Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy

Study Overview
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Brief Summary
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To identify clinical, echocardiographic, and hemodynamic parameters which can predict persistent PH after PMC, and also to determine the impact of persistent PH on the clinical outcomes.

Detailed Description
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Pure mitral Stenosis develops in approximately 40% of all patients with rheumatic heart disease, and is frequently complicated by Pulmonary hypertension (PH). Pulmonary hypertension influences symptomatology and long-term prognosis. Percutaneous Mitral Commissurotomy (PMC), was first described in 1984, has good results and is performed by antegrade access to the mitral valve through trans-septal puncture by one of various techniques (e.g. Inuoe, and multitrack system). Pulmonary artery pressures (PAP) decrease following PMC. The improvement in pulmonary hypertension after PMC is explained by the improvement in the mitral valve area and subsequent decompression of left atrium (LA) and pulmonary venous beds. Even though there have been studies showing excellent results following PMC in all grades of PH, nonregression of PH following PMC is not uncommon. The component of PAP contributed by the passive transmission of the elevated LA pressure regresses immediately after a successful PMC proportional to the reduction in transmitral gradient. The PH contributed by pulmonary arteriolar constriction slowly comes down over weeks or a few months, But a fixed component due to pulmonary vascular disease usually persists.

Official Title
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Predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy and Its Impact on Clinical Outcomes

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Procedure: Percutaneous Mitral Commissurotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe mitral stenosis (mitral valve area ≤1.5cm). Significant dyspnea. Favorable anatomical characteristics for PMC as assessed by transthoracic echocardiography Exclusion Criteria: Significant mitral regurgitation (≥ grade II/IV). Bilateral commissural calcification. Presence of other lesions which need open heart surgery. Wilkins' score > 12. Persistent LA thrombus despite adequate anticoagulation. End stage renal or liver disease. Patients with severe COPD and other chest problems that might be complicated by pulmonary hypertension per se.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: predictors of Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with persistent pulmonary hypertension<br>Patients with persistent pulmonary hypertension after balloon mitral comisseruotomy | Procedure: Percutaneous Mitral Commissurotomy<br>* Percutaneous mitral commissurotomy is performed by experienced interventional cardiologists using the Inoue balloon or multitrack technique. During the procedure, conventional hemodynamic parameters are monitored. A successful immediate result is defined as a mitral valve area > 1.5 square cm with less than moderate to severe mitral regurgitation.<br>* Other names: Percutaneous mitral valvuloplasty;|
| Active Comparator: Patients without persistent pulmonary hypertension<br>Patients without persistent pulmonary hypertension after balloon mitral comisseruotomy | Procedure: Percutaneous Mitral Commissurotomy<br>* Percutaneous mitral commissurotomy is performed by experienced interventional cardiologists using the Inoue balloon or multitrack technique. During the procedure, conventional hemodynamic parameters are monitored. A successful immediate result is defined as a mitral valve area > 1.5 square cm with less than moderate to severe mitral regurgitation.<br>* Other names: Percutaneous mitral valvuloplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of cardiovascular event | Composite of cardiovascular mortality, cerebral infarction, systemic embolic events ,RV failure ,MV re stenosis that occurred during follow-up, and PMC-related complications; procedural mortality and urgent MV surgery. parameters changes from base line study and after follow up as MVA in cm 2,PASP in mmHg,LAP in mmHg,LVEP in mmHg,PVR in wood unit | Participants will be followed for a minimum follow-up of one month |