Transseptal Approach Versus Conventional Left Atrial Approach for Mitral Valve Procedures

NCT ID: NCT04078100

Last Updated: 2019-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-10-30

Brief Summary

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Study Objectives/Specific Aims Overall Goal: To compare between transseptal approach and the conventional left atrial approach for mitral valve procedures.

* Objective 1: Assess the intraoperative approach related criteria in valve exposure, cardiopulmonary bypass time and intraoperative complications.
* Objective 2: Assess the outcomes and postoperative results.

Detailed Description

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Mitral valve diseases are considered among the most prevalent valvular heart diseases that necessitate surgical intervention.

as the Modern international guidelines substantially recommend mitral valve repair whenever possible there is significant decrease in mitral valve replacement rates.

Cardiothoracic surgeons have to face the problem of Making a decision regarding mitral valve repair, reconstruction or replacement which requires excellent valve exposure for precise anatomical definition and manipulation taking in mind cases with specific anatomical challenges.

Since the beginning of modern cardiac surgery only two basic approaches to the mitral valve have been described by Effler who wrote in 1958 " the actual entry into the left atrium may be accomplished in either of two ways : through the Fossa Ovalis by way of the right atrium or through the posterior interatrial groove " Nowadays median sternotomy is still the most commonly used incision for mitral valve surgery which allows the best exposure for the valve through transseptal incision or through Sandergaard's groove.

Although the latter approach is the preferred method for most surgeons the transseptal approach has been revisited in more recent years in various forms by those seeking better exposure of mitral valve especially in cases with difficult anatomy.

In this paper we try to compare the transseptal approach with the conventional left atrial approach for mitral valve procedures to review previous literatures' results and to clarify the effect of using each of the two approaches in preoperative ,intra and postoperative course .

Conditions

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Mitral Valve Surgical Approaches

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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group A

underwent mitral valve surgery through transseptal approach.

Transseptal approach.

Intervention Type PROCEDURE

surgical approach to the mitral valve through the Fossa Ovalis by way of the right atrium.

group B

underwent mitral valve surgery through conventional left atrial approach.

No interventions assigned to this group

Interventions

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Transseptal approach.

surgical approach to the mitral valve through the Fossa Ovalis by way of the right atrium.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients underwent mitral valve replacement, mitral valve repair, redo mitral valve replacement, combined mitral and tricuspid procedures, combined mitral surgery and coronary arteries bypass graft at cardiothoracic surgery department Assiut University Hospital.

Exclusion Criteria

* Patients with congenital mitral valve diseases .
* patient refused to sign the informed consent to be a part in the research .
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Beshoy Allam Moris

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Thabet, dr.

Role: STUDY_DIRECTOR

general surgery department, AssiutU

Mohamed Mahmoud, dr.

Role: STUDY_DIRECTOR

cardiothoracic department, AssiutU

Central Contacts

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Beshoy Allam, master

Role: CONTACT

+201009471147

Ahmed ELminshawy, prof. dr.

Role: CONTACT

01148185466

References

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Rezahosseini O, Rezaei M, Ahmadi Tafti SH, Jalali A, Bina P, Ghiasi A, Karimi A, Abbasi K, Shirzad M, Davoodi S, Salehi Omran A. Transseptal Approach versus Left Atrial Approach to Mitral Valve: A Propensity Score Matching Study. J Tehran Heart Cent. 2015 Oct 27;10(4):188-93.

Reference Type BACKGROUND
PMID: 26985207 (View on PubMed)

van der Merwe J, Casselman F. Mitral Valve Replacement-Current and Future Perspectives. Open J Cardiovasc Surg. 2017 Jul 13;9:1179065217719023. doi: 10.1177/1179065217719023. eCollection 2017.

Reference Type BACKGROUND
PMID: 28757798 (View on PubMed)

Doty JR, Caine WT. Mitral valve replacement and tricuspid valve repair through a transseptal approach for double-valve endocarditis. Multimed Man Cardiothorac Surg. 2012 Jan 1;2012:mms003. doi: 10.1093/mmcts/mms003.

Reference Type BACKGROUND
PMID: 24414707 (View on PubMed)

Nienaber JJ, Glower DD. Minitransseptal versus left atrial approach to the mitral valve: a comparison of outcomes. Ann Thorac Surg. 2006 Sep;82(3):834-9; discussion 839. doi: 10.1016/j.athoracsur.2006.04.014.

Reference Type BACKGROUND
PMID: 16928494 (View on PubMed)

Santibanez Escobar F, Serrano Gallardo G, Ramirez Marroquin S, Lopez Soriano F, Barragan Garcia R. The transseptal approach for mitral valve replacement revisited. Tex Heart Inst J. 1997;24(3):209-14.

Reference Type BACKGROUND
PMID: 9339510 (View on PubMed)

Other Identifiers

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Transseptal apprroach

Identifier Type: -

Identifier Source: org_study_id

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