
4
2
0
Open surgery
Observation
Endovascular
Unknown
Figure 2: The different management options chosen for the 29 cases presenting with IVC filter fracture and migration to the heart. 8 Three patients were initially taken for endovascular retrieval without success. One patient was subsequently taken to the OR for open retrieval because of subsequent cardiac tamponade. The other two patients were asymptomatic and observed thereafter. The seven patients with reported evidence of cardiac tamponade all underwent open surgical repair. Of the 12 patients with reported pericardial effusion, 11 (91.7%) underwent open surgical repair. Of the eight asymptomatic patients, seven (87.5%) were ultimately in observation and the management of the other was unreported. All fragments in the heart were identified prior to intervention except in one patient (13) where it was discovered during pericardial hematoma evacuation intraoperatively. The filter body was reportedly retrieved in 12 patients, remained in six patients and the remainder are unknown. Outcomes It was reported that ten patients (34.5%) returned for uneventful follow up and resolution of symptoms: five (50.0%) after observation, one (10.0%) after endovascular retrieval, and four (40.0%) after open retrieval. The only two reported complications (6.9%) were after open repairs and included sternotomy wound dehiscence and a patient with possible acute pulmonary embolism on post‐
operative day four. One of the 29 patients died (3.4%); reported as “sudden death”. It is unknown if this was related to the filter fracture and migration to the heart or another cause. 9 Data Tables Case No. Type Author Year Age Gender Obesity Physical exertion Chest pain Dyspnea Syncope Asymptomatic Other Symptoms 1 Prospective Kuo et al 2013 58 M ‐ ‐ yes ‐ ‐ no ‐ 2 Retrospective Nicholson et al 2010 26 ‐ ‐ ‐ yes yes ‐ no ‐ 3 Retrospective Nicholson et al 2010 27 ‐ ‐ ‐ no no no yes none 4 Retrospective An et al 2014 45 M ‐ ‐ no no no yes none 5 Retrospective Tam et al 2012 49 M ‐ ‐ no no no yes none 6 Retrospective Nicholson et al 2010 54 ‐ ‐ ‐ yes yes ‐ no ‐ 7 Retrospective Nicholson et al 2010 63 ‐ ‐ ‐ yes ‐ ‐ no ‐ 8 Retrospective An et al 2014 74 F ‐ ‐ no no no yes none 9 Retrospective Nicholson et al 2010 78 ‐ ‐ ‐ yes yes ‐ no palpitations 10 Retrospective An et al 2014 83 F ‐ ‐ no no no yes none 11 Retrospective Dinglasan et al 2012 ‐ ‐ ‐ ‐ no no no yes none 12 Retrospective Carroll et al 2012 ‐ ‐ ‐ ‐ yes ‐ ‐ no ‐ 13 Retrospective Vijay et al 2012 ‐ ‐ ‐ ‐ no no no yes none 14 Case Report Shennib et al 2014 23 F yes yes yes no no no none 15 Case Report Kassi et al 2014 26 F ‐ ‐ yes ‐ ‐ no 16 Case Report Kalavakunta et al 2009 31 F ‐ yes yes ‐ no no ‐ nausea, diaphoresis 17 Case Report Poudel et al 2015 38 M ‐ ‐ no no no yes none 18 Case Report Kumar et al 2008 40 F ‐ yes yes no no no 19 Case Report Kuo et al 2015 46 F yes ‐ yes no no no 20 Case Report Desjardins et al 2010 47 M ‐ ‐ yes yes ‐ no none shoulder pain shoulder pain 21 Case Report Chandra et al 2008 53 M yes ‐ yes yes ‐ no ‐ 22 Case Report Khurana et al 2015 53 M ‐ ‐ yes ‐ ‐ no ‐ 23 Case Report Rogers et al 2009 56 F ‐ ‐ yes ‐ yes no ‐ 24 Case Report Thakur et al 2015 58 F ‐ ‐ yes yes ‐ no ‐ 25 Case Report Hull et al 2008 62 F yes ‐ yes ‐ ‐ no palpitations 26 Case Report 2014 62 F ‐ ‐ yes ‐ ‐ no ‐ 27 Case Report Baik et al Yarmohammadi et al 2015 64 M ‐ ‐ yes ‐ ‐ no ‐ 28 Case Report Saeed et al 2006 66 F ‐ yes yes no yes no 29 Case Report Pontone et al 2012 74 F ‐ ‐ no ‐ ‐ no nausea abdominal pain Table 1: Clinical data for the 29 published studies on IVC filter fracture and migration to the heart. The type of study, patient demographics and clinical presentation are reported for each patient. (‘‐‘ = not reported) 10 Case No. Hypotension Arrythmia
Effusion
Cardiac Tamponade 1 yes ‐
yes
‐ 2 ‐ NSVT
‐
‐ 3 ‐ ‐
‐
‐ 4 ‐ no
‐
‐ 5 ‐ ‐
‐
‐ 6 ‐ ‐
yes
yes 7 ‐ NSVT
‐
‐ 8 ‐ no
‐
‐ 9 ‐ PVCs, couplets
‐
‐ 10 ‐ no
‐
‐ 11 ‐ ‐
‐
‐ 12 ‐ ‐
‐
‐ 13 ‐ ‐
‐
‐ 14 no no
yes
no 15 ‐ ‐
‐
‐ 16 yes no
yes
yes 17 ‐ ‐
‐
‐ 18 no no
no
no 19 ‐ ‐
yes
yes 20 ‐ ‐
yes
no 21 yes tachycardia, RBBB
yes
yes 22 yes tachycardia
yes
yes 23 yes bradycardia
yes
yes 24 ‐ ‐
‐
‐ 25 ‐ NSVT
‐
‐ 26 ‐ ‐
yes
‐ 27 ‐ ‐
yes
‐ 28 yes no
Yes
Yes 29 ‐ ‐
‐
‐ PVC = Premature ventricular contractions, RBBB = right bundle branch block, NSVT = nonsustained ventricular tachycardia, '‐' = not reported Table 2: Continued clinical data. The reported cardiovascular status of each patient is shown. 11 Case # of No. fxs 1 2 Bard G2X 24
RV, retroperitoneum
2 3 Bard Recovery 52
2 heart, 1 lung
3 3 Bard Recovery 51
2 heart, 1 lung
4 1 Bard G2 24
RV
5 1 ‐ 52
RV
6 3 Bard Recovery 37
3 heart
7 1 Bard Recovery 44
1 heart
8 1 Bard G2 35
pericardium 9 3 Bard Recovery 56
2 heart, 1 lung
10 1 Bard G2 41
RV
11 1 Bard Recovery ‐
RV
12 2 ‐ ‐
interventricular septum, peripheral vein 13 4 Bard Recovery ‐
3 heart, R lung
14 4 Bard Recovery 96
RV/pericardium, L lung, R lung, duodenum 15 1 (retrievable) 36
interventricular septum
16 1 Bard Recovery 48
pericardium
17 1 Bard G2 60
RV
18 1 Bard Recovery 8
RV
19 2 Bard Denali 6
RV
20 2 Bard Recovery 36
left ventricle
21 1 Greenfield 22 1 Bard G2 65
RV/pericardium
23 1 Gunther‐Tulip 72
pericardium
24 2 (retrievable) ‐
RV, IVC wall
25 2 Bard Recovery 24
RV, IVC wall
26 2 (retrievable) 36
RV/pericardium, L lung
27 1 Bard Meridian 6
RV/pericardium
28 1 Bard Recovery 4
RV
29 4 ALN Filter Type Indwelling Time (mo) ‐
120
Locations RV
interventricular septum, pericardium, R lung, liver
Table 3: Continued clinical data. Specifics relating to the characteristics of the filters and fractures are shown, including the reported location and indwelling time. (‘‐‘ = not reported) 12 Case No. Treatment Follow Up
Complications
Filter Body Retrieved 1 open yes
no
yes
2 ‐ ‐
‐
‐
3 ‐ ‐
‐
‐
4 observation ‐
no
no
5 observation yes
no
no
6 open ‐
‐
‐
7 ‐ ‐
‐
‐
8 observation yes
no
no
9 ‐ ‐
‐
‐
10 observation yes
no
no
11 observation yes
no
yes
12 endovascular ‐
no
‐
13 observation ‐
no
yes
14 open yes
no
yes
15 endovascular ‐
no
yes
16 open ‐
no
‐
17 observation ‐
no
yes
18 open yes
no
yes
sternal wound 19 open yes dehiscence yes 20 open ‐
no
yes
21 open ‐
no
‐
22 open ‐
no
‐
23 open ‐
no
‐
24 observation ‐
‐
no
25 endovascular yes
no
yes
26 observation ‐
no
yes
27 open ‐
‐
‐
28 open ‐
possible PE
yes
29 observation yes
no
no
Table 4: Continued clinical data. Specifics relating to the management and follow up of each patient. (‘‐‘ = not reported) 13 Discussion The placement of IVC filters is significantly increasing worldwide (2‐5). Despite FDA recommendations that retrievable filters be removed once the risk of pulmonary embolism has resolved, often this does not correlate in practice (14). Gaspard et al reported that retrievable filters are rarely removed. They reported that only 3.7% of retrievable filters were successful removed in 298 patients at their institution (15). In turn, we can predict that published cases similar to those in this review will continue to rise with increased prevalence and indwelling times as seen over the last decade. The number of articles has nearly doubled (increase of 87.5%) in the last five years compared to the previous five (Figure 3). 14 Reports in the Literature
6
5
4
3
Number of Articles
2
1
0
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
Figure 3: An increasing trend in the number of articles published on IVC filter fracture and migration to the heart. The first article ever published was in 2006, nearly a decade ago. 15 In addition, there are considerably more cases of IVC filter fracture and migration to the heart that are not currently reported in the literature. For example, a Manufacturer and User Device Experience (MAUDE) database search performed by Desjardins et al revealed 64 cases of IVC filter fragment migration into the heart between January 2003 and December 2009 for the Bard Recovery filter alone (16). Another MAUDE database search by Andreoli et al revealed 154 “limb embolizations” irrespective of filter manufacturer type between January 2009 and December 2012 (17). Clinical Presentation In patients with a history of filter placement, physicians should have a high suspicion for migration and/or fracture when patients presents with acute onset of chest pain, particularly in a younger patient without risk factors for acute coronary syndrome or pulmonary embolism. Chest pain in the single most common symptom reported in the literature. Moreover, patients with pericardial effusion should be evaluated for IVC filter integrity. From our literature review, other associated signs may include pericarditis and the sequelae of cardiac tamponade. Nicholson et al also highlighted a similar constellation of symptoms with pulmonary embolism which may be confused with fracture migration (18). To further complicate these cases, some patients may not remember or be aware they have an IVC filter. Our own patient had a filter placed while in a coma after a traumatic motor vehicle collision and was surprised by her diagnosis (11)(see Chapter 2). The preferred imaging modality is CT, which provides superior visualization of the metallic struts. Kassi et al suggest that three‐dimension CT reconstruction of the heart may help assess any involvement with the coronary arteries prior to percutaneous retrieval (19). 16 Natural Progression After evaluating in detail all the publications included in this review, the cases suggest a predictable progression of filter fracture and migration. First, a more common complication is IVC perforation by one or more limbs of the filter secondary to excessive outward forces. From this position, multiple stressors have been hypothesized that contribute to metal fatigue of the limb near the apex of the filter: IVC flattening from the physiologic respiratory cycle, strenuous physical exertion, blood flow vibrations and arterial pulsation (20). Kuo et al have identified fractures consistent with high‐cycle bending metal fatigue on more than one occasion (12, 21). Over time, and with constant venous return, these fractured limbs can migrate into the lumen of the IVC and travel superiorly. From the heart, a fractured limb may pass through the pulmonic valve and wedge in the pulmonary vasculature or become lodged in the right ventricular wall. Aided by cardiac contractions, the fragment can then migrate through the myocardium causing perforation and varying degrees of hemopericardium. Patients may complain of chest pain, dyspnea and referred shoulder pain as the fragment abrades the diaphragm and passes into the subcutaneous tissue anteriorly. Initial Management The management of fractured struts in the heart appears to be controversial. Some authors suggest surgical retrieval is the only option (18, 22) while others would choose percutaneous methods or observation as long as the patient is stable. These differences may be related to advances in endovascular techniques or the comfort and level of training at specific institutions. Most of the studies reported open surgery approaches to filter fragment removal, which seemed appropriate given that 91.7% of these patients had pericardial effusion. The risks and benefits of open surgery must be evaluated on an individual basis. Progressive symptoms and cardiovascular compromise should be indications for open exploration because of current limitations in percutaneous approaches. Endovascular retrieval or observation may subject these patients to worsening effusion and possible cardiac tamponade. Although one article 17 reported endovascular retrieval in the setting of pericardial effusion, it appears that the effusion was present a month prior on CT scans at an outside hospital. From our own evaluation, the CT images at the time of retrieval show no evidence of effusion and the authors did not mention any effusion at that time. Open‐heart surgery appears to be a definitive approach to fragment removal, cardiac defect repair and evacuation of any pericardial collection. A trend away from open procedures has significantly improved endovascular techniques although endovascular retrieval remains challenging. A controlled catheter approach is difficult given the contracting ventricle and elevated blood velocities. In addition, there are significant associated risks such as damaging the tricuspid valve or cordae tendinae, ventricular wall perforation and arrhythmias caused by wire irritation. One author reported having a code cart, defibrillator and transvenous pacemaker available, and cardiac surgery team on standby during the retrieval (20). In the past, most sharp foreign objects in the heart have required open surgery, however, improvement in capture devices and techniques have reduced this need (Hull). In three cases, an endovascular approach failed because the fragments were embedded within the myocardium and snaring proved futile (21,23‐24). Some authors report that by reviewing available imaging, particularly CT, the operator should be able to assess whether the fragment location is amenable to endovascular retrieval or not. An extraluminal position, significant incorporation into adjacent structures or walls, involvement of the aorta or other large vessels and the presence of pericardial effusion should discourage endovascular retrieval and an open procedure should be entertained if retrieval is deemed necessary (23). Regardless, it can be assumed that more of these cases will be treated with minimally invasive, catheter‐based approaches in the future because of improved morbidity and mortality. Despite the risks associated with an IVC filter fragment in the heart, observation may be a viable option. The literature suggests that asymptomatic patients can be observed without immediate complications or required interventions. In fact, a larger number of patients with IVC filter fragments in the heart may not be identified at this time but remain clinically silent. 18 Prevention and Follow Up The most obvious ways to prevent IVC filter fracture and migration to heart are to remove the device once the risk for pulmonary embolism has resolved or to monitor filters at regular intervals. Filter indwelling time has been shown to be directly correlated with fractures (25). Also, the incidence of fragment migration to heart should be significantly less in double apex filter designs which would require two fractures for the formation of a free fragment. Patients in observation must be followed closely because they are at particular risk for further migration, ventricular perforation and tamponade. At least two articles have suggested that an echocardiogram is beneficial for follow up of fragments that were not removed (13,26). Any change in position or accumulation of fluid in the pericardial space can be monitored appropriately. Abdominal x‐rays have been used to evaluate IVC filters for fractures or missing limbs and may prove to be a beneficial screening tool at regular intervals for filter integrity. Missing limbs may be identified in the heart with chest x‐ray, although CT is the preferred modality. It has been suggested that an association exists between strenuous physical activity or increased abdominal pressure (e.g. retching) and filter fracture and migration (22,27‐28). Such practices should be discouraged prior to retrieval in patients with IVC filter fragments that have the potential to embolize to the heart. Again, patients may not be aware of their filter or the risks associated with it. This proves to be difficult when arranging for filter retrieval. Appropriate follow up should be encouraged. 19 Proposed Management Algorithm Figure 4: A proposed management algorithm for patients presenting with IVC filter fracture and migration to the heart. The most significant clinical finding suggesting observation as the management of choice is an asymptomatic patient. Patients found to have pericardial effusion will most likely require open‐heart surgery at the time of this study. 20 Future Directions The literature would benefit from larger prospective studies correlating clinical presentation, management and outcomes. Currently, a registry has been formed to address IVC filter safety, named PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters). It is a multidisciplinary initiative conceived and created by the Society of Interventional Radiology and the Society for Vascular Surgery in association with the FDA and industry. The study will be composed of approximately 2,500 patients who will undergo IVCF placement in up to 50 centers in the United States (29). In addition, individual clinicians should be encouraged to report their own experience with fragment migration to the heart. 21 Conclusions With the expanded use of IVC filters, cardiovascular surgeons and interventionalists should be aware of the clinical presentation and management of IVC filter fracture and migration to the heart. There appears to be a consensus in the literature that observation and close follow up are appropriate options for asymptomatic patients. In addition, symptomatic patients with pericardial effusion may benefit from open‐heart surgery. Cardiovascular compromise such as cardiac tamponade should be managed with open surgery. We encourage the continued publication of these challenging cases; more experience and data are still needed. 22 References 1. Heit JA, Cohen AT, Anderson FA. VTE Impact Assessment Group. Estimated annual number of incident and recurrent, non‐fatal and fatal venous thromboembolism (VTE) events in the U. S. Blood 2005;106:267 2. Friedell M, Nelson P, Cheatham M. Vena Cava Filter Practices of a Regional Vascular Surgery Society. Annals of Vascular Surgery 2012; 26: 630‐635. 3. Hammond C, Bakshi D, Currie R, et al. Audit of the use of IVC filters in the UK: experience from three centres over 12 years. Clinical Radiology 2009; 64:502‐10. 4. Kuy S, Dua A, Lee CJ, Patel B, Desai S, Dua A, Szabo A, Patel PJ: National trends in utilization of IVC filters over a decade in the United States. J Vasc Surg. 2013 May;57(5):73S‐74S. 5. Moore P, Andrews J, Craven T, et al. Trends in vena caval interruption. Journal of Vascular Surgery 2010; 52:118‐26. 6. Babuty D QL, Charbonnier B, et al. Partial interruption of the inferior vena cava using a percutaneous endovenous filter. Archives of Mal Coeur Vaiss 1990; 83: 1389‐1396. 7. Ferris EJ, McCowan TC, et al. Percutaneous inferior vena caval filters: follow‐up of seven designs in 320 patients. Radiology 1993; 188: 851‐856. 8. Tam MD, Spain J, Lieber M, Geisinger M, Sands MJ, 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 Feb;23(2):199‐
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Journal of Vascular and Interventional Radiology 2012; 23: 181‐187. 24. Poudel D, Pathak R, et al. Stuck in the Heart: Embolized Strut Fracture of IVC Filter. Vascular and Endovascular Surgery 2015; 49(3‐4): 93‐94. 25. Durack JC, Westphalen AC, et al. Perforation of the IVC: rule rather than exception after longer indwelling times. Cardiovascular and Interventional Radiology 2012 Apr;35(2):299‐308. 26. Pontone F, Andreini D, et al. Asymptomatic struts fracture and multiple embolization as a late complication of ALN removable vena cava filter implantation. European Heart Journal 2013 Aug;34(30):2353. 27. Kalavakunta JK, Thomas CS, Gupta V. A needle through the heart: rare complication of inferior vena caval filters. J Invasive Cardiol. 2009 Nov;21(11):E221‐3. 28. Saeed I, Garcia M, McNicholas K. Right ventricular migration of a recovery IVC filter's fractured wire with subsequent pericardial tamponade. Cardiovasc Intervent Radiol. 2006 Jul‐Aug;29(4):685‐6. 29. Joint press release from Society for Vascular Surgery (SVS) and Society of Interventional Radiology (SIR) on behalf of the IVC Filter Study Group Foundation: Seven filter manufacturers set to participate in multicenter Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) study, as two societies collaborate to improve patient care. Available at: http://www.sirweb.org/news/newsPDF/Release_PRESERVE_final111214.pdf. Accessed November 24, 2015. 25 30. An T, Moon E, Bullen J, et al. Prevalence and Clinical Consequences of Fracture and Fragment Migration of the Bard G2 Filter: Imaging and Clinical Follow‐up in 684 Implantations. Journal of Vascular and Interventional Radiology 2014; 25: 941‐948. 31. Baik P, Fourzali R, Salsamendi J, Salerno T. Transventricular migration of an inferior vena cava filter limb. Ann Thorac Surg. 2014 Jan;97(1):343. 32. Carroll M, Ahanchi S, Kim J, Panneton J. Endovascular foreign body retrieval. Journal of Vascular Surgery 2013; 57: 459‐63. 33. Khurana D, Raza J, et al. Fractured Inferior Vena Cava Filter Strut. Texas Heart Institute Journal 2015; 42(2): 181‐3. 34. Rogers NA, Nguyen L, Minniefield NE, Jessen ME, de Lemos JA. Fracture and embolization of an inferior vena cava filter strut leading to cardiac tamponade. Circulation. 2009 May 12;119(18):2535‐6. 35. Thakur K, Dhawan N, et al. Wire in the Heart: Fracture and Fragment Embolization of Retrievable Inferior Vena Cava Filter into the Right Ventricle. Case Reports in Cardiology 2015. Article ID 938184. 36. Vijay K, Hughes J, Burdette A, et al. Fractured Bard Recovery, G2, and G2 Express Inferior Vena Cava Filters: Incidence, Clinical Consequences, and Outcomes of Removal Attempts. Journal of Vascular and Interventional Radiology 2012; 23: 188‐194. 37. Yarmohammadi H, Bekwelem W, et al. Hemopericardium from inferior cava filter strut fracture and embolization. Journal of Cardiovascular Computed Tomography 2015 Jul 10. pii: S1934‐5925(15)00220‐8. 26 Chapter 2: Migration of a fractured inferior vena cava filter strut to the right ventricle of the heart: a case report 27 Abstract A 23 year old woman presented with sudden onset retrosternal chest pain following an attempt to move a heavy object from her vehicle. Multiple fractured struts of an inferior vena cava filter were identified in the distal right and left pulmonary artery branches, and in the free wall of the right ventricle. A small pericardial effusion was noted. Because of the depth of penetration into the right ventricle, it was perceived not to be amenable to endovascular retrieval. Over several days of observation, she continued to have progressive retrosternal and left shoulder pain. She underwent exploratory sternotomy and extraction of a strut that was partially protruding from the right ventricle and abrading the diaphragmatic pericardium. The patient recovered quite well and was discharged on the third postoperative day. 28 List of Figures and Tables Figure 1: An image of a complete, unsheathed Bard Recovery inferior vena cava filter. Figure 2: Fractured strut embedded in the right ventricular free wall, protruding into the diaphragm. Figure 3: Fractured strut migration near duodenal sweep. Figure 4: Fractured strut retrieved from right ventricular free wall is shown. 29 Background Migration of fragments is a known complication of inferior vena cava (IVC) filter placement. Fragments that migrate to the right side of the heart can further lodge in the right ventricular wall or may migrate further into the pulmonary arteries. Right ventricular wall implantation can progress to penetration, hemopericardium, tamponade and possible death. Management of an IVC fragment which migrates into the right ventricle can be challenging. There are neither clear guidelines nor sufficient literature of how to best manage and treat such complex situations. We present a case of IVC filter fracture and migration into the right ventricle which was treated with sternotomy and extraction of the fragment from its free wall. 30 Case Presentation Our patient is a 23 year old Caucasian female who presented to the emergency department complaining of severe, sharp mid‐chest pain that increased with inspiration. The patient stated that the pain started while she was lifting a stroller and stooping to prepare a vehicle seat for her four month old child. On presentation, she was in obvious distress and complaining of chest pain. She denied shortness of breath or any other symptoms. She denied any prior symptoms. On examination, she was found to be tachycardic, her blood pressure was normal and review of all other systems was negative. Her electrocardiogram showed sinus rhythm and was within normal limits. The first troponin was elevated at 0.40 and the second was 0.29. All other labs were within normal limits. CT angiography revealed no evidence of pulmonary embolism; however, four tiny metal objects consistent with fractured struts from an IVC filter were identified in the heart, left and right pulmonary arteries, and upper abdomen. Records obtained from another hospital revealed that a Bard Recovery IVC filter (Bard Peripheral Vascular, Tempe, Arizona) was placed in the course of treating a life‐threatening multiple trauma from a motor vehicle accident eight years previously (see Figure 1). The patient apparently was in coma for a month and was unaware of the existence of the IVC filter. 31 Figure 1: An image of a complete, unsheathed Bard Recovery inferior vena cava filter. 32 The first strut was protruding inferiorly through the free wall of the right ventricle and was associated with a small pericardial effusion (Figure 2). Two were found in the subsegmental branches of the pulmonary arteries of the left and right lungs. The fourth fragment was found outside the inferior vena cava along the duodenal sweep adjacent to the anterior‐inferior margin of the uncinate process (Figure 3). A limb of the remaining structure of the IVC filter was observed to be penetrating into the adjacent abdominal aortic wall superior to the iliac bifurcation. 33 Figure 2: Fractured strut embedded in the right ventricular free wall, protruding into the diaphragm. 34 Figure 3: Fractured strut migration near duodenal sweep. The IVC filter body can be seen within the lumen of the IVC. Multiple remaining limbs are shown including one that appears to penetrate the IVC and protrude posteriorly toward the spine. Another limb appears to be attached to the apex of the filter but is displaced superiorly. 35 Initial treatment was limited to in‐hospital observation with pain management. However, the pain progressed and became intolerable with excruciating left shoulder pain over the ensuing 48 hours. A repeat CT revealed further penetration of the right ventricular strut through the ventricular wall and into the diaphragm with increasing pericardial effusion. Consequently, the patient was taken to the operating room where midline sternotomy and pericardiotomy was performed. Approximately 300 cc of blood was drained from the pericardial space. An intact, 2.5 cm metal strut was found protruding from the free wall of the right ventricle and was removed (Figure 4). The small laceration was repaired with a pledgeted 4‐0 proline horizontal mattress suture. No cardiopulmonary bypass was needed. 36 Figure 4: Fractured strut retrieved from right ventricular free wall is shown measuring almost 2.5 cm. 37 The patient tolerated the procedure well and had immediate relief of her preoperative pain. She had an uneventful recovery and was discharged 3 days postoperatively. At a 3 month follow up appointment, the patient was doing well and had no symptoms. The patient subsequently had successful endovascular removal of the main fractured IVC filter. 38 Discussion There appears to be an expanding use of IVC filters for prevention of pulmonary embolism worldwide [1]. Although IVC filters have been shown to be relatively safe and effective, significant complications have been reported. Fracture and migration is a recognized complication of IVC filter placement, however, patients may not be aware that a filter can fracture and migrate as in the presented case. Activities involving a sudden, intense increase in intra‐abdominal pressure have been noted to be frequently associated with filter fracture and migration. Chest pain is the most common presentation. Migration of the complete filter or a fractured segment to the heart or lungs may also manifest with new acute shock and hemodynamic instability. CT scans of the chest appear to be the most suited radiologic modality for identifying migrated fragments of an IVC filter within the chest. Correlation between chest pain and the location of migrated struts can assist in making management decisions. Increasing chest and shoulder pain with progression of pericardial effusion warrants intervention. Radiologic evaluation of the location and depth of penetration of the strut within the right ventricle may assist in determining if an endovascular or open surgical approach is more appropriate. Our patient presented with chest pain that was initially controlled pharmacologically. She was hemodynamically stable; however, we observed increasing chest pain and progression of the pericardial effusion, which justified intervention. A less‐invasive, endovascular retrieval would have been preferred, but the fractured strut appeared to be advancing further into the ventricular free wall and diaphragm, making the retrieval more technically challenging. Because our patient was young and otherwise in good health, open surgery was chosen as a definitive method for the strut retrieval, cardiac defect repair and effusion drainage. 39 Conclusions There is a paucity of studies addressing the optimal management of patients with migrating struts from fractured IVC filters. A review of the literature revealed only eight case reports [2,3,4,5,6,7,8,9] clearly documenting IVC filter fragment migration to the right ventricle. A variety of treatment options ranging from conservative pain management to endovascular or open surgical extraction of the migrating struts have been suggested. However, no clear recommendations have been proposed as to the optimal modality. Cardiovascular surgeons need to be aware of the increasing prevalence of IVC filters and the risk of fracture and migration to the right ventricle. Further studies and guidelines are needed to appropriately manage this complication. 40 Consent Informed consent was obtained from the patient for publication of this Case report and 41 References 1. Kuy S, Dua A, Lee CJ, Patel B, Desai S, Dua A, Szabo A, Patel PJ: National trends in utilization of IVC filters over a decade in the United States. J Vasc Surg. 2013 May;57(5):73S‐74S. 2. Baik P, Fourzali R, Salsamendi J, Salerno T. Transventricular migration of an inferior vena cava filter limb. Ann Thorac Surg. 2014 Jan;97(1):343. 3. Chandra PA, Nwokolo C, Chuprun D, Chandra AB. Cardiac tamponade caused by fracture and migration of inferior vena cava filter. South Med J. 2008 Nov;101(11):1163‐4. 4. Hull JE, Han J, Giessel GM. Retrieval of the recovery filter after arm perforation, fracture, and migration to the right ventricle. 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