Clinical trial NCT00629902: Heart Valve Prosthesis-Patient Mismatch
Official title: Impact of Prosthesis-Patient Mismatch on Clinical Outcomes After Mitral Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Diseases
Keywords: Heart valve prosthesis
Lead sponsor: Florence Nightingale Hospital, Istanbul
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary care clinic

Brief summary: The purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes.

Detailed description: Mitral valve replacement (MVR) is associated with higher short and long term mortality than aortic valve replacement or mitral valve repair. The suboptimal results of MVR underline the importance of identifying and preventing prosthesis- patient mismatch. The effective orifice area (EOA) of prosthetic valves used for MVR is often too small in relation to body size, thus causing a mismatch between valve EOA and transvalvular flow. As a consequence, normally functioning mitral prostheses often have relatively high gradients that are similar to those found in patients with mild to moderate mitral stenosis. Residual pressure gradients across mitral prostheses delay the regression of left atrial and pulmonary arterial hypertension. Pulmonary hypertension may cause rightsided failure and is an important risk factor for morbidity and mortality in patients with cardiovascular diseases. However data about the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcome is inconclusive. Predetermined outcomes will be evaluated in the clinical course of this condition.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years with a clinical condition of mitral valve prosthesis

Exclusion Criteria:

* Evidence of prosthesis valve dysfunction (dehisence, endocarditis or thrombus of prosthetic mitral valve)
* Concomitant aortic valve prosthesis and tricuspid valve prosthesis
* Presence of \> +2 aortic valve regurgitation and/or mild aortic stenosis
* Prosthetic mitral valve replacement operation \< 6 months
* Left ventricular ejection fraction \< 50%
* Chronic obstructive pulmonary disease
* Concomitant hypertrophic cardiomyopathy, atrial septal defect
* Patients with poor ehocardiographic window

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: T.C. Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
state: Sisli
Study officials:
affiliation: T.C. Istanbul Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
name: Saide Aytekin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Totaro P, Argano V. Patient-prosthesis mismatch after mitral valve replacement: myth or reality? J Thorac Cardiovasc Surg. 2007 Sep;134(3):697-701. doi: 10.1016/j.jtcvs.2007.04.031.
citation: Li M, Dumesnil JG, Mathieu P, Pibarot P. Impact of valve prosthesis-patient mismatch on pulmonary arterial pressure after mitral valve replacement. J Am Coll Cardiol. 2005 Apr 5;45(7):1034-40. doi: 10.1016/j.jacc.2004.10.073.
citation: Magne J, Mathieu P, Dumesnil JG, Tanne D, Dagenais F, Doyle D, Pibarot P. Impact of prosthesis-patient mismatch on survival after mitral valve replacement. Circulation. 2007 Mar 20;115(11):1417-25. doi: 10.1161/CIRCULATIONAHA.106.631549. Epub 2007 Mar 5.