. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Perspective on the treatment of functional mitral regurgitation using the Cardioband System David Messika-Zeitoun 1 *, Alec Vahanian 2 , Patrick Verta 3 , and Francesco Maisano 4 1 University of Ottawa Heart Institute, Ottawa, Canada; 2 Department of Cardiology, Assistance Publique–Ho ˆ pitaux de Paris (AP-HP), Bichat Hospital, Paris, France; 3 Edwards Lifesciences, Irvine, California, USA; and 4 University Heart Center, University Hospital Zu ¨rich, Zu ¨rich, Switzerland Online publish-ahead-of-print 9 September 2019 This commentary refers to ‘Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes’, by D. Messika- Zeitoun et al., 2019;40:466–472. We read with interest Dr Shapira’s editorial regarding our manu- script entitled ‘Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes’. 1 The comment that ‘these rather optimistic results are obviously misleading’ contradicts the transparency evidenced by the detailed data and discussion provided in the manuscript. We presented data both as paired comparisons and in the overall population taking into account loss to follow-up, deaths, and reintervention, approach un- common in the medical literature. The comment ‘Cardioband system is far from being perfect’ mis- construes our intent for reporting early results of an innovative ther- apy (first 60 patients implanted since the first-in-human experience in 2013) that encompass a mix of learning curve and technical improve- ments, including anchor disengagements which were concentrated in the first half of our experience. To view these results as the final po- tential of the device, and to compare these preliminary results to those obtained in surgery in different populations, is inaccurate. As with any novel procedure, improvements in both procedural length and success rates are expected as teams gain experience. Assessment of MR severity is questioned. Like all transcatheter/ surgical therapies, this procedure is performed under general anaes- thesia which is known to affect MR severity. Haemodynamic stimula- tion could easily be implemented in the future. More importantly, the degree of MR was re-evaluated before discharge using transthoracic echocardiography. The criticism that the implant is ‘not a full ring’ and that ‘the more stringent mitral valve academic research consortium definition of “optimal” residual MR should have been considered and would have yielded results inferior to those achievable by a surgical undersized ring implantation’ should be addressed. Comparing studies is difficult at best; however, if one wish to do so, assessment of surgical out- comes should come from one of the few randomized studies 2 which reported a 32.6% rate of moderate or severe—not mild—MR recur- rence at 1 year, with a complete ring. The opinion that the Cardioband is equivalent to surgical examples of ‘not a full ring’ is based on historical preconceptions and the assumption that all things are equal between transcatheter and surgical therapies other than ac- cess. The capability to perform real-time echo assessment and size adjustment on a beating heart is unique compared to the need to de- fine a leaflet coaptation criteria during surgical intervention in arrested heart context. The suggestion that we treated patients that should not have been treated citing the current ESC/EACTS guidelines is incorrect. 3 Level of evidence is weak, and management of these patients still debated. 4 Finally, it is stated that the device is “not suitable for a considerable number of patients” citing a reference reporting 11.7% prevalence of mitral annular calcification in patients with MR’. Not all valve anatomies are suitable for the Cardioband device and patients with MAC or ex- treme tethering were excluded as mentioned in our manuscript. In our experience, the Cardioband system is applicable in a fair propor- tion of functional MR patients. We do hope that our response will help the reader having a better understanding of current achievements and prospects of the Cardioband system. Conflict of interest: D.M.-Z. is a consultant for Edwards Lifesciences, Mardil and Cardiawave and receives research grants from Edwards Lifesciences and Abbott vascular. A.V. is consultant for Edwards Lifesciences, Abbott vascular and Mitraltech. P.V. is an Edwards Lifesciences employee. F.M. is consultant Edwards * Corresponding author. Tel: 613 696 7337, Fax: 613 696 7127, Email: dmessika-zeitoun@ottawaheart.ca The authors of ehz613 were invited to submit a response to Discussion Forum contribution ehy424, but opted not to. Published on behalf of the European Society of Cardiology. All rights reserved. V C The Author(s) 2019. For permissions, please email: journals.permissions@oup.com. European Heart Journal (2019) 40, 3196–3197 DISCUSSION FORUM doi:10.1093/eurheartj/ehz613 Downloaded from https://academic.oup.com/eurheartj/article/40/38/3196/5566426 by guest on 28 October 2022