Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries

To compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according to inclusion criteria.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatic Heart Disease With Valvulitis
• Intervention / Treatment: Other: Minimal Invasive Approaches in Aortic surgeries.

Detailed Description

1. It has been demonstrated that minimally invasive aortic valve replacement (MIAVR) approaches are safe and effective for the treatment of aortic valve diseases. To date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. This makes such approaches an appealing choice also for frail patients [obese, aged, chronic obstructive pulmonary disease (COPD)(1).
2. Minimally invasive aortic valve replacement (MIAVR) has been increasingly accepted in the surgical community as a potential alternative to conventional sternotomy, with advantages of reduced trauma, improved cosmotic and reduced hospitalization(2).
3. The Mini sternotomy (MS) approach represents the most common technique used for Minimally invasive AVR. The MS approach is achieved through 6 to 10cm midline vertical skin incision, performing a partial J sternotomy at the third to fifth intercostal space (3). MIAVR via right mini thoracotomy (RT) is performed through five to seven cm skin incision placed at the level of the second intercostal space without rib resection. After sacrificing the right internal thoracic artery(4).
4. Despite these excellent results, there have been an increasing number of cases performed via minimally invasive aortic valve replacement (MIAVR). This approach has now become an established alternative to FS in order to reduce the "invasiveness" of the surgical procedure, while maintaining the same efficacy, quality and safety of a conventional approach (5).

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients with isolated Aortic valve and subvalvular disease.
2. sexes included with acceptance of patients to participate in this study and approval of Ethical Committee.

Exclusion Criteria:

1. Patients ages who less than 16 yrs and more than 60yrs.
2. Emergent open heart surgery.
3. Patients with current Infective endocarditis.
4. Patients with chest deformity pectus excavatum or carinatum due to difficult access.
5. The patient refused to sign the informed consent to participate in the research.
6. Patients with Aortic root abscess or Aortic dilatation at root or ascending parts.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.	Other: Minimal Invasive Approaches in Aortic surgeries.; Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.	To reduce operation duration,so less hospital stay period. Echocardiography assessment intraoperative and postoperative.	Within 2 years .

Collaborators and Investigators

• Sponsor: Yahia Abd almonem Sayed

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 16, 2024
• First Posted (Estimated): November 20, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 16, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Rheumatic Fever; Heart Diseases; Rheumatic Heart Disease
• Other Study ID Numbers: AssiutU 1

Drug and device information, study documents

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