Edwards Lifesciences is reporting the results of a study comparing traditional mitral valve repair involving a sternotomy to a minimally invasive approach via mini-thoracotomy with the company’s new PORT ACCESS system, an endovascular cardiopulmonary bypass technology. The main results are that the patients are discharged earlier with fewer time spent on the ventilator and in ICU, an important benefit for both the patient’s prognosis and comfort, as well as the financial advantages it brings to hospitals.
From the announcement:
The 171 patients undergoing mitral valve repair with the PORT ACCESS System had total hospital stays approximately 1.5 days less than sternotomy patients (p < 0.001). In these patients, ICU stay was reduced from 82 hours to 44 hours (p < 0.001), a 46 percent reduction. In the same population, the number of patients requiring post-operative ventilation was reduced from 75.6 percent in the sternotomy group to 50.3 percent in the PORT ACCESS group (p < 0.001). Further, substantially fewer PORT ACCESS patients required prolonged ventilation (defined by the Society of Thoracic Surgeons, or STS, as greater than 24 hours): 5.4 percent compared to 11.8 percent with full sternotomy (p=0.039). Trends in the mitral valve replacement data supported the findings in the repair cohort, but due to a smaller patient population size (n=42), statistical significance was not achieved for as many endpoints. One exception was the 64 percent reduction in ICU length of stay from 147 hours in the sternotomy group to 53 hours in the PORT ACCESS group (p=0.016).