Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair

Henry Ford Health

Status: Completed

Conditions: Mitral Regurgitation

Treatments: Device: PVI measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT03993938

1

Details and patient eligibility

About

Transcatheter mitral valve repair in the form of MitraClip® is a safe and effective alternative to surgical mitral valve repair/replacement in patients with high operative morbidity and mortality risk. Successful MitraClip application depends on intraprocedural quantification of mitral regurgitation and left atrial pressure (LAP) monitoring. The pleth variability index (PVI) is a noninvasive, dynamic index based on analysis of the respiratory variations in the plethysmographic waveform recorded transcutaneously by the pulse oximeter. Studies demonstrate that PVI is accurate in predicting fluid responsiveness in mechanically ventilated adult patients. In this study, we wish to measure PVI during TMVR and correlate with invasive indices such as left atrial pressure (LAP) and stroke volume variation. Our study hopes to provide a real-time non-invasive alternative to invasive indices to better guide fluid management and improve hemodynamics.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients with mitral regurgitation undergoing transcatheter mitral valve repair(TMVR) with Mitra-Clip(R) at Henry Ford Hospital - Main Campus.

Exclusion criteria

• MitraClip(R) procedure unsuccessful (defined as no clip deployment and/or procedural interruption due to complication), concomitant aortic regurgitation or stenosis of moderate or greater degree existed, patients with grade II or above diastolic dysfunction on echocardiography, previous mitral valve intervention (either surgical or percutaneous), patients requiring continuous vasopressor infusions during the procedure, or patients in whom PVI monitoring was not performed due to technical issues, patients with atrial fibrillation, or preprocedure moderate or greater mitral stenosis

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Patients for TMVR

Experimental group

Description:

Patients with severe mitral regurgitation scheduled for TMVR procedure at Henry Ford Hospital - main campus.

Treatment:

Device: PVI measurement