eReply. Long-term follow-up data are needed in new valve technologies!

Thanks to Dr Gabay for his response and lively discussion [1]. Let us first set the record straight and agree on the facts: the No-React® Injectable BioPulmonic™ valve was used in our series exactly as we intended, and as was promoted by Biointegral®, using the deployment system provided by Biointegral® according to their recommendations at that time [2]. The off-label use of devices for congenital heart disease is a critical issue, but not uncommon. For example, stenting the pulmonary arteries is still off-label since its introduction more than 20 years ago, but is well-established. Thus, even the current AHA guidelines contain recommendations pointing towards the off-label use of such devices in selected patients [3]. As published, our short-/mid-term results were encouraging, however, our mid-/long-term results were not: our update reported sobering follow-up results with need for revalvulation after a median of 5.7 (range 0.7–7) years. The tilt of the injected valves was a major point of criticism. We assumed that the stiffness of the stent and/or its deployment by injection carried this risk. Moreover, Dr Gabay hypothesized that somatic growth might play a role as well. These mechanisms lead to poor alignment towards the right ventricular outflow tract (RVOT), encouraging turbulent flow pattern as a trigger for neointimal proliferation. However, tilt does not seem to be the only mechanism at play here, as neointimal build-up occurred also with mild tilting (e.g. figure 2, [2]). We acknowledge the Italian group's excellent results [4], but again, as long as only preliminary results are presented, it is not sound (evidence-based) science to conclude that their approach is superior and safe. On the contrary, we would issue a word of caution against implanting relatively rigid, self-expandable and oversized devices, emphasizing the accelerated erosion-risk, as in the ongoing debate about oversized ASD-closure-devices, for example. Nowadays, biological valves should remain effective for at least 8-12 years to qualify as superior, not a median 5-6 years as in our small injectable-valve series. Dr. Gabay assumed that our team missed the “real story”. Perhaps, with all due respect, he overlooked the fact that we treated patients with dilated RV to main pulmonary artery junctions beyond normal diameters due to severe pulmonary insufficiency (e.g. post-transannular tetralogy of Fallot-repair). Thus, oversizing was not required, but valves having a relatively large diameter were. Back then as well as today, large pulmonary valves for minimal-invasive implantation are still not used routinely in dilated native RVOTs [5]. Dr Gabay is right to state that names (e.g. from Shellhigh to No-react), labels (e.g. from FDA-approval to CE-mark) as well as members of a research group can change. However, he obviously failed to notice that two of the original authors are still respected members of our surgical team (Drs Beyersdorf and Siepe) and that the corresponding author was an enthusiastic participant during several implantations, whereas Dr Gabay was almost always present as a consultant/proctor. Our article was written by the key members of our heart team, and represents the opinion of both surgeons and cardiologists at our Heart Centre. Conflict of interest: none declared.