Clinical course and prognostic significance of mitral valve insufficiency under LVAD (left ventricular assist device) therapy

Not Applicable

• Conditions: I50.14; I34.0; Mitral (valve) insufficiency

• Registration Number: DRKS00021594
• Lead Sponsor: Klinik für Herzchirurgie, Rhön-Klinikum, Campus Bad Neustadt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-17
• Study Completion: 2020-11-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with an implanted LVAD system (left ventricular support system) and consent form for performing dynamic stress echocardiography and spiroergometry.

Exclusion Criteria

• Significant reduction in performance / deterioration of the general condition compared to the last follow-up examination (climbing stairs from a floor at a moderate pace is no longer possible without a break)
• manifest cardiac decompensation (peripheral edema with weight gain of> 2 kg in the last 1 to 3 days, shortness of breath, persistent tachycardia / tachyarrhythmia with resting frequency> 100 beats / min, deterioration of the kidney / liver parameters with derailment derailment with equally dosed oral anticoagulation)
• ICD triggering (anti-tachycardia pacing or shock delivery)
• LVAD flow <3l / min, frequent suction events, technical alarms
Significant Hb drop, Hb value <10 g / dl (mostly seen after gastrointestinal bleeding, rarely after spontaneous retroperitoneal bleeding with coagulation derailment)
• serious thromboembolic / bleeding complications in the past 3 months (ischemic or hemorrhagic apoplex with persistent neurological deficits)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mitral valve insufficiency at the time of the follow-up examination determined by 2 examination methods: dynamic stress echocardiography for quantification of a hypothesized MI that emerged or increased under load (latent post-LVAD MI), and spiroergometry for determination of the maximum oxygen intake per kg / kg / minute (SvO2) for estimation resilience (cardio-pulmonary reserve).

Secondary Outcome Measures

Name	Time	Method
Survival under LVAD support, frequency of inpatient admission, TAPSE (tricuspid annular plane systolic excursion) as an echo parameter for assessing right ventricular pump function, creatinine and glomerular filtration rate (GFR) as a parameter for the progression of chronic renal failure (cNI).