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.

Valvular heart disease is a significant contributor to cardiovascular morbidity worldwide and often requires surgical intervention. Although median sternotomy provides excellent exposure for valve repair and replacement, it is associated with increased surgical trauma, prolonged recovery time, higher postoperative pain, and cosmetically visible scarring.

Minimally Invasive Valve Surgery (MIVS) through a right thoracotomy has emerged as a promising alternative approach, offering advantages such as smaller incisions, reduced postoperative discomfort, shorter hospitalization, and improved cosmetic outcomes-without compromising procedural safety. International evidence demonstrates comparable mortality and valve repair quality between the two techniques, with additional benefits favoring minimally invasive approaches such as reduced transfusion needs and fewer sternal wound complications. However, data from Pakistan remain sparse.

This randomized controlled trial is designed to evaluate the early postoperative outcomes of MIVS versus conventional sternotomy in a tertiary cardiac surgery center in Pakistan. Eligible patients undergoing elective, isolated mitral or aortic valve surgery will be randomized using a computer-generated sequence to one of two groups:

Group A (MIVS): Right anterolateral thoracotomy with femoral cannulation and transthoracic aortic clamping.

Group B (Sternotomy): Median sternotomy with standard central cannulation.

Both groups will receive standardized anesthesia, cardiopulmonary bypass protocols, myocardial protection strategies, and postoperative ICU care. The surgical procedures will be performed by experienced cardiac surgeons, and all perioperative variables will be recorded using a structured proforma.

Primary Outcomes

Cardiopulmonary bypass (CPB) time

Aortic cross-clamp time

Duration of mechanical ventilation

Postoperative pain score (NRS at 12 and 24 hours)

Total chest drain output in the first 24 hours

Secondary Outcomes

PRBC transfusion requirement

Wound condition on postoperative day 7

Echocardiographic findings before discharge and at 30 days

Return to routine daily activity by 30 days

30-day all-cause mortality

Patients will be followed for 30 days after surgery. Data will be analyzed using IBM SPSS v25. Continuous variables will be compared using an independent samples t-test, while categorical variables will be assessed via the Chi-square test. A p-value of <0.05 will be considered statistically significant.

This study aims to provide local evidence comparing the two surgical approaches and help determine whether minimally invasive valve surgery should be more widely adopted as a preferred option in tertiary cardiac surgical practice.

Inclusion Criteria:

• Patients of any age and gender.

• Undergoing elective, isolated mitral or aortic valve surgery.

• Considered suitable for either:

  • MIVS via right thoracotomy, or
  • Conventional valve surgery , as decided by the operating surgical team.

• Patients giving written informed consent.

Exclusion Criteria:

• 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).
• Active systemic infections or sepsis at the time of surgery
• Refusal to participate in the study

De-identified individual participant data (IPD) related to the main study outcomes may be shared. This may include the anonymized dataset for ventilation time, postoperative pain scores, cardiopulmonary bypass time, cross-clamp time, chest drain output, wound condition assessments, transfusion requirements, echocardiographic follow-up findings, and 30-day outcomes. No identifiable data, images, or operative videos will be shared.

De-identified IPD and supporting study documentation will be available six months after publication of the main study results and will remain accessible for up to three years thereafter. Access beyond this time frame may be granted upon reasonable request and approval by the primary investigator and the institutional review board.

Access to de-identified IPD will be granted to qualified researchers affiliated with academic, clinical, or scientific institutions for purposes of meta-analysis, systematic review, or secondary methodological evaluation. Requests must include a brief research proposal and data use agreement. Approved researchers will receive data through a secure, password-protected institutional repository or encrypted email transfer. No commercial use will be permitted.