Prospective study of tricuspid valve regurgitation associated with permanent leads in patients undergoing cardiac rhythm device implantation: Background, rationale, and design

Hisham Dokainish, Esam Elbarasi, Simona Masiero, Caroline Van de Heyning, Michela Brambatti, Sami Ghazal, Said AL-Maashani, Alessandro Capucci, Lisanne Buikema, Darryl Leong, Bharati Shivalkar, Johan Saenen, Hielko Miljoen, Carlos Morillo, Syam Divarakarmenon, Guy Amit, Sebastien Ribas, Aaron Brautigam, Erika Baiocco, Alessandro Maolo, Andrea Romandini, Simone Maffei, Stuart Connolly, Jeff Healey

Abstract


Given the increasing numbers of cardiac device implantations worldwide, it is important to determine whether permanent endocardial leads across the tricuspid valve can promote tricuspid regurgitation (TR). Virtually all current data is retrospective, and indicates a signal of TR being increased after permanent lead implantation. However, the precise incidence of moderate or greater TR post-procedure, the exact mechanisms (mechanical, traumatic, functional), and the hemodynamic burden and clinical effects of this putative increase in TR, remain uncertain. We have therefore designed a multicenter, international, prospective study of 300 consecutive patients (recruitment completed, baseline data presented) who will undergo echocardiography and clinical assessment prior to, and at 1-year post device insertion. This prospective study will help determine whether cardiac device-associated TR is real, what are its potential mechanisms, and whether it has an important clinical impact on cardiac device patients.

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Copyright (c) 2017 Hisham Dokainish, Esam Elbarasi, Simona Masiero, Caroline Van de Heyning, Michela Brambatti, Sami Ghazal, Said AL-Maashani, Alessandro Capucci, Lisanne Buikema, Darryl Leong, Bharati Shivalkar, Johan Saenen, Hielko Miljoen, Carlos Morillo, Syam Divarakarmenon, Guy Amit, Sebastien Ribas, Aaron Brautigam, Erika Baiocco, Alessandro Maolo, Andrea Romandini, Simone Maffei, Stuart Connolly, Jeff Healey

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