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Rebuttal to the Letter to the Editor entitled "Please not again: recommendations after five negative cases!"

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We are pleased that our short article highlighting concerns over Sinus-SuperFlex-DS stent deformation occurring after deployment in the patent ductus as part of the Hybrid procedure has attracted controversy. Professor… Click to show full abstract

We are pleased that our short article highlighting concerns over Sinus-SuperFlex-DS stent deformation occurring after deployment in the patent ductus as part of the Hybrid procedure has attracted controversy. Professor Schranz is correct to point out that the hybrid procedure is used by a handful of institutions around the world as first line therapy for hypoplastic left heart syndrome (HLHS) but most institutions have not followed this route reserving the hybrid procedure for cases too unwell to undergo a primary Norwood or abandoning the hybrid procedure altogether. We recently conducted an analysis of the Hybrid procedure undertaken in at risk infants in four centers across the UK and compared this with outcomes for those infants undergoing primary Norwood. Interestingly, we found that survival was not different despite there being marked differences in the two groups at baseline. We therefore agree with the author that Hybrid continues to have an important place in the management of HLHS, at least in the very sickest of infants. We read with interest Professor Schranz's comments in which he points out that, rather than being novel our case series simply adds to the growing evidence of stent compression following the use of the Sinus super-flex ductal stent. Far from offering guidelines for practice, we simply intended to highlight to readers of the journal one of the potential complications that can occur, when stenting the duct using the only specifically CE marked device. Any complication profile has, of course to be weighed up against the advantages of a piece of equipment and in the case of the superflex stent there are many-in particular its ease of use and low delivery profile. Interventionists are well adept at balancing advantages and disadvantages of equipment if they are aware of them. Very few implanting centers can rival Giessen for length and breadth of experience in ductal stenting. We are therefore surprised that Professor Schranz takes issue with our advice to keep these stents under close scrutiny. It would seem very prudent, if not essential, for units performing Hybrid to adopt careful echocardiographic screening protocols that monitor for signs of such an eventuality. This we have done and we stand by reporting it to the wider interventional community for their benefit. There is insufficient information in such a brief report to make critical comments about duct morphology, stent position, and stent choice and we will not endeavor to respond to these remarks. The true measure of any piece of equipment or indeed procedure is not necessarily performance in the hands of the highest volume “experts” but how it translates to the “everyday” and in this regard whilst we accept some of the criticisms of our “imperfect” practice the truth is this is real world use of the stent, within a large volume program in the only environment the stent was intended for. We do not believe that a structural issue of this sort can be fully ameliorated by the steps Professor Schranz offers such as an altered prostaglandin strategy or the use of one cyclooxygenase inhibitor or another. As a final comment, as all experienced interventionalists know, there can never be a completely “right way” to do any procedure, and whilst we have all learned enormously from the eponymous “Giessen” or “Columbus” approaches, the vulnerable neonate with an arterial duct dependent circulation remains an extreme challenge and one for which we hope that technical lessons will continue to be learned and shared (no matter how apparently foolish) amongst colleagues long after the baton has been handed on to future generations.

Keywords: hybrid procedure; procedure; rebuttal letter; professor schranz; stent; letter editor

Journal Title: Catheterization and Cardiovascular Interventions
Year Published: 2021

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