Author + information
- Received May 27, 2018
- Revision received September 30, 2018
- Accepted October 8, 2018
- Published online January 14, 2019.
- Doff B. McElhinney, MDa,∗ (, )@Stanford,
- Jamil A. Aboulhosn, MDb,
- Danny Dvir, MDc,
- Brian Whisenant, MDd,
- Yulin Zhang, PhDa,
- Andreas Eicken, MDe,
- Flavio Ribichini, MDf,
- Aphrodite Tzifa, MDg,
- Michael R. Hainstock, MDh,
- Mary H. Martin, MDi,
- Ran Kornowski, MDj,
- Stephan Schubert, MDk,
- Azeem Latib, MDl,
- John D.R. Thomson, MDm,
- Alejandro J. Torres, MDn,
- Jeffery Meadows, MDo,
- Jeffrey W. Delaney, MDp,
- Mayra E. Guerrero, MDq,
- Stefano Salizzoni, MDr,
- Howaida El-Said, MDs,
- Ariel Finkelstein, MDt,
- Isaac George, MDu,
- Marc Gewillig, MDv,
- Maria Alvarez-Fuente, MDw,
- Luke Lamers, MDx,
- Asim N. Cheema, MDy,
- Jacqueline N. Kreutzer, MDz,
- Tanja Rudolph, MDaa,
- David Hildick-Smith, MDbb,
- Allison K. Cabalka, MDcc,
- for the VIVID Registry
- aStanford University, Palo Alto, California
- bUCLA, Los Angeles, California
- cUniversity of Washington, Seattle, Washington
- dIntermountain Heart Institute, Salt Lake City, Utah
- eGerman Heart Centre Munich, Munich, Germany
- fDivision of Cardiology, Department of Medicine, University of Verona, Verona, Italy
- gMitera Children's Hospital, Athens, Greece
- hUniversity of Virginia, Charlottesville, Virginia
- iPrimary Children's Hospital. Salt Lake City, Utah
- jRabin Medical Center, Petah-Tiqva, Israel
- kGerman Heart Center Berlin, Berlin, Germany
- lSan Raffaele Hospital, Milan, Italy
- mLeeds General Infirmary, Leeds, United Kingdom
- nMorgan Stanley Children's Hospital of New York, New York, New York
- oUniversity of California-San Francisco, San Francisco, California
- pChildren's Hospital and Medical Center, Omaha, Nebraska
- qHenry Ford Hospital, Detroit, Michigan
- rCitta della Salute e della Scienza, Molinette, Torino, Italy
- sUniversity of California San Diego and Rady Childrens Hospital, San Diego, California
- tTel Aviv Medical Center, Tel Aviv, Israel
- uColumbia University, New York, New York
- vUZ Leuven, Leuven, Belgium
- wHospital Ramón y Cajal, Madrid, Spain
- xUniversity of Wisconsin, Madison, Wisconsin
- ySt. Michael's Hospital, Toronto, Ontario, Canada
- zChildren's Hospital of Pittsburgh, Pittsburgh, Pennsylvania
- aaHeart Center at University of Cologne, Cologne, Germany
- bbSussex Cardiac Centre, Brighton and Sussex University Hospitals, United Kingdom
- ccMayo Clinic, Rochester, Minnesota
- ↵∗Address for correspondence:
Dr. Doff B. McElhinney, Department of Cardiothoracic Surgery, Stanford University, 780 Welch Road, Suite CJ110, Palo Alto, California 94304.
Background Transcatheter aortic and pulmonary valves have been used to treat stenosis or regurgitation after prior surgical tricuspid valve (TV) replacement or repair. Little is known about intermediate-term valve-related outcomes after transcatheter tricuspid valve replacement (TTVR), including valve function, thrombus, and endocarditis.
Objectives The authors sought to evaluate mid-term outcomes in a large cohort of patients who underwent TTVR after surgical TV repair or replacement, with a focus on valve-related outcomes.
Methods Patients who underwent TTVR after prior surgical TV replacement or repair were collected through an international registry. Time-related outcomes were modeled and risk factors assessed.
Results Data were collected for 306 patients who underwent TTVR from 2008 through 2017 at 80 centers; 52 patients (17%) had a prior history of endocarditis. Patients were followed for a median of 15.9 months after implantation (0.1 to 90 months), with 64% of patients estimated to be alive without TV reintervention or a valve-related event at 3 years. The cumulative 3-year incidence of death, reintervention, and valve-related adverse outcomes (endocarditis, thrombosis, or significant dysfunction) were 17%, 12%, and 8%, respectively. Endocarditis was diagnosed in 8 patients 2 to 29 months after TTVR, for an annualized incidence rate of 1.5% per patient-year (95% confidence interval: 0.45% to 2.5%). An additional 8 patients were diagnosed with clinically relevant valve thrombosis, 3 in the short term, 2 within 2 months, and 3 beyond 6 months. Only 2 of these 8 patients received anticoagulant therapy before thrombus detection (p = 0.13 vs. patients without thrombus). Prior endocarditis was not a risk factor for reintervention, endocarditis, or valve thrombosis, and there was no difference in valve-related outcomes according to TTVR valve type.
Conclusions TV dysfunction, endocarditis, and leaflet thrombosis were uncommon after TTVR. Patients with prior endocarditis were not at higher risk for endocarditis or other adverse outcomes after TTVR, and endocarditis occurred with similar frequency in different valve types. Though rare, leaflet thrombosis is an important adverse outcome, and further study is necessary to determine the appropriate level of prophylactic therapy after TTVR.
Dr. McElhinney has been a proctor and consultant for Medtronic. Dr. Aboulhosn has been a proctor for Edwards Lifesciences and Medtronic; and has served as site principal investigator for the Compassion S3 trial for Edwards Lifesciences. Dr. Dvir has been a consultant to Edwards Lifesciences and Medtronic. Dr. Whisenant has been a consultant and proctor for Edwards Lifesciences and Boston Scientific. Drs. Eicken and Ribichini have been proctors for Medtronic. Dr. Schubert has been a proctor for Medtronic, Abbott, and Edwards Lifesciences. Dr. Latib has been a proctor/consultant for Medtronic, Abbott Vascular, and Edwards Lifesciences; and has served on an advisory board for Medtronic. Dr. Thomson has been a proctor/consultant for Gore Medical and Abbott Medical. Dr. Torres has been a proctor and consultant for Edwards Lifesciences. Dr. Delaney has been a consultant to Medtronic. Dr. Guerrero has received research support from and been a proctor/consultant to Edwards Lifesciences. Dr. Finkelstein has been a proctor/consultant to Medtronic and Edwards Lifesciences. Dr. George has been a proctor/consultant to Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Gewillig has been a proctor for Edwards Lifesciences and Medtronic. Dr. Kreutzer has been a consultant to Medtronic; and has received research support from Medtronic and Edwards Lifesciences. Dr. Rudolph has been a proctor for and received speakers honoraria from Edwards Lifesciences. Dr. Hildick-Smith has been a proctor and served on advisory boards for Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received May 27, 2018.
- Revision received September 30, 2018.
- Accepted October 8, 2018.
- 2019 American College of Cardiology Foundation
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