Minimally invasive surgical procedures (MIS) may be beneficial over conservative full sternotomy (FS) aortic valve replacement (AVR). A new class of aortic valve prostheses has been developed for rapid-deployment AVR (RDAVR). In a recent study published in The Annals of Thoracic Surgery, a team of researchers from Germany report the results of a randomized, multi center trial comparing the outcomes for MIS-RDAVR with those of conventional FS-AVR.
Aortic valve replacement (AVR) through a full sternotomy (FS) has been the gold standard for aortic stenosis treatment. MIS-AVR reduces trauma and aims to achieve decreased postoperative pain and ventilation time, less blood loss, faster recovery, and better aesthetic outcomes, however, the technique has been slow to gain clinical application momentum, at least in part because of the technically more demanding nature of accessing the aortic valve through a smaller access portal, which may in turn lead to prolonged procedural times.
Prolonged cross-clamp time during cardiac surgical procedures correlates with major postoperative morbidity and mortality in both low- and high-risk patients. As a result, enhanced MIS procedural efficiency and reduced procedural times may be of importance for improved clinical outcomes postoperatively. Recent advancements in bioprosthetic valve design have introduced new technologies to facilitate MIS approaches.
Rapid deployment AVR (RDAVR) represents another new development in this area and consists of positioning the valve with a pre crimped subannular skirt frame into the annulus, then balloon deploying the frame, however, there are no randomized studies evaluating the efficacy of this technique.
To address this clinical unmet issue, in the study titled “A Randomized Multi-center Trial of Minimally Invasive Rapid Deployment Versus Conventional Full Sternotomy Aortic Valve Replacement,” Michael A. Borger from the University of Leipzig in Germany along with colleagues randomized 100 patients with aortic stenosis in the CADENCE-MIS trial. Patients underwent either MIS-RDAVR through an upper hemisternotomy (n = 51) or AVR by FS with a conventional stented bioprosthesis (n = 49). After exclusion, 94 patients remained in the trial.
Results showed that between groups, implanted valve sizes were similar. The researchers found an association between MIS-RDAVR and reduced aortic cross-clamp times compared with FS-AVR, although cardiopulmonary bypass times were similar.
Early clinical outcomes were similar between the two groups, including quality of life. The RDAVR patients had a significantly lower mean transvalvular gradient and a lower prevalence of patient–prosthesis mismatch after 3 months postoperatively in comparison to the FS-AVR patients.
Based on the results, the researchers concluded that RDAVR by the MIS method is associated with reduced time of myocardial ischemia and better valvular hemodynamic function in comparison to FS-AVR with a traditional stented bioprosthesis. According to the researchers, rapid deployment valves may facilitate the MIS-AVR performance.