A randomized controlled trial (PAMI trial) on our new trend periareolar minimally invasive (PAMI) technique versus inframammary approach for minimally invasive cardiac surgery

Abstract
Background
A minimally invasive approach has become standard for mitral valve surgery. The periareolar approach has grown in popularity regarding the cosmesis for patients. We have adopted a new modification to the periareolar approach: the periareolar minimally invasive (PAMI) technique. The objectives of the current study are to test the hypothesis that the PAMI approach is more feasible and safer than the inframammary approach in addition to identify risk factors and assess outcomes of both periareolar and inframammary approach.

Methods
A randomized controlled trial of 3 months compared the PAMI technique to the inframammary approach for minimally invasive cardiac surgery.

Results
A total of 102 patients were enrolled and randomized into two groups: 53 received minimally invasive cardiac surgery through the periareolar approach, and 49 were the control group using the inframammary approach.
Using intention-to-treat analysis, the periareolar approach was superior to the inframammary approach in surgical site infection (two cases in comparison to 8 with P = 0.004), and the number needed to treat for effectiveness was 8.
No early deaths occurred, 97 cases (95.1%) needed no reoperation, and 5 cases (4.9%) were reopened for bleeding. The primary endpoints compared were the duration of procedure, duration of mechanical ventilation, amount of bleeding, ICU stay, and hospital stay. We found no statistically significant differences between the groups.
At 3 months, the secondary endpoints evaluated were the rate of surgical site infection, respiratory complications, groin complications, pericardial effusion, breast hematoma, and cosmoses using a Likert scale. We found no statistically significant difference between the groups, except for surgical site infection (P = 0.004) and cosmesis (P< 0.001).

Conclusions
The results of this PAMI trial are suggestive that the PAMI technique is most probably applicable for the right side of the heart, such as in atrial septal defect closure, tricuspid disease, and mitral valve surgery.

Trial registration
PAMI Trial NCT04726488 Registered January 27, 2021