Rapid Deployment But Not Hasty Conclusions

We read Ensminger’s article [1] comparing outcomes of rapid deployment (RDVs) vs. conventional biological valves (CBVs). However, we feel to express some criticism as they stand in contrast to our experience [2] in this field. Firstly, we would like to criticize nonconforming errors (Table 1) of sensitive parameters, which lead to confusion, and, if proven true, need recalculation. A potential flaw of pressure gradients analysis is the fact that the comparison is based on labeled sizes and not on patients’ annular dimension after decalcification. Since RDVs are intra-annular devices and CBVs are mainly implanted supra-annularly, the only way to compare hemodynamic data is to group patients by their annular size (e.g.: Perceval size “S” covers annular sizes from 19 mm to 21 mm, is therefore comparable to a 19 mm Intuity, which was omitted from the analysis). Therefore, hemodynamic measurements are not valid and potentially “comparing apples and oranges”. Furthermore, body surface area was not used as a variable for the propensity score matching. No information exists about the incidence of prosthesis-patient mismatch. Higher postoperative gradients and greater incidence of stroke for “sutureless” as compared to “balloon expandable” were observed only in the isolated AVR group and not in the combined CABG+AVR group. Theoretically, gradients should not be influenced by adding bypass grafts, and with regard to stroke, it would be logical to expect an increased risk due to aortic manipulation on the ascending aorta and longer ECC times. Faced with this counter-intuitive evidences we would have liked possible explanations from the authors. Moreover, 10% of patients in the RDV group received a valve that was withdrawn from the market for inferior functional performance, but influences results significantly. The only homogeneous results in isolated and combined groups is the need for new pacemaker implantation. We are skeptical that any conclusions can be made without analyzing risk factors for this outcome (e.g. preoperative right bundle-branch block). PERSIST, the ongoing prospective randomized trial comparing sutureless and CBVs (NCT02673697) will help us shed more light onto these issues.