Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves: An International, Multicenter Registry Study

Doff B. McElhinney, Allison K. Cabalka, Jamil A. Aboulhosn, Andreas Eicken, Younes Boudjemline, Stephan Schubert, Dominique Himbert, Jeremy D. Asnes, Stefano Salizzoni, Martin L. Bocks, John P. Cheatham, Tarek S. Momenah, Dennis W. Kim, Dietmar Schranz, Jeffery Meadows, John D R Thomson, Bryan H. Goldstein, Ivory Crittendon, Thomas E. Fagan, John G. WebbEric Horlick, Jeffrey W Delaney, Thomas K. Jones, Shabana Shahanavaz, Carolina Moretti, Michael R. Hainstock, Damien P. Kenny, Felix Berger, Charanjit S. Rihal, Danny Dvir

Research output: Contribution to journalArticle

80 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1582-1593
Number of pages12
JournalCirculation
Volume133
Issue number16
DOIs
StatePublished - Apr 19 2016

Fingerprint

Tricuspid Valve
Surgical Instruments
Multicenter Studies
Registries
Therapeutics
Bioprosthesis
Prostheses and Implants
Off-Label Use
Pulmonary Valve
Tricuspid Valve Insufficiency

Keywords

  • Ebstein anomaly
  • endocarditis
  • heart valves
  • rheumatic heart disease
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves : An International, Multicenter Registry Study. / McElhinney, Doff B.; Cabalka, Allison K.; Aboulhosn, Jamil A.; Eicken, Andreas; Boudjemline, Younes; Schubert, Stephan; Himbert, Dominique; Asnes, Jeremy D.; Salizzoni, Stefano; Bocks, Martin L.; Cheatham, John P.; Momenah, Tarek S.; Kim, Dennis W.; Schranz, Dietmar; Meadows, Jeffery; Thomson, John D R; Goldstein, Bryan H.; Crittendon, Ivory; Fagan, Thomas E.; Webb, John G.; Horlick, Eric; Delaney, Jeffrey W; Jones, Thomas K.; Shahanavaz, Shabana; Moretti, Carolina; Hainstock, Michael R.; Kenny, Damien P.; Berger, Felix; Rihal, Charanjit S.; Dvir, Danny.

In: Circulation, Vol. 133, No. 16, 19.04.2016, p. 1582-1593.

Research output: Contribution to journalArticle

McElhinney, DB, Cabalka, AK, Aboulhosn, JA, Eicken, A, Boudjemline, Y, Schubert, S, Himbert, D, Asnes, JD, Salizzoni, S, Bocks, ML, Cheatham, JP, Momenah, TS, Kim, DW, Schranz, D, Meadows, J, Thomson, JDR, Goldstein, BH, Crittendon, I, Fagan, TE, Webb, JG, Horlick, E, Delaney, JW, Jones, TK, Shahanavaz, S, Moretti, C, Hainstock, MR, Kenny, DP, Berger, F, Rihal, CS & Dvir, D 2016, 'Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves: An International, Multicenter Registry Study', Circulation, vol. 133, no. 16, pp. 1582-1593. https://doi.org/10.1161/CIRCULATIONAHA.115.019353
McElhinney, Doff B. ; Cabalka, Allison K. ; Aboulhosn, Jamil A. ; Eicken, Andreas ; Boudjemline, Younes ; Schubert, Stephan ; Himbert, Dominique ; Asnes, Jeremy D. ; Salizzoni, Stefano ; Bocks, Martin L. ; Cheatham, John P. ; Momenah, Tarek S. ; Kim, Dennis W. ; Schranz, Dietmar ; Meadows, Jeffery ; Thomson, John D R ; Goldstein, Bryan H. ; Crittendon, Ivory ; Fagan, Thomas E. ; Webb, John G. ; Horlick, Eric ; Delaney, Jeffrey W ; Jones, Thomas K. ; Shahanavaz, Shabana ; Moretti, Carolina ; Hainstock, Michael R. ; Kenny, Damien P. ; Berger, Felix ; Rihal, Charanjit S. ; Dvir, Danny. / Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves : An International, Multicenter Registry Study. In: Circulation. 2016 ; Vol. 133, No. 16. pp. 1582-1593.
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abstract = "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.",
keywords = "Ebstein anomaly, endocarditis, heart valves, rheumatic heart disease, transcatheter aortic valve replacement",
author = "McElhinney, {Doff B.} and Cabalka, {Allison K.} and Aboulhosn, {Jamil A.} and Andreas Eicken and Younes Boudjemline and Stephan Schubert and Dominique Himbert and Asnes, {Jeremy D.} and Stefano Salizzoni and Bocks, {Martin L.} and Cheatham, {John P.} and Momenah, {Tarek S.} and Kim, {Dennis W.} and Dietmar Schranz and Jeffery Meadows and Thomson, {John D R} and Goldstein, {Bryan H.} and Ivory Crittendon and Fagan, {Thomas E.} and Webb, {John G.} and Eric Horlick and Delaney, {Jeffrey W} and Jones, {Thomas K.} and Shabana Shahanavaz and Carolina Moretti and Hainstock, {Michael R.} and Kenny, {Damien P.} and Felix Berger and Rihal, {Charanjit S.} and Danny Dvir",
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T1 - Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves

T2 - An International, Multicenter Registry Study

AU - McElhinney, Doff B.

AU - Cabalka, Allison K.

AU - Aboulhosn, Jamil A.

AU - Eicken, Andreas

AU - Boudjemline, Younes

AU - Schubert, Stephan

AU - Himbert, Dominique

AU - Asnes, Jeremy D.

AU - Salizzoni, Stefano

AU - Bocks, Martin L.

AU - Cheatham, John P.

AU - Momenah, Tarek S.

AU - Kim, Dennis W.

AU - Schranz, Dietmar

AU - Meadows, Jeffery

AU - Thomson, John D R

AU - Goldstein, Bryan H.

AU - Crittendon, Ivory

AU - Fagan, Thomas E.

AU - Webb, John G.

AU - Horlick, Eric

AU - Delaney, Jeffrey W

AU - Jones, Thomas K.

AU - Shahanavaz, Shabana

AU - Moretti, Carolina

AU - Hainstock, Michael R.

AU - Kenny, Damien P.

AU - Berger, Felix

AU - Rihal, Charanjit S.

AU - Dvir, Danny

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N2 - 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.

AB - 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.

KW - Ebstein anomaly

KW - endocarditis

KW - heart valves

KW - rheumatic heart disease

KW - transcatheter aortic valve replacement

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