Minimally Invasive Rheumatic Mitral Valve Surgery

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05270590
Collaborator
(none)
20
46.1

Study Details

Study Description

Brief Summary

Early outcome of minimally invasive rheumatic mitral valve surgery through periareolar versus submamary approach

Condition or Disease Intervention/Treatment Phase
  • Procedure: minimally invasive rheumatic mitral valve surgery

Detailed Description

Rheumatic heart valve disease (RHVD) is a post-infectious sequel of acute rheumatic fever resulting from an abnormal immune response to a streptococcal pharyngitis that triggers valvular damage. RHVD is the leading cause of cardiovascular death in children and young adults, mainly in women from low and middle-income countries. It is known that long-term inflammation and high degree of fibrosis leads to valve dysfunction due to anatomic disruption of the valve apparatus.in low and middle-income countries, rheumatic heart valve disease (RHVD) is the leading cause of cardiovascular death in children and young adults When there is severe valvular dysfunction, especially if the patient is symptomatic, surgery is indicated. (1)Traditional mitral valve surgery via a median sternotomy is safe and effective, but it results in a high degree of trauma and a long incision.(2) In the last 2 decades, a minimally invasive (MI) technique has been used widely in cardiac surgery.(3-4) Its prominent advantage in post-surgery recovery and the small incision required makes patients prefer it over a traditional incision.(5-6) Patients underwent Minimal invasive surgery after intravenous anaesthesia combined with general anaesthesia, and their right side was elevated at 30°. After disinfection and draping were performed with sterile protective film fixed to it. Establishing the in vitro pathway: First, venous and arterial access was established. Incision establishment: A 4 to 6 cm incision was opened layer by layer in the chest anterolaterally to the right of the fourth intercostal space (in submamarry vs. peri areolar approach ). A lap-protector was placed. The thoracoscope was inserted near the anterior axillary line of the third intercostal space into the chest with CO2 input. A pericardial longitudinal incision was made under direct vision, extending to the head side and reflexed when reaching the aorta, with the pericardium suspended. Extracorporeal circulation was started, and Chitwood occlusion forceps were inserted into the chest to block the ascending aorta through the fourth intercostal space; the drainage tube of the left atrium perforated the chest through the right midaxillary line between the fifth and sixth intercostal space. 4-0 Prolene was used for the purse-string suturing of the cardioplegia cannula and antegradecardioplegia fluid was performed. After electrocardiograph monitoring showed that electrocardiac activity had stopped, the interatrial groove was freed, the left atrial incision was made parallel to the interatrial groove, and the left atrial drainage tube was inserted. A left atrial retractor was placed and stretched to the surface for fixation through the perforation into the prothorax, and the left atrial incision was retracted in the direction of the sternum. Removal of the damaged mitral valve by endoscopic surgical instruments, and the mitral valve was sutured intermittently. After examination of the valve location and the opening and closing performance of the valve leaf, the left atrial incision was sutured continuously by prolene 4/0. Retrograde cardioplegia perfusion through the tube was initiated for venting and rewarming of the patient started, and the anesthesiologist ventilated the lungs with air to keep the lung lobes full and to relieve the occlusion of the ascending aorta. Cardiopulmonary bypass was stopped gradually and bleeding was stopped; a chest drainage tube was inserted through the hole for the left atrium drainage tube, and the chest was closed.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Early Outcome of Minimally Invasive Rheumatic Mitral Valve Surgery Through Periareolar Versus Submamary Approach
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
group A

periareolar approach

Procedure: minimally invasive rheumatic mitral valve surgery
First, venous and arterial access was established. Incision establishment: A 4 to 6 cm incision was opened in the chest anterolaterally to the right of the fourth intercostal space (in submamarry vs. peri areolar approach ). The thoracoscope was inserted. Bypass started, and Chitwood occlusion forceps were inserted to block the ascending aorta, purse-string suturing of the cardioplegia cannula and antegradecardioplegia fluid was performed, the interatrial groove was freed, the left atrial incision was made. Removal of the damaged mitral valve mostly by endoscopic surgical instruments (not usually there is a chance for repair), and the mitral valve was sutured intermittently. After examination of the valve location and the opening and closing performance of the valve leaf, the left atrial incision was sutured continuously by prolene 4/0. Weaning from bypass start

group B

submamary approach

Procedure: minimally invasive rheumatic mitral valve surgery
First, venous and arterial access was established. Incision establishment: A 4 to 6 cm incision was opened in the chest anterolaterally to the right of the fourth intercostal space (in submamarry vs. peri areolar approach ). The thoracoscope was inserted. Bypass started, and Chitwood occlusion forceps were inserted to block the ascending aorta, purse-string suturing of the cardioplegia cannula and antegradecardioplegia fluid was performed, the interatrial groove was freed, the left atrial incision was made. Removal of the damaged mitral valve mostly by endoscopic surgical instruments (not usually there is a chance for repair), and the mitral valve was sutured intermittently. After examination of the valve location and the opening and closing performance of the valve leaf, the left atrial incision was sutured continuously by prolene 4/0. Weaning from bypass start

Outcome Measures

Primary Outcome Measures

  1. identify of advantages and disadvantages of each approach [1/1/2022 TO 1/1/2025]

    discussing and finding each approachs advantages and disadvantages and comparing with each other

  2. Assess the outcome regarding: -Wound size [1/1/2022 TO 1/1/2025]

    measuring Wound size (in cm ) of each approach

  3. Assess the outcome regarding: -Postoperative pain and patient satisfaction [1/1/2022 TO 1/1/2025]

    measuring postoperative pain and patient satisfaction by pain scale of each approach

  4. assess Wound complication [1/1/2022 TO 1/1/2025]

    assess Wound complication (as infection (superfacial , deep , burst chest )

Secondary Outcome Measures

  1. Assess the outcome regarding: Economic factor [1/1/2022 TO 1/1/2025]

    Assess the outcome regarding: -Economic factor ( ICU stay or hospital stay)

  2. Assess the outcome regarding:Time of procedure [1/1/2022 TO 1/1/2025]

    Assess the outcome regarding:Time of procedure ( time of total bypass time , time for rapid access, time of haemostasis)

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Clinical diagnosis of rheumatic mitral valve

  2. Patient undergoing minimal invasive rheumatic mitral valve surgery

  3. Patient is willing to comply with all follow-up visits.

  4. Willing and able to provide written informed consent and comply with study requirements

Exclusion Criteria:
  1. Ischemic heart disease

  2. Patients need another valve replacement

  3. Redo mitral valve replacement

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Anwar A Atia, MD in cardiothoracic surgery, Professor of cardiothoracic surgery
  • Study Chair: Ahmed N Malik, MD in cardiothoracic surgery, Professor of cardiothoracic surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohammed Rabee Hamed Ahmed, assistant lecture at cardiothoracic department, Assiut University
ClinicalTrials.gov Identifier:
NCT05270590
Other Study ID Numbers:
  • peri areolar MVR
First Posted:
Mar 8, 2022
Last Update Posted:
Mar 8, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022