Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3771_Библиотеки_им_академика_М_И_Перельмана.pdf
230 Tyler Callese, et al.
65. Righini M, Galanaud JP, Guenneguez H, Brisot D, Diard A, Faisse P, etal. Anticoagulant therapy
for symptomatic calf deep vein thrombosis (CACTUS): A randomised, double-blind, placebocontrolled trial. Lancet Haematology. 2016 Dec 1;3(12):e556–62.
66. Kim KA, Choi SY, Kim R. Endovascular treatment for lower extremity deep vein thrombosis: An
overview. Korean Journal of Radiology. 2021 Jun;22(6):931–43.
67. Ageno W, Haas S, Weitz JI, Goldhaber SZ, Turpie AGG, Goto S, etal. Characteristics and management of patients with venous thromboembolism: The Garfield-VTE registry. Thrombosis and
Haemostasis. 2019 Feb;119(2):319–27.
68. Elman EE, Kahn SR. The post-thrombotic syndrome after upper extremity deep venous thrombosis in adults: Asystematic review. Thrombosis Research. 2006;117(6):609–14.
69. Bosch FTM, Nisio MD, Büller HR, van Es N. Diagnostic and therapeutic management of upper
extremity deep vein thrombosis. Journal of Clinical Medicine. 2020 Jul;9(7):2069.
70. Moore R, Lum YW. Venous thoracic outlet syndrome. Vascular Medicine. 2015 Apr
1;20(2):182–89.
71. Hangge P, Rotellini-Coltvet L, Deipolyi AR, Albadawi H, Oklu R. Paget-Schroetter syndrome:
Treatment of venous thrombosis and outcomes. Cardiovascular Diagnosis and Therapy. 2017
Dec;7(Suppl 3):S285–90.
72. Taylor JM, Telford RJ, Kinsella DC, Watkinson AF, Thompson JF. Long-term clinical and functional outcome following treatment for Paget – Schroetter syndrome. British Journal of Surgery.
2013 Oct 1;100(11):1459–64.
73. Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, etal. Antithrombotic therapy for VTE disease. Chest. 2016 Feb;149(2):315–52.
74. AbuRahma AF, Sadler D, Stuart P, Khan MZ, Boland JP. Conventional versus thrombolytic
therapy in spontaneous (effort) axillary-subclavian vein thrombosis. The American Journal of
Surgery. 1991 Apr 1;161(4):459–65.
75. Vik A, Holme PA, Singh K, Dorenberg E, Nordhus KC, Kumar S, etal. Catheter-directed thrombolysis for treatment of deep venous thrombosis in the upper extremities. CardioVascular and
Interventional Radiology. 2009 Sep 1;32(5):980–87.
76. Kim HS, Patra A, Paxton BE, Khan J, Streiff MB. Catheter-directed thrombolysis with percutaneous rheolytic thrombectomy versus thrombolysis alone in upper and lower extremity deep
vein thrombosis. CardioVascular and Interventional Radiology. 2006;29(6):1003–7.
77. Koury JP, Burke CT. Endovascular management of acute upper extremity deep venous thrombosis and the use of superior vena cava filters. Seminars in Interventional Radiology. 2011
Mar;28(1):3–9.
78. Fuller T, Neville E, Shapiro J, Muck AE, Broering M, Kulwicki A, etal. Comparison of aspiration thrombectomy to other endovascular therapies for proximal upper extremity deep
venous thrombosis. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2022 Mar
1;10(2):300–5.
79. Teter K, Arko F, Muck P, Lamparello PJ, Khaja MS, Huasen B, etal. Aspiration thrombectomy
for the management of acute deep venous thrombosis in the setting of venous thoracic outlet
syndrome. Vascular. 2020 Apr;28(2):183–88.
80. Rachapalli V, Boucher LM. Superior Vena Cava Syndrome: Role of the Interventionalist. Canadian Association of Radiologists Journal. 2014 May1;65(2):168–76.
81. Sfyroeras GS, Antonopoulos CN, Mantas G, Moulakakis KG, Kakisis JD, Brountzos E, etal.
Areview of open and endovascular treatment of superior vena cava syndrome of benign aetiology. European Journal of Vascular and Endovascular Surgery. 2017 Feb;53(2):238–54.
82. Cui J, Kawai T, Irani Z. Catheter-directed thrombolysis in acute superior vena cava syndrome
caused by central venous catheters. Seminars in Dialysis. 2015;28(5):548–51.
83. Ghanavati R, Amiri A, Ansarinejad N, Hajsadeghi S, Riahi Beni H, Sezavar SH. Successful treatment of a catheter-induced superior vena cava syndrome through catheter-directed thrombolysis: Acase report. Journal of Tehran University Heart Center. 2017 Oct;12(4):188–91.
84. Kee ST, Kinoshita L, Razavi MK, Nyman UR, Semba CP, Dake MD. Superior vena cava syndrome: Treatment with catheter-directed thrombolysis and endovascular stent placement.
Radiology [Internet]. 1998 Jan 1 [cited 2023 Feb 26]; Retrieved from https://pubs.rsna.org/
doi/10.1148/radiology.206.1.9423671
Section4
Special Topics
Chapter 22
Indications,Techniques, and Retrieval
of Inferior Vena Cava Filters
Charles A. Banks and Marc A. Passman
INTRODUCTION
In the United States, the annual incidence of deep venous thrombosis (DVT) with pulmonary thromboembolism (PTE) is approximately 900,000 cases according to the Center for
Disease Control and Prevention (CDC). Mortality ranges from 6–10% in patients presenting with DVT/PTE with an estimated 25% of patients with PTE experiencing sudden
death as initial symptom.
with PTE, prompt initiation of therapeutic anticoagulation has remained the standard of
treatment in patients presenting with DVT. Additionally, chemoprophylaxis with prophylactic-dose anticoagulation has been used in patients at high-risk for developing DVT such
as polytrauma patients, orthopedic patients requiring prolonged immobility, and major
surgical patients.
A minority of patients with contraindications to therapeutic or prophylactic anticoagulation require alternative means of therapy. Inferior vena cava filters (IVCF) were initially
introduced in 1969 as a mechanical modality for prevention of PTE.2 After initial market
approval, annual utilization of IVCFs increased rapidly with peak in the early 2000s and
gradual downtrend after 2010.
deployed annually as a therapeutic or prophylactic measure in patients unable to be therapeutically anticoagulated.
societies have established evidence-based guidelines for IVCF utilization. In this chapter, we
provide an overview of current indications, deployment, and retrieval of IVCFs.
1
Due to the relatively high morbidity and mortality associated
3,4
In recent years, an estimated 65,000–94,000 IVCFs are
3,5
Utilizing the available data in the literature, multiple academic
CLINICAL INDICATIONS
Practice patterns regarding IVCF utilization have varied widely based upon institutional
utilization, geographical location, and patient population.
demic societies have developed guidelines concerning appropriate use of IVCFs.
6–8
Multiple sub-specialty aca-
2,9
The primary consensus among these specialties is to reserve IVCF placement for thromboembolic
protection in patients presenting with DVT or PTE who have absolute contraindications
to therapeutic anticoagulation or have experienced a complication or recurrent DVT/PTE
despite therapeutic anticoagulation.
2,10
Therapeutic anticoagulation is absolutely contraindicated in patients with severe coagulopathy or thrombocytopenia, active hemorrhage,
recent hemorrhagic stroke, high risk intracranial lesions, or poorly controlled hypertension
(SBP > 230).
2,10,11
Therapeutic anticoagulation may also be contraindicated in patients with
significant hepatic or renal dysfunction due to inability to adequately metabolize anticoagulants. Lastly, patients with severely compromised pulmonary capacity secondary to PTE are
considered primary candidates for IVCF placement due to increased mortality with potential
recurrent PTE.
DOI: 10.1201/9781003316626-26 233
2,10
234 Charles A. Banks and Marc A. Passman
There are few prospective randomized controlled trials (RCTs) validating the efficacy of IVCF
deployment. Guidelines and practice paradigms are largely derived from reported clinical experience and retrospective cohort studies evaluating the efficacy of IVCF placement in different
patient populations.
10
The initial development of IVCF guidelines were primarily based upon
the early RCT known as the PREPIC trial (Prevention du Risqué d’Embolie par Interruption
12,13
Cave).
This trial randomized patients experiencing acute DVT to anticoagulation alone
and anticoagulation combined with IVCF. This trial successfully demonstrated the efficacy of
IVCF placement in preventing PTE with 4.8% of no-IVCF patients compared to 1.1% of IVCF
patients experiencing PTE at 12 days and 20.8% compared to 11.6% experienced recurrent
DVT at 2years, respectively.
12
This pattern was demonstrated in a subsequent study evaluating
the same patient cohort at 8-years follow-up revealing long-term PTE protection. However, the
study demonstrated an increased risk of DVT and no survival benefit in the IVCF group.
13
To
date, the PREPIC trials remain the largest RCT conducted regarding IVCF utilization. However,
it is difficult to generalize the findings from the PREPIC trial because the clinical decision
regarding IVCF utilization is primarily in patients without the ability to be anticoagulated.
Multiple, small RCTs have corroborated the original findings of the PREPIC trial.
11,14–17
These studies primarily focused on specific patient groups such as cancer patients, trauma
patients, and patients with prior PTE. Ameta-analysis of these RCTs including 1,274 patients
revealed an overall decrease in the incidence of PTE in patients receiving IVCF placement
without a significant increase in recurrent DVTs (11.9% vs 9.1%; p = 0.58). Conglomerate
results from the RCTs failed to demonstrate a statistically significant overall mortality difference between the IVCF group and anticoagulation alone group at 3 months (9.22% vs
6.73%, respectively; p = 0.13). Overall, no current study has demonstrated a survival benefit
related to IVCF placement when therapeutic anticoagulation alone is feasible.
11,18
As endovascular techniques evolved and IVCF technology expanded to retrievable IVCFs
(rIVCF), practice paradigms incorporated extended or relative indications for IVCF placement including prophylactic deployment. The development of rIVCFs in the early 2000s
resulted in an exponential increase (3-fold) in rIVCF deployment as prophylactic thromboembolic protection specifically in polytrauma patients.
4,19,20
However, an associated increase
in adverse events and relatively low attempted removal rate (<50%) prompted an issuance
from the FDA in 2010 that intensified scrutiny and reduced excessive utilization of rIVCF
over subsequent years.
for improved post-market approval surveillance and filter retrieval.
19
An additional FDA warning was issued in 2014 regarding the need
21
Although results have been mixed, studies focusing on prophylactic IVCF placement have
demonstrated some efficacy of IVCF placement in certain selective scenarios.
17,18,22
In a large
propensity-matched study investigating effects of prophylactic IVCF placement in patients with
high bleeding risk, Muriel and colleagues demonstrated a trend toward lower overall mortality in the IVCF group (6.6% vs 10.2%; p = 0.12) as well as a significantly lower PTE-related
mortality in the IVCF group compared to no-IVCF (1.7% vs 4.9%; p = 0.03).
22
As a patient
population at relatively high risk for DVT and subsequent PTE, prophylactic IVCF placement
has been well studied in trauma patients.
23
In the multicenter RCT conducted by Ho and colleagues, prophylactic IVCF placement failed to provide significant benefit in terms of PTE
prevention or death when compared to pharmaco-prophylaxis alone.17 However, in a subset
of patients primarily with head or spinal cord injuries precluding prophylactic anticoagulation,
prophylactic IVCF placement was associated with 0% incidence of PTEs compared to 14.7%
in the no-IVCF group. Ameta-analysis of multiple observational studies conducted in 2011
revealed significant reduction in PTE events in trauma patients undergoing prophylactic IVCF
placement compared to prophylactic anticoagulation alone.
to provide conclusive evidence regarding the survival benefit provided by IVCF placement.
23
This meta-analysis was unable
23
Acute DVT with or
without PTE
Therapeutic anticoagulation
without routine IVCF
placement
Recurrent DVT/PTE despite
therapeutic anticoagulation
Extensive workup for
anticoagulation failure prior
to IVCF
Indications, Techniques, and Retrieval of Inferior Vena Cava Filters 235
High risk DVT/PTE:
Polytra um a, major
surgery, prolonged
immobilization
Contraindication to therapeutic or
prophylactic anticoagulation**
Recommend against
routine IVCF placement as
DVT/PTE prophylaxis
Consideration for
IVCF placement
Recommend prophylactic
anticoagulation dosing
Consider preoperative
imaging via CT, IVUS, or
venogram to rule out
anatomical anomalies
Determine appropriate IVCF type
based upon specic circumstances
IVCF placement using standardized technique.
Consider bedside options for critically ill.
Enroll patient into IVCF
surveillance program
Evaluate for IVCF removal as soon as
anticoagulation feasible within 3-months
Figure 22.1 Algorithm based on evidence-based recommendations regarding the use of inferior vena cava
(IVC) filters in the treatment of patients with or at substantial risk of venous thromboembolic disease.
* IVCF = Inferior vena cava filter; DVT = Deep venous thrombosis; PTE = Pulmonary thromboembolism;
IVUS = intravascular ultrasound. ** Therapeutic anticoagulation is absolutely contraindicated in patients
with severe coagulopathy or thrombocytopenia, active hemorrhage, recent hemorrhagic stroke, high risk
of intracranial lesions, or poorly controlled hypertension [SBP > 230]. Therapeutic anticoagulation may also
be contraindicated in patients with significant hepatic or renal dysfunction due to inability to adequately
metabolize anticoagulants.
236 Charles A. Banks and Marc A. Passman
Recently, the PRESERVE trial (Predicting the Safety and Effectiveness of Inferior Vena
Cava Filters) was completed.
24
This study was a large, nonrandomized trial consisting of
1429 patients with contraindications to anticoagulation undergoing IVCF placement (71.7%
with current DVT/PTE and 8.9% prophylactic). Despite the lack of randomization in this
study, the authors demonstrated the efficacy and safety of IVCF utilization with a 2.2%
significant adverse event rate and 98.3% freedom from clinically significant PTE. In patients
with prophylactic indication for IVCF placement, no patients experienced PTE, 3.9% experienced DVTs, and 0.7% experienced caval thrombosis. Of the cohort, 44.5% underwent IVCF
retrieval with median time from implantation to retrieval of 86 days. Adverse events related
to IVCF retrieval procedures occurred in 1.95% of patients.
24
The quality of evidence from all studies have been evaluated and combined to generate
evidence-based guidelines for the utilization of IVCFs.
2
The current guidelines established by
the Society of Interventional Radiology in collaboration with multiple other academic societies including the Society for Vascular Surgery are represented as an algorithm in Figure22.1.
IVC FILTER DEVICES
The most critical design feature of an IVCF is to minimize embolic events while maximizing
IVC patency and prevent IVC occlusion. Many different IVCF designs are available and are
utilized in a variety of patient scenarios. Different materials have been employed in manufacturing of IVCFs including nitinol, stainless steel, titanium, and cobalt. Although makeup and
size differ between filter types, most IVCFs preserve the traditional conical shape as utilized
in the initial Greenfield IVCF.
ing excellent thromboembolic protection.
25
The conical design preserves IVC patency while provid-
25
The conical filter can maintain nearly 50% of
IVC luminal patency despite being filled to 70% capacity. The excellent success of the early
Greenfield IVCF models provided a framework for the evolution of IVCF technology and
deployment strategies.
Overall, IVCFs are divided into two primary categories, permanent and retrievable.
Permanent IVCFs (pIVCFs) are intended as lifelong mechanical thromboembolic protection modality in at risk patients and are designed without a percutaneous retrieval method.
Retrievable or optional IVCFs (rIVCFs) are designed with features allowing for endovascular
removal should the need for mechanical thromboembolic protection resolve. The utilization
of rIVCFs allows for temporary thromboembolic prophylaxis and provides a delay in determining permanent requirement for thromboembolic protection. All rIVCFs are also FDA
approved for permanent deployment providing enhanced flexibility compared to permanent
19
filters.
Currently available FDA approved IVCFs are listed and imaged in Table22.1.
Few studies have been conducted comparing the outcomes of pIVCFs and rIVCFs. Aretrospective study consisting of 702 patients receiving IVCF (60.8% rIVCF and 39.2% pIVCF)
demonstrated similar rates of DVT and symptomatic IVC thrombosis at 1year. Currently,
no randomized controlled trial has been performed appraising the outcomes of pIVCFs and
rIVCFs. However, in a large evaluation of the MAUDE (Manufacturer and User Facility
Device Experience) registry, Andreoli and colleagues revealed significantly higher frequency
of all adverse events in patients receiving rIVCF.
27
These adverse events included device fracture, migration, IVC thrombus, and limb embolization. Studies have indicated that risk of
adverse events related to rIVCFs are directly related to dwell time.
19,25–28
Additionally, prolonged dwell time of greater than 7-months is associated with a high failure rate of conventional retrieval techniques at 40.9%.
28
Other studies focusing on specific rIVCF designs have
Table 22.1 Currently Available Inferior Vena Cava Filters and Device Information
Delivery Maximum Maximum FDA-
Device Manufacturer Material Design Approach (Fr) Diameter Length Use
Sheath Caval Deployed Approved
Greenfield Boston Scientific A. Stainless steel
Filter Natick, MA Single Jugular
Bird’s Nest Cook Inc. Stainless Steel Variable Femoral or 12 40 80 Permanent
Filter Bloomington, Jugular
IN
Simon Nitinol Bard Peripheral Nitinol Conical Femoral or 7 28 38 Permanent
Filter Vascular Tempe , Bilevel Jugular
AZ
B. Titanium
C. Low profile
Stainless steel
Conical; Femoral or 12 28 49 Permanent
Trapping
Indications, Techniques, and Retrieval of Inferior Vena Cava Filters 237
(Continued)
Table 22.1 Currently Available Inferior Vena Cava Filters and Device Information (Continued)
Maximum Maximum FDA-
Delivery Caval Deployed Approved
Device Manufacturer Material Design Approach sheath (Fr) Diameter Length Use
Denali Bard Peripheral Nitinol Conical Femoral or 8.4 28 43 Permanent
Vascular Tempe, Bilevel Jugular
AZ
VenaTech LP Braun/Vena Tech, Cobalt Conical Femoral or 7 28 43 Permanent
Filter Bethlehem, PA Chromium Single Jugular
Trapping
VenaTech Braun/Vena Tech, Cobalt Conical Femoral or 12.9 28 -- Convertible
Convertible Bethlehem, PA Chromium Single Jugular
Trapping
238 Charles A. Banks and Marc A. Passman
Option Elite Argon Medical Nitinol Conical Femoral, 6.5 30 56.5 Optional
Filter Devices Inc., Jugular, or
Plano, TX Brachial
Gunther Tulip Cook Inc., Conichrome Conical, Femoral or Femoral 30 50 Optional
Filter Bloomington, Single Jugular 8.5
IN trapping Jugular 7
Celect Cook Inc., Conichrome Conical, Femoral or 7 30 51 Optional
Platinum Bloomington, Single Jugular
IN trapping
Indications, Techniques, and Retrieval of Inferior Vena Cava Filters 239
(Continued)