Pleth Variability Index (PVI) as a Measure of Volume Status During Transcatheter Mitral Valve Repair
Phase: NA
Conditions: Mitral Regurgitation
Sponsor: Henry Ford Health System

Pleth variability index (PVI) as a measure of volume status during transcatheter mitral valve repair 
 
 
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Official Title: Pleth variability index (PVI) as a measure of volume status during transcatheter mitral valve 
repair 
 
 
NCT Number: NCT03993938 
 
 
Document Date: 5/30/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Pleth variability index (PVI) as a measure of volume status during transcatheter mitral valve repair 
 
 
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Study Protocol 
 
The study aims (1) To measure the intraprocedural change in pleth variability index (PVI) during 
transcatheter mitral valve repair (TMVR) and 2. To compare PVI with left atrial pressure (LAP) prior to 
and after mitral clip deployment 
 
The purpose of the study is to determine if pleth variability index (PVI) can be used during transcatheter 
mitral valve repair as a monitor of volume status and understand its importance as a noninvasive 
hemodynamic monitor by comparing it to invasive indices including left atrial pressure. 
 
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. Large volumes of intravenous fluids administered during TMVR may result 
in significant changes in LAP and hemodynamics. Studies indicate that LAP measured immediately 
after transseptal puncture would be significantly different than LAP measured immediately prior to 
MitraClip leaflet grasping. 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. 
 
Transcatheter mitral valve replacement is becoming increasingly popular in the management of mitral 
regurgitation in patients with high operative morbidity and mortality. Accurate fluid management is key 
in hemodynamics in these patients. Current practice is to rely on invasive indices such as left atrial 
pressure which cannot practically be measured in real-time. Based on the principles of PVI, using this 
noninvasive modality can potentially change current practice during TMVR and improve patient 
outcomes with minimal risk. 
 
 
 
Inclusion Criteria: Male and female patients with mitral regurgitation undergoing transcatheter mitral 
valve repair (TMVR) with Mitra-Clip at Henry Ford Hospital - Main Campus.  
 
Exclusion Criteria: MitraClip procedure unsuccessful (defined as no clip deployment and/or procedural 
interruption due to complication), or patients in whom PVI monitoring was not performed due to 
technical issues. 
 
 
 
 
 
 
 
 
    

Pleth variability index (PVI) as a measure of volume status during transcatheter mitral valve repair 
 
 
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Statistical Analysis Plan 
 
 
Study design – Prospective cohort 
 
Sample size – 30 
 
The sample size was calculated based the on the correlation of delta PVI and delta LAP: the null 
hypothesis correlation of 0 and the alternative hypothesis correlation of 0.6 using a two-sided 
hypothesis test with a significance level of 0.05. The power was set at 0.8 and 0.95 to determine a 
possibly sufficient range for sample size. The results indicated that a minimum of 19 and a maximum of 
30 were warranted. Thus, we plan to include a total of 30 patients for this study. 
 
Masimo Radical-7® probe to be attached to patient's finger along with standard ASA monitors at the 
start of procedure. Intraprocedure LAP (v-wave and mean) to be recorded prior to and after MitraClip 
deployment. Data to be analyzed - age, sex, BMI; Preprocedure EF, PAP, rhythm, MR severity; HR, 
SBP, DBP, MAP every 5 minutes; SPV, PPV, PVI every 5 minutes; LAP prior to mitraclip deployment; 
LAP after mitraclip deployment 
 
Patients baseline characteristic and clinical data will be summarized with mean, SD or median and 
interquartile range (IQR) for continuous variables, and frequency and proportion for categorical 
variables. The change for PVI, and LAP between pre and post will be calculated as delta PVI, delta and 
delta LAP, respectively. Spearman correlation coefficient will be used to study the correlation between 
delta PVI and delta LAP. A p-value<0.05 will be considered statistically significant.