Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy

Not Applicable

• Conditions: Pulmonary Hypertension
• Interventions: Procedure: Percutaneous Mitral Commissurotomy

• Registration Number: NCT04083729
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-08-29
• Status Verified: 2019-09
• Study Start: 2019-09
• Study First Submitted QC: 2019-09-06
• Last Update Submitted: 2019-09-06
• Study First Posted: 2019-09-10
• Last Update Posted: 2019-09-10
• Primary Completion: 2021-09
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with persistent pulmonary hypertension	Percutaneous Mitral Commissurotomy	Patients with persistent pulmonary hypertension after balloon mitral comisseruotomy
Patients without persistent pulmonary hypertension	Percutaneous Mitral Commissurotomy	Patients without persistent pulmonary hypertension after balloon mitral comisseruotomy

Primary Outcome Measures

Name	Time	Method
Composite of cardiovascular event	Participants will be followed for a minimum follow-up of one month	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