Doff B McElhinney1, Allison K Cabalka2, Jamil A Aboulhosn2, Andreas Eicken2, Younes Boudjemline2, Stephan Schubert2, Dominique Himbert2, Jeremy D Asnes2, Stefano Salizzoni2, Martin L Bocks2, John P Cheatham2, Tarek S Momenah2, Dennis W Kim2, Dietmar Schranz2, Jeffery Meadows2, John D R Thomson2, Bryan H Goldstein2, Ivory Crittendon2, Thomas E Fagan2, John G Webb2, Eric Horlick2, Jeffrey W Delaney2, Thomas K Jones2, Shabana Shahanavaz2, Carolina Moretti2, Michael R Hainstock2, Damien P Kenny2, Felix Berger2, Charanjit S Rihal2, Danny Dvir2. 1. From Stanford University, Palo Alto, CA (D.B.M.); Mayo Clinic, Rochester, MN (A.K.C., C.J.R.); University of California Los Angeles (J.A.A.); German Heart Centre, Munich, Germany (A.E.); Necker Enfants Malades Hospital, Paris, France (Y.B.); Deutsches Herzzentrum Berlin, Germany (S. Schubert, B.G.); Bichat Hospital, Paris, France (D.H.); Yale University, New Haven, CT (J.D.A.); Città della Salute e della Scienza, Molinette, Torino, Italy (S. Salizzoni); University of Michigan, Ann Arbor (M.L.B.); Nationwide Children's Hospital, Columbus, OH (J.P.C.); Prince Sultan Cardiac Center, Riyadh, Saudi Arabia (T.S.M.); Emory University, Atlanta, GA (D.W.K.); University Hospital of Giessen, Giessen, Germany (D.S.); University of California San Francisco, San Francisco (J.M.); Leeds General Infirmary, Leeds, UK (J.D.R.T.); Cincinnati Children's Hospital Medical Center, Cincinnati, OH (B.H.G.); Ochsner Hospital for Children, New Orleans, LA (J.C.); Children's Hospital Colorado, Aurora (T.E.F.); St. Paul's Hospital, Vancouver, CA (J.G.W., D.D.); Toronto General Hospital, ON, Canada (E.H.); Children's Hospital and Medical Center, Omaha, NE (J.W.D.); Seattle Children's Hospital, Seattle, WA (T.K.J.); St. Louis Children's Hospital, MO (S. Shahanavaz); S. Orsola-Malpighi Hospital, Bologna, Italy (C.M.); University of Virginia, Charlottesville (M.R.H.); and Rush University Medical Center, Chicago, IL (D.P.K.). doff@stanford.edu. 2. From Stanford University, Palo Alto, CA (D.B.M.); Mayo Clinic, Rochester, MN (A.K.C., C.J.R.); University of California Los Angeles (J.A.A.); German Heart Centre, Munich, Germany (A.E.); Necker Enfants Malades Hospital, Paris, France (Y.B.); Deutsches Herzzentrum Berlin, Germany (S. Schubert, B.G.); Bichat Hospital, Paris, France (D.H.); Yale University, New Haven, CT (J.D.A.); Città della Salute e della Scienza, Molinette, Torino, Italy (S. Salizzoni); University of Michigan, Ann Arbor (M.L.B.); Nationwide Children's Hospital, Columbus, OH (J.P.C.); Prince Sultan Cardiac Center, Riyadh, Saudi Arabia (T.S.M.); Emory University, Atlanta, GA (D.W.K.); University Hospital of Giessen, Giessen, Germany (D.S.); University of California San Francisco, San Francisco (J.M.); Leeds General Infirmary, Leeds, UK (J.D.R.T.); Cincinnati Children's Hospital Medical Center, Cincinnati, OH (B.H.G.); Ochsner Hospital for Children, New Orleans, LA (J.C.); Children's Hospital Colorado, Aurora (T.E.F.); St. Paul's Hospital, Vancouver, CA (J.G.W., D.D.); Toronto General Hospital, ON, Canada (E.H.); Children's Hospital and Medical Center, Omaha, NE (J.W.D.); Seattle Children's Hospital, Seattle, WA (T.K.J.); St. Louis Children's Hospital, MO (S. Shahanavaz); S. Orsola-Malpighi Hospital, Bologna, Italy (C.M.); University of Virginia, Charlottesville (M.R.H.); and Rush University Medical Center, Chicago, IL (D.P.K.).
Abstract
BACKGROUND: Off-label use of transcatheter aortic and pulmonary valve prostheses for tricuspid valve-in-valve implantation (TVIV) within dysfunctional surgical tricuspid valve (TV) bioprostheses has been described in small reports. METHODS AND RESULTS: An international, multicenter registry was developed to collect data on TVIV cases. Patient-related factors, procedural details and outcomes, and follow-up data were analyzed. Valve-in-ring or heterotopic TV implantation procedures were not included. Data were collected on 156 patients with bioprosthetic TV dysfunction who underwent catheterization with planned TVIV. The median age was 40 years, and 71% of patients were in New York Heart Association class III or IV. Among 152 patients in whom TVIV was attempted with a Melody (n=94) or Sapien (n=58) valve, implantation was successful in 150, with few serious complications. After TVIV, both the TV inflow gradient and tricuspid regurgitation grade improved significantly. During follow-up (median, 13.3 months), 22 patients died, 5 within 30 days; all 22 patients were in New York Heart Association class III or IV, and 9 were hospitalized before TVIV. There were 10 TV reinterventions, and 3 other patients had significant recurrent TV dysfunction. At follow-up, 77% of patients were in New York Heart Association class I or II (P<0.001 versus before TVIV). Outcomes did not differ according to surgical valve size or TVIV valve type. CONCLUSIONS: TVIV with commercially available transcatheter prostheses is technically and clinically successful in patients of various ages across a wide range of valve size. Although preimplantation clinical status was associated with outcome, many patients in New York Heart Association class III or IV at baseline improved. TVIV should be considered a viable option for treatment of failing TV bioprostheses.
BACKGROUND: Off-label use of transcatheter aortic and pulmonary valve prostheses for tricuspid valve-in-valve implantation (TVIV) within dysfunctional surgical tricuspid valve (TV) bioprostheses has been described in small reports. METHODS AND RESULTS: An international, multicenter registry was developed to collect data on TVIV cases. Patient-related factors, procedural details and outcomes, and follow-up data were analyzed. Valve-in-ring or heterotopic TV implantation procedures were not included. Data were collected on 156 patients with bioprosthetic TV dysfunction who underwent catheterization with planned TVIV. The median age was 40 years, and 71% of patients were in New York Heart Association class III or IV. Among 152 patients in whom TVIV was attempted with a Melody (n=94) or Sapien (n=58) valve, implantation was successful in 150, with few serious complications. After TVIV, both the TV inflow gradient and tricuspid regurgitation grade improved significantly. During follow-up (median, 13.3 months), 22 patients died, 5 within 30 days; all 22 patients were in New York Heart Association class III or IV, and 9 were hospitalized before TVIV. There were 10 TV reinterventions, and 3 other patients had significant recurrent TV dysfunction. At follow-up, 77% of patients were in New York Heart Association class I or II (P<0.001 versus before TVIV). Outcomes did not differ according to surgical valve size or TVIV valve type. CONCLUSIONS:TVIV with commercially available transcatheter prostheses is technically and clinically successful in patients of various ages across a wide range of valve size. Although preimplantation clinical status was associated with outcome, many patients in New York Heart Association class III or IV at baseline improved. TVIV should be considered a viable option for treatment of failing TV bioprostheses.