Feeds:
Posts
Comments

Archive for the ‘Vena Caval Filters: Device for Prevention of Pulmonary Embolism and Thrombosis’ Category

ClotTriever XL catheter for large blood vessels, i.e., inferior vena ceva on FDA Recall

Posted in Cardiac and Cardiovascular Surgical Procedures, PCI, Peripheral Arterial Disease & Peripheral Vascular Surgery, Vena Caval Filters: Device for Prevention of Pulmonary Embolism and Thrombosis on August 26, 2024| Leave a Comment »

ClotTriever XL catheter for large blood vessels, i.e., inferior vena ceva on FDA Recall

Reporter: Aviva Lev-Ari, PhD, RN

 

The ClotTriever XL catheter, like Inari Medical’s other ClotTriever devices, was designed to treat deep vein thrombosis. Marketed as “a large device for the largest vein,” it was built specifically to target issues found in the vena cava.

The clinical advantage of the ClotTriever system
The CLOUT registry (NCT03575364) is a prospective, single-arm study evaluating outcomes of all-comer patients with proximal lower extremity DVT after thrombectomy with the ClotTriever system. CLOUT enrolled 500 patients from 43 US clinical sites. In-hospital results demonstrated safe and effective thrombus removal with immediate symptom relief. https://www.inarimedical.com/clottriever-system

“Operation of a thrombectomy catheter may cause embolization of some thrombus and/or thrombotic particulate, physician discretion advised,” according to another new warning. “The potential for extensive and/or difficult to treat pulmonary thromboembolism should be carefully considered when ClotTriever XL catheter is used to engage and remove thrombus from large vessels such as the inferior vena cava.”

The news comes after the FDA received several reports of “serious adverse events” due to the device becoming entrapped or blocking arteries in the patient’s lungs. Six deaths and four other patient injuries have been associated with the issue so far.

Inari Medical has published updated instructions for use (IFU) that include additional warnings.

For example, the new IFU tell users to avoid pulling the ClotTriever XL “caudal to cranial” through upper extremity access or jugular vein access. In addition, users should ensure the device is “slowly retracted distally away from the heart” while still tracking sheath position and visualization under fluoroscopy.

SOURCE for Clinical Trials on the device

  1. Dexter D, Kado H, Shaikh A, et al. Safety and effectiveness of mechanical thrombectomy from the fully enrolled multicenter, prospective CLOUT registry. J Soc Cardiovasc Angiog Interv. 2023;2(2):100585.
  2. Shaikh A, et al. Six-month outcomes of mechanical thrombectomy for treating deep vein thrombosis: analysis from the 500-patient CLOUT registry. Cardiovasc Intervent Radiol. 2023; 46(11):1571-1580.

SOURCE for FDA Recall

https://cardiovascularbusiness.com/topics/clinical/vascular-endovascular/fda-announces-recall-inari-medical-catheter-after-6-deaths-4-injuries?utm_source=newsletter&utm_medium=cvb_news

Read Full Post »

Vena Cava Filters: Device for Prevention of Pulmonary Embolism and Thrombosis

Posted in Atherogenic Processes & Pathology, Atrial Fibrilation (a-Fib), Cardiac Pacing and Arrhythmias, Cardiac and Cardiovascular Surgical Procedures, Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH), Coagulation Therapy and Internal Bleeding, congestive heart failure, Frontiers in Cardiology and Cardiovascular Disorders, Heart Failure (HF), Medical Devices R&D and Inventions, Origins of Cardiovascular Disease, Peripheral Arterial Disease & Peripheral Vascular Surgery, Pharmacotherapy of Cardiovascular Disease, Vascular Diseases, Vena Caval Filters: Device for Prevention of Pulmonary Embolism and Thrombosis, tagged , , , , , on October 4, 2016| Leave a Comment »

Inferior Vena Cava Filters: Device for Prevention of Pulmonary Embolism and Thrombosis

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 7/18/2018

 

Original Investigation
Cardiology
July 13, 2018

Association of Inferior Vena Cava Filter Placement for Venous Thromboembolic Disease and a Contraindication to Anticoagulation With 30-Day Mortality

Tyson E. Turner, MD, MPH1; Mohammed J. Saeed, MBChB, MPH2; Eric Novak, MS1; et alDavid L. Brown, MD1
Author Affiliations Article Information
JAMA Network Open. 2018;1(3):e180452. doi:10.1001/jamanetworkopen.2018.0452
Key Points

Question  What is the association of inferior vena cava filter placement with 30-day mortality in patients with venous thromboembolic disease and a contraindication to anticoagulation?

Findings  In this cohort study, using 2 different statistical methods with adjustment for immortal time bias, inferior vena cava filter placement in patients with venous thromboembolic disease and a contraindication to anticoagulation was associated with an increased risk of 30-day mortality.

Meaning  Randomized clinical trials are needed to define the role of inferior vena cava filter placement in patients with venous thromboembolic disease and a contraindication to anticoagulation.

 

Abstract

Importance  Despite the absence of data from randomized clinical trials, professional societies recommend inferior vena cava (IVC) filters for patients with venous thromboembolic disease (VTE) and a contraindication to anticoagulation therapy. Prior observational studies of IVC filters have suggested a mortality benefit associated with IVC filter insertion but have often failed to adjust for immortal time bias, which is the time before IVC filter insertion, during which death can only occur in the control group.

Objective  To determine the association of IVC filter placement with 30-day mortality after adjustment for immortal time bias.

Design, Setting, and Participants  This comparative effectiveness, retrospective cohort study used a population-based sample of hospitalized patients with VTE and a contraindication to anticoagulation using the State Inpatient Database and the State Emergency Department Database, part of the Healthcare Cost and Utilization Project of the Agency for Healthcare Research and Quality, from hospitals in California (January 1, 2005, to December 31, 2011), Florida (January 1, 2005, to December 31, 2013), and New York (January 1, 2005, to December 31, 2012). Data analysis was conducted from September 15, 2015, to March 14, 2018.

Exposure  Inferior vena cava filter placement.

Main Outcomes and Measures  Multivariable Cox proportional hazard models were constructed with IVC filters as a time-dependent variable that adjusts for immortal time bias. The Cox model was further adjusted using the propensity score as an adjustment variable.

Results  Of 126 030 patients with VTE, 61 281 (48.6%) were male and the mean (SD) age was 66.9 (16.6) years. In this cohort, 45 771 (36.3%) were treated with an IVC filter, whereas 80 259 (63.7%) did not receive a filter. In the Cox model with IVC filter status analyzed as a time-dependent variable to account for immortal time bias, IVC filter placement was associated with a significantly increased hazard ratio of 30-day mortality (1.18; 95% CI, 1.13-1.22; P < .001). When the propensity score was included in the Cox model, IVC filter placement remained associated with an increased hazard ratio of 30-day mortality (1.18; 95% CI, 1.13-1.22; P < .001).

Conclusions and Relevance  After adjustment for immortal time bias, IVC filter placement was associated with increased 30-day mortality in patients with VTE and a contraindication to anticoagulation. Randomized clinical trials are needed to determine the efficacy of IVC filter placement in patients with VTE and a contraindication to anticoagulation.

 

EDITORIAL

Requiem for Liberalizing Indications for Vena Caval Filters?

Samuel Z. Goldhaber
http://dx.doi.org/10.1161/CIRCULATIONAHA.116.022730 Published: May 24, 2016

Use of inferior vena caval (IVC) filters has proliferated.

  • In 1979, ≈2000 vena caval filters were inserted.
  • In 1999, the number of IVC filters inserted annually had increased ≈25-fold to 49 000.
  • Retrievable IVC filters were first approved in 2003 and gained popularity rapidly.
  • By 2006, retrievable IVC filters accounted for about half of all IVC filters that were inserted.
  • The largest proportional increase in IVC filter use was subsequently in patients at risk for pulmonary embolism (PE) but who had had neither PE nor deep vein thrombosis (DVT).1

The Controversy by Samuel Z. Goldhaber, MD

Appropriate use of IVC filters is a hot topic. On the one hand,

  • filters hold the promise of reducing PE rates by trapping moderate and large DVT that have detached from the deep veins of the legs and pelvis and that are hurtling toward the heart. On the other hand, we do not have clear-cut definitions of which patients with PE and DVT will benefit most from this technology.
  • an array of complications can ensue, including
  1. caval perforation,2
  2. caval thrombosis,
  3. fracture,
  4. fragment embolization,
  5. intracardiac migration,3
  6. cardiac perforation, and
  7. cardiac tamponade.4

In a systematic review of retrievable IVC filters, only 34% were retrieved, and the majority remained in place permanently. Most of the complications from retrievable filters occurred with long-term use.5

Guidelines

However, it is premature to hammer nails into the coffin and to gather as a medical community for a requiem that celebrates no indication for liberalizing indications for placing an IVC filter. Instead, we need to shift the focus of the questions that we investigate and pour resources into further randomized and observational trials of IVC filter insertion in special highrisk populations.

There remain important groups of patients who may benefit from IVC filters with reduction in PE and PE-associated mortality (Table 2). In some cases, tantalizing data suggest that these populations warrant filters. In other cases, we lack data to guide us. Patients with massive PE—accompanied by cardiogenic shock requiring vasopressors to support blood pressure—are desperately ill. They are clinically unstable. An additional PE under these circumstances can be the fatal blow. Data from the National Inpatient Sample and the International Cooperative PE Registry suggest that filters in these patients may be lifesaving.

Patients with severe PE who undergo acute surgical pulmonary embolectomy are vulnerable to recurrent PE, especially during the early postoperative period where full anticoagulation cannot be immediately implemented. I have had personal experience managing this type of patient where the embolectomy is successful but the patient dies of recurrent PE.19

Table 1. Generally Accepted Consensus Recommendations for IVC Filter Insertion in Patients With VTE

  • Major bleeding on full-dose anticoagulation
  • Major contraindication to full-dose anticoagulation
  • New-onset acute PE (especially recurrent PE) despite well-documented fulldose anticoagulation for an existing VTE

IVC indicates inferior vena caval; PE, pulmonary embolism; and VTE, venous thromboembolism.

 

Table 2. Special Populations Where Benefits of IVC Filter Insertion May Outweigh Risks

  • Massive PE or high-risk submassive PE
  • Surgical pulmonary embolectomy
  • Cancer patients with VTE or at high risk of VTE with concomitant high risk of bleeding if anticoagulated
  • Surgical patients (especially during preoperative evaluation) at high risk of VTE with concomitant high risk of bleeding if anticoagulated

IVC indicates inferior vena caval; PE, pulmonary embolism; and VTE, venous thromboembolism.

http://dx.doi.org/10.1161/CIRCULATIONAHA.116.022730

References

1. Stein PD, Matta F, Hull RD. Increasing use of vena cava filters for prevention of pulmonary embolism. Am J Med. 2011;124:655–661. doi:10.1016/j.amjmed.2011.02.021.

2. Jia Z, Wu A, Tam M, Spain J, McKinney JM, Wang W. Caval penetration by inferior vena cava filters: a systematic literature review of clinical significance and management. Circulation. 2015;132:944–952. doi: 10.1161/ CIRCULATIONAHA.115.016468

3. Owens CA, Bui JT, Knuttinen MG, Gaba RC, Carrillo TC, Hoefling N, Layden-Almer JE. Intracardiac migration of inferior vena cava filters: review of published data. Chest. 2009;136:877–887. doi: 10.1378/ chest.09-0153.

4. Nicholson W, Nicholson WJ, Tolerico P, Taylor B, Solomon S, Schryver T, McCullum K, Goldberg H, Mills J, Schuler B, Shears L, Siddoway L, Agarwal N, Tuohy C. Prevalence of fracture and fragment embolization of Bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade. Arch Intern Med. 2010;170:1827–1831. doi: 10.1001/archinternmed.2010.316.

5. Angel LF, Tapson V, Galgon RE, Restrepo MI, Kaufman J. Systematic review of the use of retrievable inferior vena cava filters. J Vasc Interv Radiol. 2011;22:1522–1530.e3. doi: 10.1016/j.jvir.2011.08.024.

19. Aklog L, Williams CS, Byrne JG, Goldhaber SZ. Acute pulmonary embolectomy: a contemporary approach. Circulation. 2002;105:1416–1419.

Other related articles published in this Open Access Online Scientific Journal include the follwoing:

 

Xarelto (Rivaroxaban): Anticoagulant Therapy gains FDA New Indications and Risk Reduction for: (DVT) and (PE), while in use for Atrial fibrillation increase in Gastrointestinal (GI) Bleeding Reported

https://pharmaceuticalintelligence.com/2012/11/04/xarelto-rivaroxaban-anticoagulant-therapy-gains-fda-new-indications-and-risk-reduction-for-dvt-and-pe-while-in-use-for-atrial-fibrillation-increase-in-gastrointestinal-gi-bleeding-reported/

Venous Thromboembolism (VTE): Blood Clots in Leg and Lungs – No. 3 Cardiovascular Killer Globally – Is Leading Cause of Premature Death and Disability in Hospitals

https://pharmaceuticalintelligence.com/2014/10/13/venous-thromboembolism-vte-blood-clots-in-leg-and-lungs-no-3-cardiovascular-killer-globally-is-leading-cause-of-premature-death-and-disability-in-hospitals/

The Relation between Coagulation and Cancer affects Supportive Treatments

https://pharmaceuticalintelligence.com/2015/10/19/the-relation-between-coagulation-and-cancer-affects-supportive-treatments/

Read Full Post »