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April 3, 2020Journal of Cardiothoracic SurgeryOpen Access

Epicardial left atrial appendage occlusion with a new medical device: assessment of procedural feasibility, safety and efficacy in a large animal model

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Key result

The TigerPaw Pro device achieved 100% successful deployment and complete appendage closure without procedural adverse events in a preclinical canine model.

Why the study?

Does the TigerPaw Pro device provide safe and effective epicardial left atrial appendage occlusion in a canine model?

Population

9 hounds (translational canine model)

Design

Preclinical

Authors

MEMaximilian Y. EmmertMFMichael S. FirstenbergAMArthur T. Martella

Discussion

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Overview

Supports preclinical feasibility of TPP for epicardial LAAO; leaves open translation to human AF patients pending clinical trials.

Structured PICO

Does the TigerPaw Pro device provide safe and effective epicardial left atrial appendage occlusion in a canine model?

P
Population
9 hounds aged 6.5 to 11 months evaluated in an acute preclinical beating-heart model for epicardial left atrial appendage occlusion.
I
Intervention
Epicardial left atrial appendage occlusion (LAAO) using the TigerPaw Pro (TPP) device (20 devices deployed)
O
Outcome
Procedural usability, safety (adverse events via direct inspection and imaging), and efficacy (device positioning, residual stumps, completeness of closure)safety

The TigerPaw Pro device demonstrated procedural feasibility, safety, and efficacy for epicardial left atrial appendage occlusion in a preclinical canine model.

Limitations

  • Acute study with no long-term follow-up regarding safety and durability of appendage closure.
  • Preclinical animal model with a limited number of surgeons and devices used, which may not represent the full range of clinical conditions.
  • All animals were fully heparinized, limiting the ability to observe clot formation along the closure line.

Cite This Study

Emmert et al. (2020) studied Atrial fibrillation (translational model) (n=9). TigerPaw Pro (TPP) device was evaluated on Complete closure of appendage ostia. The TigerPaw Pro device achieved 100% successful deployment and complete appendage closure without procedural adverse events in a preclinical canine model.

synapsesocial.com/papers/6ab627264dfd64f4ba564bc5https://doi.org/10.1186/s13019-020-01096-0
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