Abstract: Objectives. Percutaneous procedures through femoral access in patients with inferior vena cava (IVC) filter may be at risk of complications. We evaluated the feasibility and safety of left atrial appendage (LAA) closure through femoral access in patients previously implanted with IVC filter. Methods. From November 2011 to March 2018, a total of 5 patients with history of IVC filter implantation were referred to our center for percutaneous LAA closure, representing 3.6% of the 137 procedures performed during the study period. The IVC filter devices were placed from 2 to 26 months before the index procedure. Results. LAA closure was successfully implanted in all cases using an Amulet device in 3 patients and a Watchman device in 2 patients. A femoral approach was performed in all patients using 12 or 14 Fr sheaths. Before crossing IVC filters, venographies did not detect any thrombus. All steps of IVC filter crossing were performed under fluoroscopic guidance. No immediate or late complications related to the procedure occurred after 10.1 ± 3.9 months of follow-up. Conclusion. LAA closure in patients with previously implanted IVC filter is safe as long as careful x-ray monitoring is observed.
J INVASIVE CARDIOL 2019;31(5):128-132.
Key words: inferior vena cava filter, left atrial appendage closure
The number of percutaneous cardiac interventions for structural heart diseases is increasing, and these interventions concern a growing population. Among these procedures, left atrial appendage (LAA) closure is recommended by the European guidelines in patients with non-valvular atrial fibrillation (AF) at high risk of thromboembolism and contraindicated for long-term oral anticoagulation (OAC). In the setting of OAC contraindication, the implantation of inferior vena cava (IVC) filter is recommended in patients who experienced venous thromboembolism (VTE) event. Thus, patients eligible for LAA closure may also have a previously implanted IVC filter. However, LAA closure requires venous transfemoral approach to access the left atrium, which is usually considered to be contraindicated in IVC filter cases due to the risks of guidewire entrapment and filter dislodgment.1-9 Simultaneously, several reports10-23 have shown the feasibility and safety of crossing an IVC filter using large sheaths up to 21 Fr,11 allowing various interventional procedures in the right atrium, on the atrial septum, or requiring transseptal puncture.
Herein, we described a case series of 5 patients who underwent percutaneous LAA closure across a previously implanted IVC filter.
Study population. From November 2011 to March 2018, a total of 5 AF patients with a previously implanted IVC filter and a contraindication for long-term OAC were referred for LAA closure, representing 3.6% of the 137 procedures performed during this period at Henri Mondor Hospital in Creteil, France. Informed consent was obtained from each participant or the participant’s legally authorized representative. The study protocol, which adhered to the principles of the Declaration of Helsinki, was approved by the institutional review board of our hospital.
LAA closure procedure. Preprocedural imaging included both transesophageal echocardiography (TEE) and cardiac computed tomography angiography (CCTA) in all patients. These two exams were performed to exclude LAA thrombus, to assess the suitability of LAA closure, and especially to determine the type and size of the device. The device size was confirmed during the procedure using TEE measurements after reaching a left atrial pressure over 10 mm Hg.
All procedures were performed under general anesthesia with TEE monitoring for accurate device positioning and safety. A right femoral venous access was achieved in all patients using 12 Fr introducers. Before crossing the IVC filter, a venography was performed with iodixanol (Visipaque; GE Healthcare) for detection of filter or IVC thrombosis (Figures 1 and 2), and the IVC filter position was stored on fluoroscopy for detection of device migration. A .035˝ stiff J-tipped guidewire (St. Jude Medical) was advanced into the superior vena cava (SVC) under fluoroscopic guidance across the IVC filter, avoiding the center of the filter (Figures 1 and 2). A 63 cm, 8.5 Fr, long-sheath, Swartz SL0 braided transseptal guiding introducer (St. Jude Medical) and dilator were inserted through the IVC filter into the SVC over the guidewire (Figure 1). Then, a posteroinferior transseptal puncture was performed using a 71 cm BRK transseptal needle (St. Jude Medical) and a .035˝ guidewire was positioned into the left upper pulmonary vein. According to the device’s size, a dedicated delivery sheath was positioned in front of the LAA ostium. Then, a 5 Fr marked pigtail was advanced into the LAA in order to safely position the delivery sheath deeper into the LAA. We, then, positioned the appropriately sized device at the LAA landing zone for the Amplatzer Amulet device (Abbott) and until the corresponding radiopaque marker band for Watchman device (Boston Scientific). Before device release, we strove to achieve the recommended “position, anchor, size, and seal” (PASS) criteria for the Watchman device and the five signs of correct deployment for the Amulet device: (1) tire-shaped lobe; (2) separation of the lobe from the disc; (3) concavity of the disc; (4) axis of the lobe perpendicular to the neck axis at landing zone; and (5) width of the lobe ≥2/3 within the circumflex artery. After the procedure, patients were admitted for 24-48 hours and had a transthoracic echocardiography evaluation the following day.
Follow-up. Clinical follow-up was performed at 3, 6, and 12 months, and an imaging control using CCTA and/or TEE was performed at 3 months. The occurrence of major adverse cardiac event (MACE), including stroke, device-related thrombosis, and cardiovascular death, was noted for each patient throughout the follow-up.
Statistical analysis. Descriptive statistics were used to describe the baseline patient characteristics. Continuous variables were summarized as mean ± standard deviation, or median and interquartile range if needed. Categorical variables were summarized as frequency and percentage.
Study population. Characteristics of the 5 patients are described in Table 1. All patients were in AF, with high thromboembolic (mean CHA2DS2VASc score, 5.4 ± 1.2) and hemorrhagic risk (mean HAS-BLED score, 4.0 ± 0). Contraindication to OAC was mainly related to intracranial bleeding. Indication for IVC filter implantation was the occurrence of a recent VTE event, mainly in patients with a persistent risk of VTE. The delay between the IVC filter implantation and the LAA closure procedure ranged from 2 months to >2 years.
LAA closure procedure. Before IVC filter crossing, no thrombosis was observed during venography. All manipulations across the IVC filter were monitored using fluoroscopy, and the stability of the IVC filter was confirmed after catheter removal. LAA closure was successful in all patients (Figures 1 and 2) and no instances of catheter entrapment or filter dislodgment were observed (Figure 3). The implanted devices are listed in Table 1. An Amulet device was implanted in patients #1, #2, and #3 using a 12 Fr Amplatzer TorqVue 45° x 45° delivery sheath (St. Jude Medical). A Watchman device was implanted in patients #4 and #5 using a 14 Fr Watchman double-curve delivery sheath.
Early and mid-term follow-up. After a mean follow-up of 10.1 ± 3.9 months, no early or late complications related to the procedure were observed in these 5 patients.
Several reports have shown the feasibility and safety of transcatheter interventions with large sheaths through a previously implanted IVC filter.10,11,13-22 However, this is the first case series including patients requiring LAA closure.
AF patients indicated for LAA closure have a high thromboembolic risk associated with a contraindication to long-term OAC. In the same way, IVC filter implantation is required in patients with a VTE event in case of OAC contraindication. In addition, it was previously demonstrated that VTE and thromboembolism related to AF have common risk factors.24,25 Thus, there is an overlap of patient characteristics in these two populations. Therefore, performing LAA closure using the femoral approach in patients with a previously implanted IVC filter is not uncommon. However, the access through an IVC filter can carry some risks. Cases of guidewire entrapment and filter dislodgment1-9 as well as the theoretical risk of pulmonary embolism related to clot embolism from the IVC filter have been reported.
Guidewire entrapment by some old IVC filters can occur, particularly with J-tipped guidewires, and it is conceivable that some filters are more likely to entrap catheters or to be dislodged than others. Two in vitro studies reported by Kaufman et al4 and Stavropoulos et al9 evaluated respectively the six and eight commercially available IVC filters in the United States and four standard guidewire shapes (15 mm, 3 mm, and 1.5 mm J-tipped, and straight) in an artificial vein. The aim of these studies was to compare the risk of engaging and entrapping guidewires in the IVC filters. They found that the TrapEase, the 12 Fr stainless-steel Greenfield device, and the VenaTech LGM device4,9 could entrap guidewires with a J-tip 3 mm or less. Later, Wu et al27 described 38 cases of filter/wire entrapment and reviewed the strategies to prevent iatrogenic IVC filter entrapment and dislodgment during blind insertion of central venous catheters. They found that iatrogenic IVC filter displacement occurred immediately after filter placement, during wire exchange for central venous catheter placement using the same right internal jugular venous access. All of these cases involved J-tipped guidewires. However, our series of LAA closures using Amulet and Watchman devices was performed via a transfemoral approach in patients with previously implanted ALN (ALN Implants Chirurgicaux) and VenaTech LP (B. Braun) IVC filter devices using J-tipped guidewires. All procedures were successfully performed without IVC filter-related complications despite repeated crossing through the IVC filter by J-tipped guidewires, the transseptal puncture systems, and the dedicated delivery sheaths. Of note, LAA closure was performed at least 2 months after IVC filter implantation, which is the time limit for device endothelialization.10,26 Therefore, we think that this procedure is safe as long as careful manipulation of guidewires and sheaths under x-ray guidance is observed.
In case of wire entrapment, its early identification and the use of an appropriate technique under fluoroscopic guidance are associated with a high success rate of disengagement, avoiding filter dislodgment. Wu et al recommended an initial attempt to straighten the J-tip wire by pinching and stretching the wire and advancing it to disengage from the filter. If there is inadequate length of protruding segment to safely load catheters, the monorail technique and snare/forceps technique can be considered. In this study, all iatrogenic filter migrations occurred after vigorous tugging of the wire against resistance. Martinez et al18 described one case of simultaneous LAA and patent foramen ovale closure. In this report, the key step was to secure the access by positioning a long (90 cm) 10 Fr sheath above the IVC filter, avoiding further manipulation through the IVC filter by removing it only at the end of the procedure. A careful x-ray guided retrieval of the trans-IVC filter sheath was performed. The procedures were successful, with no damage related to the IVC filter. Although the femoral venous approach for LAA closure is the mainstay, several alternatives could be discussed, especially in cases of IVC filter thrombosis or obstruction. Transjugular, upper-extremity, and transhepatic venous approaches were previously reported in patent foramen ovale closure procedures.31-37 However, these techniques are more difficult than the usual femoral access, given that the equipment used was designed primarily for manipulation from the lower extremities (especially for the transseptal puncture). The transseptal catheters are too long and the curves of the transseptal needle are not shaped for access from the neck. 22,23,26-37 Then, the authors35 opted for unfurling the deflectable sheath to apply pressure to the interatrial septum. In this case report, the use of three-dimensional TEE was of great importance to ensure optimal equipment orientation, to safely obtain left atrial access, and to guide catheter orientation and direction to visualize the dimensions and orientation of the LAA. Furthermore, the proximity to the x-ray tube in upper-extremity based percutaneous procedures increases radiation exposure for the operators. In addition, the location of physicians and the equipment (ie, fluoroscopy arm) should be redesigned to ensure the feasibility and sterility of the procedure. Thus, these approaches should only be considered in cases of congenital interruption or IVC thrombosis.
Study limitations. The small number of patients in our case series is its main limitation, but few data are available in the literature related to LAA closure. Only two types of IVC filter were used in this case series and all were free of thrombus formation, allowing IVC filter crossing in all cases.
This case series confirms the safety and efficacy of LAA closure across a previously implanted IVC filter. A careful approach under fluoroscopic guidance should be used to avoid complications.
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*Joint first authors.
From the Cardiology Unit, University Henri Mondor Hospital, Creteil, France.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Lellouche reports consulting fees from St. Jude Medical and Boston Scientific. The remaining authors report no conflicts of interest regarding the content herein.
Manuscript submitted November 28, 2018 and accepted December 18, 2018.
Address for correspondence: Nicolas Lellouche, MD, PhD, Service de Cardiologie Hôpital Henri Mondor, 51 Avenue du Marechal de Lattre de Tassigny, 94000 Creteil, France. Email: firstname.lastname@example.org