eaflet abnormalities following surgical, bioprosthetic mitral valve replacement

Conditions: Z95.2
T82.8
Presence of prosthetic heart valve
Other specified complications of cardiac and vascular prosthetic devices, implants and grafts

Registration Number: DRKS00014758

Lead Sponsor: eipzig Heart Institute GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 500

Inclusion Criteria

surgical, bioprosthetic mitral valve replacement between January, 1st 2008 and December 31st 2017

Exclusion Criteria

* female patients with chilbearing potential (period within the past two years)
* known allergy against iodine, iodinie-containing contrast agents, or beta-blocker
* latente or manifest hyperthyreoidism, nodular thyroid disease, Graves' disease
* renal insufficciency (GFR <45l/min/1.73m2)

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a) leaflet thickening together with changes in contrast (hypoattenuated leaflet thickening (HALT), evaluated in long and short axis as reduced leaflet contour and -contrast; <br>b) reduced leaflet motion and/or opening (RELM, hypoattenuation affecting motion, HAM), evaluated as maximum valve opening from the the view that directly faces the prosthesis in volume rendered images, by measuring from the inner margin of the stent frame to the margin of the affected leaflet tip and presenting as the relation between this distance and the maximum distance from the center of the prosthesis to stent frame. The categorization is made as mildly reduced (<50%), moderately reduced (50-70%), and severely reduced (>70%) motion. Reduced leaflet motion of moderat or more is considered clinically relevant and defined as HAM. <br><br>All mentioned variables are acquired during a single follow-up visit.

Secondary Outcome Measures

Name	Time	Method
The secondary measures are collected during a singe follow-up visit, i.e. on the same day as the CT scan. <br>(1) sensitivity and specificity of echocardiography and blood work, and its association with CT;<br>(2) influence of comorbidities (cardiac; non-cardiac; malignancy);<br>(3) influence of medication, in particular with respect to plateled inhibitors and anticoagulation (vitamin-K-antagonists, platelet inhibitors, novel oral anticoagulants);<br>(4) influence of surgical and peri-procedural parameters (indication for surgery, time since surgery, surgical access, size and model of bioprosthesis used)<br>The secondary endpoints are measured using statistical methods following completion of data acquisition.