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SENTINEL Clinical Data

Every patient deserves protection from disabling stroke

STS/ACC TVT Registry

Impact of Cerebral Embolic Protection Devices on Disabling Stroke after TAVR: Results from the TVT Registry1

Study Objectives

  • To describe updated temporal trends and site-level variability in use of SENTINEL among patients undergoing TAVR in the US.
  • To use real-world data to investigate whether use of SENTINEL is associated with reduction in disabling stroke in patients undergoing TAVR in contemporary practice.

Study Design

General Design:  Observational retrospective study of the relationship between use of SENTINEL and TAVR outcomes

Data Source: STS/ACC TVT Registry

Inclusion Criteria: First isolated Transfemoral TAVR between 1/2018 and 6/2023; includes all TAVR devices, bicuspid valve, valve-in-valve procedures

Exclusion Criteria: Emergent procedures; alternative access; sites performing <20 TAVR/yr; CEP other than SENTINEL

Primary Endpoint: In-hospital disabling stroke

Key Points

  • The STS /ACC TVT Registry Stroke data were presented as a Late- Breaking Clinical trial at NY Valves on Wednesday, June 5th, 2024 by Dr. David Cohen from St. Francis Hospital and Dr. Neel Butala from the Rocky Mountain Regional VA Medical Center, leaders of this Investigator- Sponsored Research (ISR) study.
  • Results from a prior TVT Registry analysis2 (>120K TAVR patients), and from the PROTECTED-TAVR3 trial, examining the benefits of using SENTINEL during TAVR, generated inconclusive findings related to all-stroke. Therefore, the present study (observational, retrospective study), using the TVT registry was designed to investigate whether the use of SENTINEL is associated with reduction in disabling stroke in patients undergoing TAVR in contemporary practice.  
    • The STS/ACC TVT registry collects data on patients’ demographics, comorbidities, and outcomes in the US outside of clinical trials. The study population consisted of N=414,649 TAVR patients of whom 53,389 (12.9%) received a SENTINEL between 1/2018-6/2023. The primary outcome was in-hospital disabling stroke. A proxy definition of disabling stroke – defined as non-home discharge - was validated and used for the analysis.


Analytic Approaches

Primary: Instrumental Variable Analysis

  • Technique originally developed in economics that takes advantage of “natural experiments” to approximate randomization
  • Under appropriate assumptions, can account for both measured and unmeasured confounding and support causal inference
  • Instrument = site-level preference for CEP use during the calendar quarter

Secondary: Propensity Score Weighting

  • Propensity score to predict CEP use developed based on 32 demographic, clinical, and hospital-level characteristics
  • Risk-adjusted comparisons performed using overlap propensity weighting

Main Study Findings

  • To evaluate the association between SENTINEL use and disabling stroke, an instrumental variable analysis (IV) with site-level preference for SENTINEL use as the instrument was performed. In addition, a propensity score-based comparison (propensity weighting, PW) was performed as a secondary analysis.  
  • SENTINEL use was associated with a small, borderline significant reduction in disabling stroke in both IV analysis (RR 0.87; 95% CI: 0.73-1.00) and PW analysis (OR 0.79; 95% CI: 0.70-0.90) but was not associated with a reduction in non-disabling stroke.
  • In subgroup analyses, the benefit of SENTINEL was greater among patients with prior stroke versus those without (interaction p<0.05 for IV and PW).


  1. In this large observational study, it was found that SENTINEL use was associated with a small, borderline statistically significant reduction in the risk of stroke associated with death or a discharge to a non-home location (a proxy for disabling stroke) that was at the lower bound of what was observed in the PROTECTED-TAVR trial.
  2. The relative risk reduction in disabling stroke with SENTINEL use was amplified among the subset of patients with prior stroke.
  3. These findings provide evidence that supports a true clinical benefit of SENTINEL use for patients undergoing TAVR, limited to prevention of disabling stroke 


Study objectives

To demonstrate that use of the SENTINEL CPS significantly reduces the risk of peri-procedural stroke (≤ 72-hours) after TAVR.

The PROTECTED TAVR Study is the largest randomized TAVR trial to date with 3,000 patients enrolled at >50 global sites who were randomized 1:1 – patients protected with SENTINEL vs. no use of SENTINEL during TAVR. All risk categories were eligible for inclusion, including low risk patients and all commercially available valves included as part of the trial.

Primary Endpoint: All Stroke  (hemorrhagic, ischemic, or undetermined status; disabling or non-disabling) through 72-hours post TAVR procedure or hospital discharge.

Transient ischemic attack (TIA) and delirium were also reported on as part of the secondary neurological endpoints.

All patients enrolled in the trial underwent neurological examination at baseline and post TAVR procedure (discharge or 72-hours, whichever came first). This assessment was performed by a neurology professional (board certified/board eligible neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner).

Study design
*Any commercially available TAVR device; ‡ Neurological examination at baseline, and post-procedure and through 72 hours after TAVR or discharge (whichever comes first), performed by a neurology professional (board certified/board eligible neurologist, neurology fellow, neurology physician assistant, or neurology nurse practictioner)


The primary endpoint did not meet statistical significance, but the data demonstrated a numerical trend towards a lower rate of stroke in patients treated with the SENTINEL device, representing a 21% relative risk reduction in all stroke through 72-hours or time of hospital discharge.

A secondary analysis demonstrated a statistically significant 60% relative risk reduction in disabling stroke through 72-hours or time of hospital discharge in patients treated with the SENTINEL device.


Strong safety profile

The SENTINEL CPS demonstrated excellent safety with high rates of device delivery/retrieval (94.4%) and very low rates of vascular complications (0.1%).1.   Data showed a 21% relative risk reduction in all stroke and a 60% significant relative risk reduction in disabling stroke through 72-hours. See the study.


Safe and effective device delivery


Low access site complications

Stroke persists as an indiscriminate risk

It is impossible to predict which TAVR procedures will dislodge embolic debris, and when it will cause disabling stroke. 4 minutes per procedure are enough to achieve safe & effective device delivery.

Every patient is a candidate for protection from disabling stroke

The effect of SENTINEL on disabling stroke was consistent across patients' subgroups.

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Panel Discussion PROTECTED TAVR Trial

This panel of experts discuss the current cerebral embolic protection (CEP) landscape, the PROTECTED TAVR trial results and what is next for CEP.


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SENTINEL Indication for Use

The SENTINEL Cerebral Protection System is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.

The diameters of the arteries at the site of filter placement should be between 9.0 mm – 15.0 mm for the brachiocephalic and 6.5 mm – 10.0 mm in the left common carotid.


1. Neel Butala et al. Transcatheter Aortic Valve Replacement: Updated Results from the STS/ACC TVT Registry. Circulation Interventions. 2024.

2. Neel Butala et al. Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results from the TVT Registry. Circulation. 2021

3. Samir R. Kapadia et al. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2022

4. Kapadia, S. PROTECTED TAVR Trial data presented at TCT 2022.

5. Boston Scientific data on file.

All photographs taken by Boston Scientific. Illustrations for informational purposes only – not indicative of actual size or clinical outcome.

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