Right Ventricular Dysfunction Clinical Trial
Official title:
Right Ventricular Function After Mitral Valve Replacement in Rheumatic Heart Disease Patients With Pulmonary Hypertension: Short Term Follow up
Rheumatic heart disease remains a major health problem in developing countries. It is the
most important sequel of rheumatic fever and occurs in about 30% of patients with rheumatic
fever.Rheumatic heart disease presents with different degrees of pancarditis and associated
valve failure. Involvement of the mitral leaflets can cause mitral regurgitation (MR) or
stenosis and eventually can lead to heart failure. Mitral repair or replacement is therefore
recommended before left ventricular (LV) dysfunction develops.
Study Objectives/Specific Aims Overall Goal: To determine the benefit the patient with
pulmonary hypertension will get from mitral valve replacement as regard function improvement
and remodeling of the right ventricle.
- Objective1: Identify risk factors that are predictive of outcomes.(Type and severity of
Mitral valve pathology , severity of pulmonary hypertension, tricuspid regurge,
preoperative RV dysfunction)
- Objective2: Determine the value of management strategies (Mitral valve replacement in
pulmonary hypertension i.e. : decrease RV pressure overload and enhance RV remodeling)
- Objective3: Assessment of the outcomes clinically & Echocardiographically :
postoperative results during hospital stay and follow up (short term up to 3 months).
In 1994, it was estimated that 12 million individuals had RF and RHD worldwide , and at least
3 million had congestive heart failure (CHF) that required repeated hospital admissions. A
large section of the individuals with CHF required cardiac valve surgery within 5-10 years .
The mortality rate for RHD varied from 0.5 per 100 000 population in Denmark, to 8.2 per 100
000 population in China , and the estimated annual number of deaths from RHD for 2000 was
332000 worldwide . The mortality rate per 100 000 population varied from 1.8 in the WHO
Region of the Americas, to 7.6 in WHO South-East Asia Region. The disability-adjusted life
years (DALYs)1 lost to RHD ranged from 27.4 DALYs per 100 000 population in the WHO Region of
the Americas, to 173.4 per 100 000 population in the WHO South-East Asia Region. An estimated
6.6 million DALYs are lost per year worldwide.
THE PATHOLOGY OF RHEUMATIC MITRAL VALVE DISEASE Rheumatic mitral valves shows a different set
of lesions by comparison with degenerative valves, because of the characteristic inflammatory
process, which results in thickening of the leaflets and other components of the mitral valve
apparatus, of variable degrees, and distorts and impairs the movements of the valve. So, the
disease appears here in two forms - stenosis and regurgitation, or a combination of both.
In the case of valve regurge, the most frequent lesion is prolapse of the anterior leaflet,
which is present in more than 90% of young patients and is most often caused by elongated
chordae to its central and medial areas (A2 and A3). In contrast to degenerative disease,
posterior leaflet prolapse is practically not found, except in cases with ruptured chordae
due to infective endocarditis. On the contrary, this leaflet is often shortened in its width,
sometimes resumed to a very narrow and thick strip of tissue. In more complicated cases, the
chordae may be thick and retracted, as may also be the papillary muscles, and the commissures
may be fused in varying degrees. Often, the leaflets and subvalvular apparatus are a
continuous mass of fibrous tissue. Lastly, the annulus is dilated in 95% of the patients. It
is widely accepted that dilatation occurs essentially in the posterior segment of the
annulus, although there is some evidence that it may also occur in the anterior segment,
especially in dilated cardiomyopathy.
Pulmonary hypertension and valvular heart disease Valvular Heart Disease VHD is a common
etiology of pulmonary hypertension, which may result from many mechanisms as an increase in
pulmonary vascular resistance, pulmonary blood flow, or pulmonary venous pressure. The
chronic rise in pulmonary arterial pressure (PAP) often leads to right ventricular (RV)
pressure overload and subsequent RV failure. When present, PH is a marker of poor outcome in
VHD. Assessment of the presence and severity of Pulmonary hypertension thus has an important
role in the risk stratification and therapeutic management of VHD.
The sure diagnosis of PH related to VHD is based on the following criteria: mean PAP 25 mm Hg
together with an abnormally high pulmonary capillary wedge pressure (PCWP) >15 mm Hg or left
ventricular (LV) end-diastolic pressure >18 mm Hg in the context of significant VHD. When
pulmonary venous congestion is the main determinant of PH, PH is named isolated
post-capillary PH or pulmonary venous hypertension.
PATHOPHYSIOLOGY Increase in LV filling pressure and left atrial (LA) pressure leads to a
passive rise in backward pressure of the pulmonary vein. Persistently elevated pulmonary
venous pressure can favor fragmentation of the structure and result in "alveolar capillary
stress failure," accompanied by capillary leakage and acute alveolar edema. This acute phase
is reversible, but long-term persistence of high pulmonary venous pressure may provocate some
degree of irreversible remodeling of the alveolar capillary membrane, with excessive
deposition of type IV collagen. Plus, chronic elevated pulmonary venous pressure
progressively and passively increases PAP and concomitantly produces pathological changes in
pulmonary veins. and arteries, leading to increased pulmonary vascular resistance . The
pathophysiology of PH in VHD thus involves progressive structural alteration of the pulmonary
vascular bed mediated by the potent vasoconstrictor endothelin-1 . An increase in
pulmonary-arterial vasoconstriction and systolic PAP results into RV dilation and
hypertrophy. The RV failure is associated with tricuspid annulus dilation and an increase in
tricuspid regurgitation severity, which further acerbates RV dysfunction. At the
decompensated phase, systolic PAP can decrease despite the increase in pulmonary vascular
resistance, due to the fall in RV stroke volume related to advanced RV failure.
After treatment, the reversibility of PH depends on the type, severity, and chronicity of
VHD, as well as the underlying pathophysiological adaptations. For instance, in mitral
stenosis (MS), a rapid decrease in PAP is observed after relief of the stenosis, whereas a
longer time could be required in other VHDs, especially when PH is linked to volume overload,
as in mitral regurgitation (MR). Right ventricular function assessment The right ventricle
has long been neglected, yet it is RV function that is strongly associated with clinical
outcomes in many conditions. Although the left ventricle has been studied extensively, with
established normal values for dimensions, volumes, mass, and function, measures of RV size
and function are lacking. The relatively predictable left ventricular (LV) shape and
standardized imaging planes have helped establish norms in LV assessment. There are, however,
limited data regarding the normal dimensions of the right ventricle, in part because of its
complex shape. The right ventricle is composed of 3 distinct portions: the smooth muscular
inflow (body), the outflow region, and the trabecular apical region. Volumetric
quantification of RV function is challenging because of the many assumptions required. As a
result, many physicians rely on visual estimation to assess RV size and function.
The basics of RV dimensions and function were included as part of the ASE and European
Association of Echocardiography recommendations for chamber quantification published in 2005.
This document, however, focused on the left heart, with only a small section covering the
right-sided chambers. Since this publication, there have been significant advances in the
echocardiographic assessment of the right heart. In addition, there is a need for greater
dissemination of details regarding the standardization of the RV echocardiographic
examination .
PERIOPERATIVE ASSESSMENT OF THE RV In cardiac surgery, right heart catheterization and
echocardiography play an essential and complementary role in the assessment of RV structure
and function. Both provide useful information that may help tailor the anesthetic and
surgical approach and provide guidance in the management of hemodynamically unstable
patients. Hemodynamically, Right ventricular dysfunction or failure is usually recognized in
the presence of a right atrial pressure (RAP) _8-10 mm Hg or a RAP to pulmonary capillary
wedge pressure _0.8 (isolated RV failure) and/or a low cardiac index (_2.2 L _ min_1 _ m_2).
Increasing RAP may also be a sign of impeding RV failure. echocardiography also provides
useful information on RV and pulmonary structure, valvular function and pericardial
physiology.
The echocardiographic evaluation of the RV is more challenging than that of the left
ventricle. The main difficulties encountered may be explained by 1) the complex shape of the
RV, 2) heavy apical trabeculations of the RV, which limits endocardial surface recognition,
and 3) the marked load dependence of several indices of RV function. Despite these
limitations, a comprehensive assessment of the RV may provide important data into its
contractility, preload, and afterload.
Lastly and as recommended by the American society of Echocardiography Endorsed by the
European Association of Echocardiography, a registered branch of the European Society of
Cardiology, and the Canadian Society of Echocardiography in 2010 guidelines all studies, the
sonographer and physician should examine the right heart using multiple acoustic windows, and
the report should represent an assessment based on qualitative and quantitative parameters.
The parameters to be performed and reported should include a measure of right ventricular
(RV) size, right atrial (RA) size, RV systolic function (at least one of the following:
fractional area change [FAC], S', and tricuspid annular plane systolic excursion [TAPSE];
with or without RV index of myocardial performance [RIMP]), and systolic pulmonary artery
(PA) pressure (SPAP) with estimate of RA pressure on the basis of inferior vena cava (IVC)
size and collapse.
So in this study we will focus on right ventricular function and performance after performing
Mitral valve replacement to the rheumatic heart disease patients associated with pulmonary
hypertension either mild or severe, to put a hand on the extent of benefit the patient who
developed pulmonary hypertension will get from mitral valve replacement as regard function
improvement and remodeling of the right ventricle and the proper timing of surgery.
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