Transcatheter Treatment of Severe Tricuspid Regurgitation With the Edge-to-Edge MitraClip Technique

G Nickenig, M Kowalski, J Hausleiter, D Braun, J Schofer, E Yzeiraj, V Rudolph, K Friedrichs, F Maisano, M Taramasso, N Fam, G Bianchi, F Bedogni, Paolo Denti, O Alfieri, A Latib, A Colombo, C Hammerstingl, R Schueler

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Current surgical and medical treatment options for severe tricuspid regurgitation (TR) are limited, and additional interventional approaches are required. In the present observational study, the safety and feasibility of transcatheter repair of chronic severe TR with the MitraClip system were evaluated. In addition, the effects on clinical symptoms were assessed. METHODS: Patients with heart failure symptoms and severe TR on optimal medical treatment were treated with the MitraClip system. Safety, defined as periprocedural adverse events such as death, myocardial infarction, stroke, or cardiac tamponade, and feasibility, defined as successful implantation of 1 or more MitraClip devices and reduction of TR by at least 1 grade, were evaluated before discharge and after 30 days. In addition, functional outcome, defined as changes in New York Heart Assocation class and 6-minute walking distance, were assessed. RESULTS: We included 64 consecutive patients (mean age 76.6±10 years) deemed unsuitable for surgery who underwent MitraClip treatment for chronic, severe TR for compassionate use. Functional TR was present in 88%; in addition, 22 patients were also treated with the MitraClip system for mitral regurgitation as a combined procedure. The degree of TR was severe or massive in 88% of patients before the procedure. The MitraClip device was successfully implanted in the tricuspid valve in 97% of the cases. After the procedure, TR was reduced by at least 1 grade in 91% of the patients, thereof 4% that were reduced from massive to severe. In 13% of patients, TR remained severe after the procedure. Significant reductions in effective regurgitant orifice area (0.9±0.3cm2 versus 0.4±0.2cm2; P
Original languageEnglish
Pages (from-to)1802-1814
Number of pages13
JournalCirculation
Volume135
Issue number19
DOIs
Publication statusPublished - 2017

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Tricuspid Valve Insufficiency
Therapeutics
Compassionate Use Trials
Safety
Equipment and Supplies
Cardiac Tamponade
Tricuspid Valve
Mitral Valve Insufficiency
Walking
Observational Studies
Heart Failure
Stroke
Myocardial Infarction

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Nickenig, G., Kowalski, M., Hausleiter, J., Braun, D., Schofer, J., Yzeiraj, E., ... Schueler, R. (2017). Transcatheter Treatment of Severe Tricuspid Regurgitation With the Edge-to-Edge MitraClip Technique. Circulation, 135(19), 1802-1814. https://doi.org/10.1161/CIRCULATIONAHA.116.024848

Transcatheter Treatment of Severe Tricuspid Regurgitation With the Edge-to-Edge MitraClip Technique. / Nickenig, G; Kowalski, M; Hausleiter, J; Braun, D; Schofer, J; Yzeiraj, E; Rudolph, V; Friedrichs, K; Maisano, F; Taramasso, M; Fam, N; Bianchi, G; Bedogni, F; Denti, Paolo; Alfieri, O; Latib, A; Colombo, A; Hammerstingl, C; Schueler, R.

In: Circulation, Vol. 135, No. 19, 2017, p. 1802-1814.

Research output: Contribution to journalArticle

Nickenig, G, Kowalski, M, Hausleiter, J, Braun, D, Schofer, J, Yzeiraj, E, Rudolph, V, Friedrichs, K, Maisano, F, Taramasso, M, Fam, N, Bianchi, G, Bedogni, F, Denti, P, Alfieri, O, Latib, A, Colombo, A, Hammerstingl, C & Schueler, R 2017, 'Transcatheter Treatment of Severe Tricuspid Regurgitation With the Edge-to-Edge MitraClip Technique', Circulation, vol. 135, no. 19, pp. 1802-1814. https://doi.org/10.1161/CIRCULATIONAHA.116.024848
Nickenig, G ; Kowalski, M ; Hausleiter, J ; Braun, D ; Schofer, J ; Yzeiraj, E ; Rudolph, V ; Friedrichs, K ; Maisano, F ; Taramasso, M ; Fam, N ; Bianchi, G ; Bedogni, F ; Denti, Paolo ; Alfieri, O ; Latib, A ; Colombo, A ; Hammerstingl, C ; Schueler, R. / Transcatheter Treatment of Severe Tricuspid Regurgitation With the Edge-to-Edge MitraClip Technique. In: Circulation. 2017 ; Vol. 135, No. 19. pp. 1802-1814.
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abstract = "BACKGROUND: Current surgical and medical treatment options for severe tricuspid regurgitation (TR) are limited, and additional interventional approaches are required. In the present observational study, the safety and feasibility of transcatheter repair of chronic severe TR with the MitraClip system were evaluated. In addition, the effects on clinical symptoms were assessed. METHODS: Patients with heart failure symptoms and severe TR on optimal medical treatment were treated with the MitraClip system. Safety, defined as periprocedural adverse events such as death, myocardial infarction, stroke, or cardiac tamponade, and feasibility, defined as successful implantation of 1 or more MitraClip devices and reduction of TR by at least 1 grade, were evaluated before discharge and after 30 days. In addition, functional outcome, defined as changes in New York Heart Assocation class and 6-minute walking distance, were assessed. RESULTS: We included 64 consecutive patients (mean age 76.6±10 years) deemed unsuitable for surgery who underwent MitraClip treatment for chronic, severe TR for compassionate use. Functional TR was present in 88{\%}; in addition, 22 patients were also treated with the MitraClip system for mitral regurgitation as a combined procedure. The degree of TR was severe or massive in 88{\%} of patients before the procedure. The MitraClip device was successfully implanted in the tricuspid valve in 97{\%} of the cases. After the procedure, TR was reduced by at least 1 grade in 91{\%} of the patients, thereof 4{\%} that were reduced from massive to severe. In 13{\%} of patients, TR remained severe after the procedure. Significant reductions in effective regurgitant orifice area (0.9±0.3cm2 versus 0.4±0.2cm2; P",
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T1 - Transcatheter Treatment of Severe Tricuspid Regurgitation With the Edge-to-Edge MitraClip Technique

AU - Nickenig, G

AU - Kowalski, M

AU - Hausleiter, J

AU - Braun, D

AU - Schofer, J

AU - Yzeiraj, E

AU - Rudolph, V

AU - Friedrichs, K

AU - Maisano, F

AU - Taramasso, M

AU - Fam, N

AU - Bianchi, G

AU - Bedogni, F

AU - Denti, Paolo

AU - Alfieri, O

AU - Latib, A

AU - Colombo, A

AU - Hammerstingl, C

AU - Schueler, R

PY - 2017

Y1 - 2017

N2 - BACKGROUND: Current surgical and medical treatment options for severe tricuspid regurgitation (TR) are limited, and additional interventional approaches are required. In the present observational study, the safety and feasibility of transcatheter repair of chronic severe TR with the MitraClip system were evaluated. In addition, the effects on clinical symptoms were assessed. METHODS: Patients with heart failure symptoms and severe TR on optimal medical treatment were treated with the MitraClip system. Safety, defined as periprocedural adverse events such as death, myocardial infarction, stroke, or cardiac tamponade, and feasibility, defined as successful implantation of 1 or more MitraClip devices and reduction of TR by at least 1 grade, were evaluated before discharge and after 30 days. In addition, functional outcome, defined as changes in New York Heart Assocation class and 6-minute walking distance, were assessed. RESULTS: We included 64 consecutive patients (mean age 76.6±10 years) deemed unsuitable for surgery who underwent MitraClip treatment for chronic, severe TR for compassionate use. Functional TR was present in 88%; in addition, 22 patients were also treated with the MitraClip system for mitral regurgitation as a combined procedure. The degree of TR was severe or massive in 88% of patients before the procedure. The MitraClip device was successfully implanted in the tricuspid valve in 97% of the cases. After the procedure, TR was reduced by at least 1 grade in 91% of the patients, thereof 4% that were reduced from massive to severe. In 13% of patients, TR remained severe after the procedure. Significant reductions in effective regurgitant orifice area (0.9±0.3cm2 versus 0.4±0.2cm2; P

AB - BACKGROUND: Current surgical and medical treatment options for severe tricuspid regurgitation (TR) are limited, and additional interventional approaches are required. In the present observational study, the safety and feasibility of transcatheter repair of chronic severe TR with the MitraClip system were evaluated. In addition, the effects on clinical symptoms were assessed. METHODS: Patients with heart failure symptoms and severe TR on optimal medical treatment were treated with the MitraClip system. Safety, defined as periprocedural adverse events such as death, myocardial infarction, stroke, or cardiac tamponade, and feasibility, defined as successful implantation of 1 or more MitraClip devices and reduction of TR by at least 1 grade, were evaluated before discharge and after 30 days. In addition, functional outcome, defined as changes in New York Heart Assocation class and 6-minute walking distance, were assessed. RESULTS: We included 64 consecutive patients (mean age 76.6±10 years) deemed unsuitable for surgery who underwent MitraClip treatment for chronic, severe TR for compassionate use. Functional TR was present in 88%; in addition, 22 patients were also treated with the MitraClip system for mitral regurgitation as a combined procedure. The degree of TR was severe or massive in 88% of patients before the procedure. The MitraClip device was successfully implanted in the tricuspid valve in 97% of the cases. After the procedure, TR was reduced by at least 1 grade in 91% of the patients, thereof 4% that were reduced from massive to severe. In 13% of patients, TR remained severe after the procedure. Significant reductions in effective regurgitant orifice area (0.9±0.3cm2 versus 0.4±0.2cm2; P

U2 - 10.1161/CIRCULATIONAHA.116.024848

DO - 10.1161/CIRCULATIONAHA.116.024848

M3 - Article

VL - 135

SP - 1802

EP - 1814

JO - Circulation

JF - Circulation

SN - 0009-7322

IS - 19

ER -