The rationale of using cerebral embolic protection devices during transcatheter aortic valve implantation

Şimşek, Cihan; Schölzel, Bastiaan E.; Heijer, Peter den; Vos, Jeroen; Meuwissen, Martijn; Branden, Ben Van den; Ijsselmuiden, Alexander

doi:10.1007/s12471-020-01380-7

Cited by 7 publications

(7 citation statements)

References 12 publications

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“…Regarding Sentinel’s cost-effectiveness, estimations show that the cost of preventing a single stroke or death is around 60,000 USD [ 39 ]. As the Sentinel device costs approximately 2800 USD, according to Giustino et al, a total amount of 61,600 USD should be spent to prevent one stroke or death.…”

Section: Discussionmentioning

confidence: 99%

Feasibility and Safety of Cerebral Embolic Protection Device Insertion in Bovine Aortic Arch Anatomy

Tagliari

Ferrari

Haager

et al. 2020

JCM

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Background: Cerebral embolic protection devices (CEPDs) have emerged as a mechanical barrier to prevent debris from reaching the cerebral vasculature, potentially reducing stroke incidence. Bovine aortic arch (BAA) is the most common arch variant and represents challenge anatomy for CEPD insertion during transcatheter aortic valve replacement (TAVR). Methods: Cohort study reporting the SentinelTM Cerebral Protection System insertion’s feasibility and safety in 165 adult patients submitted to a transfemoral TAVR procedure from April 2019 to April 2020. Patients were divided into 2 groups: (1) BAA; (2) non-BAA. Results: Median age, EuroScore II, and STS score were 79 years (74–84), 2.9% (1.7–6.2), and 2.2% (1.6–3.2), respectively. BAA was present in 12% of cases. Successful two-filter insertion was 86.6% (89% non-BAA vs. 65% BAA; p = 0.002), and debris was captured in 95% (94% non-BAA vs. 95% BAA; p = 0.594). No procedural or vascular complications associated with Sentinel insertion and no intraprocedural strokes were reported. There were two postprocedural non-disabling strokes, both in non-BAA. Conclusion: This study demonstrated Sentinel insertion feasibility and safety in BAA. No procedural and access complications related to Sentinel deployment were reported. Being aware of the bovine arch prevalence and having the techniques to navigate through it allows operators to successfully use CEPDs in this anatomy.

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Section: Discussionmentioning

confidence: 99%

Feasibility and Safety of Cerebral Embolic Protection Device Insertion in Bovine Aortic Arch Anatomy

Tagliari

Ferrari

Haager

et al. 2020

JCM

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“…By 2025, there will be an estimated 280,000 TAVR procedures performed worldwide and the total market will exceed $8 billion. Although this highly promising treatment modality results in less morbidity, shorter time to recovery and similar mortality rates, it is still associated with one of the most devastating and feared complications: cerebral embolism, which in turn may cause stroke [15]. Stroke is associated with a 6-fold increase in mortality in TAVR cohorts, a moderate to severe permanent disability in up to 40% of survivors [5], a 4.7-fold increased risk of permanent work disability [2], social isolation and significant financial strain in 80% of stroke survivors [11], and an increased risk of readmission in patients with stroke after cardiac catheterization [16].…”

Section: What Is the Relation Between Tavr And Stroke?mentioning

confidence: 99%

Performance assessment of an electrostatic filter-diverter stent cerebrovascular protection device

Eguzkitza

Oks

Navia

et al. 2023

Preprint

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Stroke is the second leading cause of death worldwide. Nearly two-thirds of strokes are produced by cardioembolisms, and half of cardioembolic strokes are triggered by Atrial Fibrillation (AF), the most common type of arrhythmia. A more recent cause of cardioembolisms is Transcatheter Aortic Valve Replacements (TAVRs), which may onset post-procedural adverse events such as stroke and Silent Brain Infarcts (SBIs), for which no definitive treatment exists, and which will only get worse as TAVRs are implanted in younger and lower risk patients. It is well known that some specific characteristics of elderly patients may lower the safety and efficacy of anticoagulation therapy, making it a real urgency to find alternative therapies. The device introduced in this manuscript offers an anticoagulant-free method to prevent stroke and SBIs, imperative given the growing population of AF and elderly patients. This work analyzes a design based on a patented medical device, intended to block cardioembolisms from entering the cerebrovascular system, with a particular focus on AF, and potentially TAVR patients. The study has been carried out using computational fluid dynamics coupled with Lagrangian particle tracking to analyse the efficacy of a novel patented medical device intended to block cardioembolisms from entering the cerebrovascular system, with a particular focus on AF, and potentially TAVR patients. The studied device consists of a strut structure deployed at the base of the treated artery. Particles of different sizes are used to model dislodged debris, which could potentially lead to cerebral embolisms if transported into these arteries. The device demonstrated a two-fold mechanism for filtering emboli: while the smallest particles are deflected by electrostatic repulsion, avoiding microembolisms, which could lead to cognitive impairment, the largest ones are mechanically filtered since they cannot fit in between the struts, effectively blocking the full range of particle sizes analyzed in this study.

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“…The third generation Sentinel device received FDA approval in 2017. It can be inserted via a 6 French (F) sheath in the right radial (preferred) or brachial artery and it is easy to use with deployment achieved in less than 10 minutes in 90% of the cases [27][28][29]. The delivery system contains two filter baskets (140 μm pores), the first filter is placed in the brachiocephalic trunk and the second filter in the left common carotid artery.…”

Section: Sentinel Cepdmentioning

confidence: 99%

“…The TriGUARD system is an embolic deflector device which consists of a temporary, single-use, biocompatible nitinol filter mesh (130 x 250 μm pores) on a stabilizing frame [27]. After delivery via a 9F transfemoral sheath the device is deployed in the aortic arch under fluoroscopic guidance.…”

Section: Triguard Embolic Deflector Devicementioning

confidence: 99%

The Role of Cerebral Embolic Protection in Transcatheter Aortic Valve Replacement

2021

Journal of Clinical Cardiology

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In transcatheter aortic valve replacement (TAVR), stroke remains one of the most devastating complications. As a result, cerebral embolic protection devices (CEPD) have been developed to prevent cerebral embolization in order to lower the stroke risk. Emboli can either be filtered or deflected depending on the type of CEPD. The goal of this review is to provide an overview of all currently available CEPD and to discuss the results of the most relevant studies concerning cerebral embolic protection in TAVR.

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The rationale of using cerebral embolic protection devices during transcatheter aortic valve implantation

Cited by 7 publications

References 12 publications

Feasibility and Safety of Cerebral Embolic Protection Device Insertion in Bovine Aortic Arch Anatomy

Feasibility and Safety of Cerebral Embolic Protection Device Insertion in Bovine Aortic Arch Anatomy

Performance assessment of an electrostatic filter-diverter stent cerebrovascular protection device

The Role of Cerebral Embolic Protection in Transcatheter Aortic Valve Replacement

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