Minimally Invasive Rheumatic Mitral Valve Surgery

Early Outcome of Minimally Invasive Rheumatic Mitral Valve Surgery Through Periareolar Versus Submamary Approach

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatic Mitral Valve Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: mohammed R hamed, becholar in general surgery; Phone Number: 01024631721; Email: x_spiders123@yahoo.com
• Study Contact Backup: Name: Ahmed Elminshawy, MD in cardiothoracic surgery; Phone Number: 01112743943; Email: aelminshawy@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patient undergoing minimal invasive rheumatic mitral valve surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
identify of advantages and disadvantages of each approach	discussing and finding each approachs advantages and disadvantages and comparing with each other	1/1/2022 TO 1/1/2025
Assess the outcome regarding: -Wound size	measuring Wound size (in cm ) of each approach	1/1/2022 TO 1/1/2025
Assess the outcome regarding: -Postoperative pain and patient satisfaction	measuring postoperative pain and patient satisfaction by pain scale of each approach	1/1/2022 TO 1/1/2025
assess Wound complication	assess Wound complication (as infection (superfacial , deep , burst chest )	1/1/2022 TO 1/1/2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the outcome regarding: Economic factor	Assess the outcome regarding: -Economic factor ( ICU stay or hospital stay)	1/1/2022 TO 1/1/2025
Assess the outcome regarding:Time of procedure	Assess the outcome regarding:Time of procedure ( time of total bypass time , time for rapid access, time of haemostasis)	1/1/2022 TO 1/1/2025

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693.
• Antunes MJ. Minimally invasive valve surgery: reality, dream or utopia? J Heart Valve Dis. 1998 Jul;7(4):358-9. No abstract available.
• Takeda M, Konishi T, Fukata M, Matsuzaki K, Furuya K. [Minimally invasive surgery for single valvular heart disease]. J Cardiol. 1999 Oct;34(4):219-23. Japanese.
• Modi P, Hassan A, Chitwood WR Jr. Minimally invasive mitral valve surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2008 Nov;34(5):943-52. doi: 10.1016/j.ejcts.2008.07.057. Epub 2008 Sep 30.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases
• Other Study ID Numbers: peri areolar MVR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No