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Ann Cardiothorac Surg. 2015 Mar;4(2):131-9. doi: 10.3978/j.issn.2225-319X.2015.02.05.

Sutureless Aortic Valve Replacement International Registry (SU-AVR-IR): design and rationale from the International Valvular Surgery Study Group (IVSSG).

Annals of cardiothoracic surgery

Marco Di Eusanio, Kevin Phan, Denis Bouchard, Thierry P Carrel, Otto E Dapunt, Roberto Di Bartolomeo, Harald C Eichstaedt, Theodor Fischlein, Thierry Folliguet, Borut Gersak, Mattia Glauber, Axel Haverich, Martin Misfeld, Peter J Oberwalder, Giuseppe Santarpino, Malakh Lal Shrestha, Marco Solinas, Marco Vola, Francesco Alamanni, Alberto Albertini, Gopal Bhatnagar, Michel Carrier, Stephen Clark, Federic Collart, Utz Kappert, Alfred Kocher, Bart Meuris, Carmelo Mignosa, Ahmed Ouda, Marc Pelletier, Parwis Baradaran Rahmanian, David Reineke, Kevin Teoh, Giovanni Troise, Emmanuel Villa, Thorsten Wahlers, Tristan D Yan

Affiliations

  1. 1 Cardiac Surgery Department, Sant'Orsola Malpighi Hospital, University of Bologna, Italy ; 2 The Collaborative Research (CORE) Group, Macquarie University, Sydney, Australia ; 3 Montreal Heart Institute, Montréal, Canada ; 4 Hopital Universitaire de Berne, Berne, Switzerland ; 5 University Hospital Graz, Graz, Austria ; 6 European Medical School Oldenburg-Groningen, Klinikum Oldenburg, Germany ; 7 Cardiovascular Center, Paracelsus Medical University, Nuremberg, Germany ; 8 Centre Hospitalier Universitaire de Nancy, Université de Lorraine, Nancy, France ; 9 University Medical Center Ljubljana, Ljubljana, Slovenia ; 10 Istituto Clinico Sant'Ambrogio, Clinical & Research Hospitals IRCCS Gruppo San Donato, Milan, Italy ; 11 Hannover Medical School, Hannover, Germany ; 12 University of Leipzig, Leipzig, Germany ; 13 Pasquinucci Heart Hospital, Massa, Italy ; 14 Cardiovascular Surgery Unit, St-Etienne University Hospital; 15 Milan Institute, Monzino, Italy ; 16 Salus Hospital, GVM Care & Research, Reggio Emilia, Italy ; 17 Trillium Health Center, Mississauga, Canada ; 18 Freeman Hospital, Cardiothoracic Centre, Newcastle, UK ; 19 Hopital de la Timone, Marsielle, France ; 20 Dresden Heart Center, Department of cardiac surgery, Dresden University Hospital, Dresden, Germany ; 21 Medical University Vienna, Vienna, Austria ; 22 Gasthuisberg, Cardiale Heelkunde, Leuven, Belgium ; 23 Ferrarotto Hospital, University of Catania, Catania, Italy ; 24 New Brunswick Heart Centre, Saint John, Canada ; 25 University Hospital Cologne, Cologne, Germany ; 26 Southlake Regional Health Centre, Ontario, Canada ; 27 Poliambulanza Foundation Hospital, Brescia, Italy.

PMID: 25870808 PMCID: PMC4384261 DOI: 10.3978/j.issn.2225-319X.2015.02.05

Abstract

BACKGROUND: Sutureless aortic valve replacement (SU-AVR) is an innovative approach which shortens cardiopulmonary bypass and cross-clamp durations and may facilitate minimally invasive approach. Evidence outlining its safety, efficacy, hemodynamic profile and potential complications is replete with small-volume observational studies and few comparative publications.

METHODS: Minimally invasive aortic valve surgery and high-volume SU-AVR replacement centers were contacted for recruitment into a global collaborative coalition dedicated to sutureless valve research. A Research Steering Committee was formulated to direct research and support the mission of providing registry evidence warranted for SU-AVR.

RESULTS: The International Valvular Surgery Study Group (IVSSG) was formed under the auspices of the Research Steering Committee, comprised of 36 expert valvular surgeons from 27 major centers across the globe. IVSSG Sutureless Projects currently proceeding include the Retrospective and Prospective Phases of the SU-AVR International Registry (SU-AVR-IR).

CONCLUSIONS: The global pooling of data by the IVSSG Sutureless Projects will provide required robust clinical evidence on the safety, efficacy and hemodynamic outcomes of SU-AVR.

Keywords: Sutureless; aortic valve replacement (AVR); collaborative research; prospective registry; rapid deployment; retrospective registry; the International Valvular Surgery Study Group (IVSSG)

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