Author + information
- David W.M. Muller, MBBS, MD∗ (, )
- Tendyne Global Feasibility Trial Investigators
- ↵∗Cardiology Department, St. Vincent’s Hospital, Victoria Street, Darlinghurst, New South Wales 2010, Australia
The authors thank Dr. Rasla and colleagues for their interest in our feasibility study (1). We agree that it is not possible to generalize the results of this consecutive series to the larger population of patients with mitral regurgitation. The patients treated were indeed carefully selected and the study was unblinded as would be expected in a first-in-human feasibility trial. The limited number of women and patients with degenerative mitral regurgitation included in the study cohort is likely to reflect the exclusion of patients with small left ventricular dimensions and the potential for left ventricular outflow obstruction after this intervention. The inclusion of 3 patients with a left ventricular ejection fraction <30% was addressed in a recently published correction to the Methods section of the paper (1). These patients met the inclusion criteria (left ventricular ejection fraction >30%) at the time of their enrolment, but the left ventricular ejection fraction had fallen to <30% at the time of the intervention.
Finally, we agree that, as stated in the manuscript, broad application of this technology will require pivotal comparative trials to better define the role of the intervention in the management of patients with severe symptomatic mitral regurgitation. Ongoing observational registries will provide additional data to help design these trials.
Please note: Dr. Muller is an advisory board member and consultant to Medtronic, Boston Scientific, and Edwards Lifesciences; has received research grant support from Tendyne, Abbott Vascular, and Medtronic; and is a proctor for Medtronic and Abbott Vascular.
- 2017 American College of Cardiology Foundation