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Expansion of the indication of transcatheter aortic valve implantation--feasibility and outcome in "off-label" patients compared with "on-label" patients

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Expansion of the indication of transcatheter aortic valve implantation--feasibility and outcome in "off-label" patients compared with "on-label" patients. / Frerker, Christian; Schewel, Jury; Schewel, Dimitry; Wohlmuth, Peter; Schmidt, Tobias; Kreidel, Felix; Bader, Ralf; Kuck, Karl-Heinz; Schäfer, Ulrich.

In: J INVASIVE CARDIOL, Vol. 27, No. 5, 05.2015, p. 229-236.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Frerker, C, Schewel, J, Schewel, D, Wohlmuth, P, Schmidt, T, Kreidel, F, Bader, R, Kuck, K-H & Schäfer, U 2015, 'Expansion of the indication of transcatheter aortic valve implantation--feasibility and outcome in "off-label" patients compared with "on-label" patients', J INVASIVE CARDIOL, vol. 27, no. 5, pp. 229-236.

APA

Frerker, C., Schewel, J., Schewel, D., Wohlmuth, P., Schmidt, T., Kreidel, F., Bader, R., Kuck, K-H., & Schäfer, U. (2015). Expansion of the indication of transcatheter aortic valve implantation--feasibility and outcome in "off-label" patients compared with "on-label" patients. J INVASIVE CARDIOL, 27(5), 229-236.

Vancouver

Frerker C, Schewel J, Schewel D, Wohlmuth P, Schmidt T, Kreidel F et al. Expansion of the indication of transcatheter aortic valve implantation--feasibility and outcome in "off-label" patients compared with "on-label" patients. J INVASIVE CARDIOL. 2015 May;27(5):229-236.

Bibtex

@article{9a91ab015a1b4beb9401721e915dd3ab,
title = "Expansion of the indication of transcatheter aortic valve implantation--feasibility and outcome in {"}off-label{"} patients compared with {"}on-label{"} patients",
abstract = "BACKGROUND: We compare the feasibility and outcomes of {"}off-label{"} transcatheter aortic valve implantation (TAVI) patients with a standard {"}on-label{"} TAVI population.METHODS: A total of 591 high-risk patients (pts) underwent a TAVI procedure at our institution. Of these, 435 pts (73.6%) were treated for an on-label indication (group A) and 156 pts (26.4%) were treated for an off-label indication (group B). Group B was further subdivided into patients with pure aortic regurgitation (n = 22; group B.1), anatomical considerations (n = 26; group B.2), very low ejection fraction ≤20% (n = 12; group B.3), concomitant severe mitral regurgitation >2+ (n = 44; group B.4), degenerated aortic bioprosthesis (n = 30; group B.5), and hemodynamic instability with the need for cardiopulmonary bypass (n = 22; group B.6). Outcome parameters were classified according to the Valve Academic Research Consortium-2 criteria.RESULTS: The mean log EuroSCORE of the entire study group was 25 ± 16% (33 ± 21% in group B vs 22 ± 14% in group A; P<.001). Overall device success was 90% (91.3% in group A vs 86.5% in group B; P=.02). Overall 30-day mortality was 9.7%. Group B had a higher 30-day mortality compared with group A (14.7% vs 7.8%, respectively; P=.01). Group B.5 had the lowest 30-day mortality (3.3%).CONCLUSION: Corresponding to the higher surgical risk of group B, 30-day mortality was higher for off-label pts. Patients treated as valve-in-valve had the lowest 30-day mortality, emphasizing its great potential as opposed to redo open-heart surgery.",
keywords = "Aged, 80 and over, Aortic Valve/surgery, Aortic Valve Stenosis/diagnosis, Bioprosthesis, Feasibility Studies, Female, Follow-Up Studies, Heart Valve Prosthesis, Humans, Male, Patient Selection, Prosthesis Design, Retrospective Studies, Risk Factors, Transcatheter Aortic Valve Replacement/methods, Treatment Outcome",
author = "Christian Frerker and Jury Schewel and Dimitry Schewel and Peter Wohlmuth and Tobias Schmidt and Felix Kreidel and Ralf Bader and Karl-Heinz Kuck and Ulrich Sch{\"a}fer",
year = "2015",
month = may,
language = "English",
volume = "27",
pages = "229--236",
journal = "J INVASIVE CARDIOL",
issn = "1042-3931",
publisher = "HMP Communications",
number = "5",

}

RIS

TY - JOUR

T1 - Expansion of the indication of transcatheter aortic valve implantation--feasibility and outcome in "off-label" patients compared with "on-label" patients

AU - Frerker, Christian

AU - Schewel, Jury

AU - Schewel, Dimitry

AU - Wohlmuth, Peter

AU - Schmidt, Tobias

AU - Kreidel, Felix

AU - Bader, Ralf

AU - Kuck, Karl-Heinz

AU - Schäfer, Ulrich

PY - 2015/5

Y1 - 2015/5

N2 - BACKGROUND: We compare the feasibility and outcomes of "off-label" transcatheter aortic valve implantation (TAVI) patients with a standard "on-label" TAVI population.METHODS: A total of 591 high-risk patients (pts) underwent a TAVI procedure at our institution. Of these, 435 pts (73.6%) were treated for an on-label indication (group A) and 156 pts (26.4%) were treated for an off-label indication (group B). Group B was further subdivided into patients with pure aortic regurgitation (n = 22; group B.1), anatomical considerations (n = 26; group B.2), very low ejection fraction ≤20% (n = 12; group B.3), concomitant severe mitral regurgitation >2+ (n = 44; group B.4), degenerated aortic bioprosthesis (n = 30; group B.5), and hemodynamic instability with the need for cardiopulmonary bypass (n = 22; group B.6). Outcome parameters were classified according to the Valve Academic Research Consortium-2 criteria.RESULTS: The mean log EuroSCORE of the entire study group was 25 ± 16% (33 ± 21% in group B vs 22 ± 14% in group A; P<.001). Overall device success was 90% (91.3% in group A vs 86.5% in group B; P=.02). Overall 30-day mortality was 9.7%. Group B had a higher 30-day mortality compared with group A (14.7% vs 7.8%, respectively; P=.01). Group B.5 had the lowest 30-day mortality (3.3%).CONCLUSION: Corresponding to the higher surgical risk of group B, 30-day mortality was higher for off-label pts. Patients treated as valve-in-valve had the lowest 30-day mortality, emphasizing its great potential as opposed to redo open-heart surgery.

AB - BACKGROUND: We compare the feasibility and outcomes of "off-label" transcatheter aortic valve implantation (TAVI) patients with a standard "on-label" TAVI population.METHODS: A total of 591 high-risk patients (pts) underwent a TAVI procedure at our institution. Of these, 435 pts (73.6%) were treated for an on-label indication (group A) and 156 pts (26.4%) were treated for an off-label indication (group B). Group B was further subdivided into patients with pure aortic regurgitation (n = 22; group B.1), anatomical considerations (n = 26; group B.2), very low ejection fraction ≤20% (n = 12; group B.3), concomitant severe mitral regurgitation >2+ (n = 44; group B.4), degenerated aortic bioprosthesis (n = 30; group B.5), and hemodynamic instability with the need for cardiopulmonary bypass (n = 22; group B.6). Outcome parameters were classified according to the Valve Academic Research Consortium-2 criteria.RESULTS: The mean log EuroSCORE of the entire study group was 25 ± 16% (33 ± 21% in group B vs 22 ± 14% in group A; P<.001). Overall device success was 90% (91.3% in group A vs 86.5% in group B; P=.02). Overall 30-day mortality was 9.7%. Group B had a higher 30-day mortality compared with group A (14.7% vs 7.8%, respectively; P=.01). Group B.5 had the lowest 30-day mortality (3.3%).CONCLUSION: Corresponding to the higher surgical risk of group B, 30-day mortality was higher for off-label pts. Patients treated as valve-in-valve had the lowest 30-day mortality, emphasizing its great potential as opposed to redo open-heart surgery.

KW - Aged, 80 and over

KW - Aortic Valve/surgery

KW - Aortic Valve Stenosis/diagnosis

KW - Bioprosthesis

KW - Feasibility Studies

KW - Female

KW - Follow-Up Studies

KW - Heart Valve Prosthesis

KW - Humans

KW - Male

KW - Patient Selection

KW - Prosthesis Design

KW - Retrospective Studies

KW - Risk Factors

KW - Transcatheter Aortic Valve Replacement/methods

KW - Treatment Outcome

M3 - SCORING: Journal article

C2 - 25929299

VL - 27

SP - 229

EP - 236

JO - J INVASIVE CARDIOL

JF - J INVASIVE CARDIOL

SN - 1042-3931

IS - 5

ER -