title: Prospective study of tricuspid valve regurgitation associated with permanent leads in patients undergoing cardiac rhythm device implantation: Background, rationale, and design.
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.
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Hisham
authors.initials: H
authors.lastname: Dokainish
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Esam
authors.initials: E
authors.lastname: Elbarasi
authors.affiliation: Universita' Politacnica delle Marche, Ancona, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Masiero
authors.affiliation: Antwerp University Hospital, Antwerp, Belgium.
authors.forename: Caroline
authors.initials: C
authors.lastname: Van de Heyning
authors.affiliation: Universita' Politacnica delle Marche, Ancona, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Brambatti
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Sami
authors.initials: S
authors.lastname: Ghazal
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Said
authors.initials: S
authors.lastname: Al-Maashani
authors.affiliation: Universita' Politacnica delle Marche, Ancona, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Capucci
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Lisanne
authors.initials: L
authors.lastname: Buikema
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Darryl
authors.initials: D
authors.lastname: Leong
authors.affiliation: Antwerp University Hospital, Antwerp, Belgium.
authors.forename: Bharati
authors.initials: B
authors.lastname: Shivalkar
authors.affiliation: Antwerp University Hospital, Antwerp, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: Saenen
authors.affiliation: Antwerp University Hospital, Antwerp, Belgium.
authors.forename: Hielko
authors.initials: H
authors.lastname: Miljoen
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Carlos
authors.initials: C
authors.lastname: Morillo
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Syam
authors.initials: S
authors.lastname: Divarakarmenon
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Guy
authors.initials: G
authors.lastname: Amit
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Ribas
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Aaron
authors.initials: A
authors.lastname: Brautigam
authors.affiliation: Universita' Politacnica delle Marche, Ancona, Italy.
authors.forename: Erika
authors.initials: E
authors.lastname: Baiocco
authors.affiliation: Universita' Politacnica delle Marche, Ancona, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Maolo
authors.affiliation: Universita' Politacnica delle Marche, Ancona, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Romandini
authors.affiliation: Universita' Politacnica delle Marche, Ancona, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Maffei
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Stuart
authors.initials: S
authors.lastname: Connolly
authors.affiliation: McMaster University, Hamilton, ON, Canada.
authors.forename: Jeff
authors.initials: J
authors.lastname: Healey