Using Pulse Counter Vigileo-Flotrac System in Transapical Off-pump Minimally Invasive Mitral Valve Repair

• Conditions: Mitral Valve Prolapse
• Interventions: Device: Vigileo Flo-trac device

• Registration Number: NCT03506217
• Lead Sponsor: Sakarya University

Brief Summary

Minimally invasive transapical off-pump chordae implantation includes features such as tachycardia, arrhythmia, hemorrhage, sudden hemodynamic changes caused by the device moving in the left ventricle and the atrium, for anesthetists. In this observational study, the investigators presented the investigators's hemodynamic recuperation and anesthesia experiences revealed by cardiac output measurement after transapical mitral valve repair.

Detailed Description

In Sakarya University Educational Research Hospital, perioperative file records of 13 patients who underwent mitral valve repair using the Neochord DS1000 system were retrospectively analyzed. In addition, hemodynamic measurements recorded with the Vigileo Flotrac invasive arterial cardiac output device were evaluated.

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-21
• Last Update Submitted: 2018-04-21
• Study First Posted: 2018-04-24
• Last Update Posted: 2018-04-24
• Study Start: 2018-05-01
• Primary Completion: 2018-08-01
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• All patients that surgical criteria for Neochord implantation with transapical mini-thoracotomy are prolapsus or chordae rupture in posterior, anterior areas or in both leaflets were included.

Exclusion Criteria

• Exclusion criteria are active endocarditis, functional or ischemic mitral insufficiency (MI), excessive calcific valves, leaflet perforation, anemic dilatation and severe left ventricular dysfunction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mitral valve prolaps	Vigileo Flo-trac device	Hemodynamic recovery and anesthesia revealed by invasive arterial cardiac output (CO) measurement (Vigileo Flo-trac device) in 13 cases who underwent mitral valve (MV) repair with the transapical off-pump minimally invasive method in our clinic.

Primary Outcome Measures

Name	Time	Method
invasive arterial cardiac output (CO) measurement	1 month	A Vigileo Flotrac pulse counter invasive arterial cardiac output meter was used for cardiac output measurement.
systemic vascular resistance (SVR)	1mounth	Systemic vascular resistance is used in calculations of blood pressure, blood flow, and cardiac function. Vasoconstriction (i.e., decrease in blood vessel diameter) increases SVR, whereas vasodilation (increase in diameter) decreases SVR
stroke volume variance (SVV)	1 mounth	Stroke volume variation is a naturally occurring phenomenon in which the arterial pulse pressure falls during inspiration and rises during expiration due to changes in intra-thoracic pressure secondary to negative pressure ventilation (spontaneously breathing).
blood pressure	1 mounth	The first (or top) number is your systolic blood pressure. It is the highest level your blood pressure reaches when your heart beats. The second (or bottom) number is your diastolic blood pressure. It is the lowest level your blood pressure reaches as your heart relaxes between beats.

Trial Locations

Locations (1)

Sakarya University Research and Training Hospital; 🇹🇷 Sakarya, Merkez, Turkey