This randomized controlled trial aims to compare early postoperative outcomes between Minimally Invasive Valve Surgery (MIVS) via right thoracotomy and Conventional Valve Surgery via median sternotomy in patients undergoing elective, isolated mitral or aortic valve surgery. Minimally invasive techniques are believed to reduce postoperative pain, ventilation time, chest drain output, and wound complications, but evidence from Pakistan is limited.
The study will enroll patients of all ages and genders who are scheduled for isolated valvular procedures at Chaudhary Pervaiz Elahi Institute of Cardiology (CPEIC), Multan. Participants will be randomly assigned to undergo either minimally invasive thoracotomy or conventional sternotomy.
Primary outcomes include ventilation time, CPB duration, cross-clamp time, pain scores, and chest drain output. Secondary outcomes include wound healing (Day 7 and 30 days), return to routine activity, echocardiographic evaluation, transfusion requirements, and 30-day mortality. Findings from this study may provide evidence to guide the adoption of minimally invasive valvular surgery techniques in low-resource and developing settings.
Patients of any age and gender.
Undergoing elective, isolated mitral or aortic valve surgery.
MIVS via right thoracotomy, or
Conventional valve surgery , as decided by the operating surgical team.
Emergency or redo cardiac surgeries
Concomitant cardiac procedures (e.g., CABG, multiple valve replacements)
Ejection Fraction <30%
Severe pulmonary hypertension (identified as the mean pulmonary artery pressure (mPAP) exceeding 45 mmHg on echocardiography, as outlined by the AHA guidelines(10).
Parallel
Minimally Invasive Valve Surgery
Procedure/SurgeryParticipants in this group will undergo minimally invasive valve surgery through a right anterolateral thoracotomy. A small 5-7 cm incision will be made in the 4th or 5th intercostal space. Cardiopulmonary bypass will be established using femoral arterial and venous cannulation. A transthoracic aortic cross-clamp will be applied, and cold blood cardioplegia will be administered. The mitral or aortic valve will be accessed through limited thoracic exposure and repaired or replaced using standard techniques. This approach avoids median sternotomy and aims to reduce postoperative pain, ventilation time, transfusion needs, and wound complications.
Conventional Valve Surgery
Procedure/SurgeryParticipants in this group will undergo conventional open-heart valve surgery through a full median sternotomy. Cardiopulmonary bypass will be established using aortic and right atrial cannulation. Standard antegrade cold blood cardioplegia will be administered for myocardial protection. The mitral or aortic valve will be exposed through full sternal access and repaired or replaced following established institutional protocols. This approach represents the traditional surgical method used for valvular heart disease.
Duration of Mechanical Ventilation
The duration of postoperative mechanical ventilation will be measured in hours from the time the patient arrives in the intensive care unit (ICU) after surgery until successful extubation. This outcome evaluates early recovery, respiratory function, and perioperative morbidity following minimally invasive valve surgery versus conventional sternotomy.
Cardiopulmonary Bypass Time
Total duration of cardiopulmonary bypass (CPB) measured in minutes from initiation to termination of bypass during surgery. This evaluates intraoperative efficiency and the impact of minimally invasive versus conventional surgical access on operative time.
Aortic Cross-Clamp Time
Total duration in minutes during which the aorta is cross-clamped during cardioplegic arrest. This outcome assesses technical complexity and myocardial protection demands in each surgical approach.
Chest Drain Output
Total volume of mediastinal and pleural drainage collected in the first 24 hours after surgery, measured in milliliters. This evaluates postoperative bleeding and tissue trauma associated with each surgical technique.
Postoperative Pain Score (NRS)
Pain intensity measured using the Numeric Rating Scale (0-10) at 12 hours and 24 hours postoperatively, assessing the effect of surgical access on postoperative comfort and recovery.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
