Clinical trial NCT06696560: Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries
Official title: Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatic Heart Disease With Valvulitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries.
timeFrame: Within 2 years .
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: