What is the clinical evidence from this study?

Study design: Other. Population: Mitral insufficiency (n=11). Intervention: Percutaneous mitral valve repair system based on Alfieri technique. Primary outcome: Acute in-vivo safety and feasibility (leaflet capture, suture placement, and suture-clip deployment).

What question did this study set out to answer?

To evaluate the acute in-vivo safety and feasibility of a novel beating-heart percutaneous mitral valve repair system based on the Alfieri edge-to-edge technique in an animal model.

February 23, 2007Catheterization and Cardiovascular Interventions

Beating‐heart percutaneous mitral valve repair using a transcatheter endovascular suturing device in an animal model

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Key result

A novel percutaneous mitral valve repair system based on the Alfieri technique was safe and feasible, achieving successful leaflet capture and suture-clip deployment in 100% of the 11 pigs tested.

Population

11 pigs (90-100 kgs) with non-diseased mitral valves

Design

Preclinical

Follow-up

Acute (end of procedure)

Authors

TNTasneem Z. NaqviCardiac Imaging MBMaurice BuchbinderInterventional / Structural Cardiology DZDavid ZarbatanyLaguna Research

Discussion

Member takes

Implication

Supports preclinical device development for mitral repair; leaves open human safety and efficacy trials.

Key Points

To evaluate the acute in-vivo safety and feasibility of a novel beating-heart percutaneous mitral valve repair system based on the Alfieri edge-to-edge technique in an animal model.
Under general anesthesia, 11 pigs (90–100 kg) underwent a beating-heart percutaneous Alfieri procedure via femoral vein access and transeptal puncture under fluoroscopy and intracardiac echocardiography.
A vacuum-assisted therapy device captured the free edges of the mitral leaflets, delivered a suture, and secured it using a Nitinol suture clip and fastener catheter.
Leaflet capture, suture placement, and clip deployment succeeded in 11 of 11 animals (100%), with echocardiography confirming a double-orifice configuration in all subjects.
The procedure required a mean procedural time of 18 ± 9 minutes (range: 9–30 minutes) and resulted in a mean blood loss of 67 ± 44 mL (range: 0–125 mL), with no acute cardiac or access-site complications.

Structured PICO

Population

11 pigs (90-100 kgs) underwent a percutaneous Alfieri procedure to evaluate the acute in-vivo safety and feasibility of a novel mitral valve repair system.

Intervention

Percutaneous Alfieri procedure using a transcatheter endovascular suturing device under intracardiac echo and fluoroscopic guidance

Outcome

Acute in-vivo safety and feasibility (successful leaflet capture, suture placement, and suture-clip deployment)safety

A novel transcatheter endovascular suturing device for percutaneous mitral valve repair based on the Alfieri technique is feasible and safe in an acute porcine model.

Limitations

Clinical application in humans needs to be evaluated
Performed in a non-diseased porcine valve model

Cite This Study

Naqvi et al. (2007) studied Mitral insufficiency (n=11). Percutaneous mitral valve repair system based on Alfieri technique was evaluated on Acute in-vivo safety and feasibility (leaflet capture, suture placement, and suture-clip deployment). A novel percutaneous mitral valve repair system based on the Alfieri technique was safe and feasible, achieving successful leaflet capture and suture-clip deployment in 100% of the 11 pigs tested.

synapsesocial.com/papers/6a967b2037dc33ab6afbb820 https://doi.org/10.1002/ccd.21029

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Beating‐heart percutaneous mitral valve repair using a transcatheter endovascular suturing device in an animal model

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Beating‐heart percutaneous mitral valve repair using a transcatheter endovascular suturing device in an animal model

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

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