Pulmonary Stenosis Clinical Trial
Official title:
Pulmonary Arteriopathy; Evaluation of Invasive Treatments of Peripheral Pulmonary Stenosis in Terms of Right Ventricular Function and Patient Exercise Tolerance
Postoperative stenoses of the pulmonary artery vascular system seldom occur alone; they are
frequently found in connection with congenital heart defects or malformation syndromes. The
resulting increase of afterload represents a serious pressure load for the right ventricle.
Depending on the number and severity of the stenoses, gradual functional right ventricular
failure is to be expected. Due to limited clinical experience, there has not yet been a
consensus concerning the indications for the different therapeutic strategies (balloon
dilatation, stent implantation, surgical dilatation techniques). Up to now, only few
investigators in few centres use stents as therapy. Therefore, systematic multicenter
investigations assessing larger groups of patients undergoing this procedure are not yet
available. The same applies to other novel dilatation techniques, such as the use of the
"cutting balloon" as therapy for rigid valve stenoses.
By comparing and analysing different invasive forms of treatment (balloon dilatation, stent
implantation and surgery), we expect to achieve an optimisation of therapy.
In the study, the outcomes of different strategies as practiced now in German cardiological
centers will be compared and the main factors influencing the results will be determined. On
the basis of a standardized investigation before and one year after the intervention, these
comparisons with respect to the reduction of stenosis and corresponding changes of right
ventricular functional and anatomical changes are carried out correcting for known
confounders. The assessment of the different included invasive and non-invasive diagnostical
procedures with respect to their ability to detect pathological findings and their changes
as result of the treatment is an important secondary target of the study.
For patients with untreated peripheral pulmonary stenoses, the course of disease is
characterised by a chronic pressure load of the right ventricle. In the medium to long term
this can lead to right heart failure and cardiac arrhythmia unresponsive to therapy. The
probability of these events as well as the time of their occurrence depends on the severity
of the stenoses, the duration of stress and a possible additional volume load. Within the
scope of the prospective study introduced here, we intend to characterise the stenoses with
respect to degree and type and to document the treatment success in terms of decrease of
afterload of the right ventricle. In this context, imaging and catheter-based methods as
well as respective functional analyses are to be used to provide evidence of a reduction or
neutralisation of the pulmonary artery stenoses.
Accordingly, the following questions, or corresponding objectives, can be identified as the
base for the conduct of this clinical trial:
- Morphological and functional categorisation of the angiostenoses and standardisation of
the diagnostic procedures. For this purpose, the quantitative criteria for both the
morphological degree of stenosis (lumen constriction) and the functional degree of
stenosis (pressure gradient) are established by means of cardiac catheterisation and
angiography. Non-invasive imaging methods, which have as yet been restricted primarily
to echocardiography, are complemented by the method of spin angiography. Compared to
conventional angiography, this has the advantage of being less invasive and not
involving radiation exposure.
- On the strength of past experience, the implantation of stents can be viewed as a very
promising approach to a treatment with lasting effectiveness of pulmonary artery
stenoses. The stents have the advantage of high radial forces that can be offset
against the elastic recoil of the vessels occurring after sole dilatation. Furthermore,
constrictions that are caused by either kinking of vessels or their compression by
neighbouring structures can be dilated sufficiently by the use of stents.
- With respect to the interconnectedness of all the projects of the Competence Network
for Congenital Heart Defects, one essential aspect is the standardisation of diagnostic
methods of evaluating right ventricular function. The data obtained during the study
are to provide the basis for the development of diagnostic guidelines.
- Concerning evaluation, particular attention is paid to the patients' self-assessment
with respect to their exercise tolerance. In this context, it is a matter of interest
to what degree the patients' subjective maximum stress and therefore their quality of
life correlate with the objective measurement parameters. The anticipated results are
of direct clinical significance for the patients, as they aim at medium to long-term
relief of the right ventricle, which may effect a decrease in morbidity and therefore
an improvement of the quality of life. This is of particular importance with regard to
the fact that there will be a continuously increasing number of patients with
congenital heart defects reaching adulthood.
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