Transcatheter Treatment of Severe Tricuspid Regurgitation With the Edge-to-Edge MitraClip Technique.
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±0.3cm2versus 0.4±0.2cm2;P<0.001), vena contracta width (1.1±0.5 cm versus 0.6±0.3 cm;P=0.001), and regurgitant volume (57.2±12.8 mL/beat versus 30.8±6.9 mL/beat;P<0.001) were observed. No intraprocedural deaths, cardiac tamponade, emergency surgery, stroke, myocardial infarction, or major vascular complications occurred. Three (5%) in-hospital deaths occurred. New York Heart Association class was significantly improved (P<0.001), and 6-minute walking distance increased significantly (165.9±102.5 m versus 193.5±115.9 m;P=0.007).


CONCLUSIONS
Transcatheter treatment of TR with the MitraClip system seems to be safe and feasible in this cohort of preselected patients. Initial efficacy analysis showed encouraging reduction of TR, which may potentially result in improved clinical outcomes.
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.). georg.nickenig@ukbonn.de.
Georg
G
Nickenig
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Marek
M
Kowalski
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Jörg
J
Hausleiter
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Daniel
D
Braun
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Joachim
J
Schofer
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Ermela
E
Yzeiraj
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Volker
V
Rudolph
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Kai
K
Friedrichs
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Francesco
F
Maisano
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Maurizio
M
Taramasso
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Neil
N
Fam
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Giovanni
G
Bianchi
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Francesco
F
Bedogni
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Paolo
P
Denti
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Ottavio
O
Alfieri
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Azeem
A
Latib
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Antonio
A
Colombo
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Christoph
C
Hammerstingl
From Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Germany (G.N., C.H., R.S.); Heart Center Osnabrück-Bad Rothenfelde, Schüchterman Klinik, Bad Rothenfelde, Germany (M.K.); Department of Cardiology, Ludwig- Maximilians University Munich, Germany (J.H., D.B.); Hamburg Universitary Cardiovascular Center, Germany (J.S., E.Y.); Heart Center, University of Cologne, Germany (V.R., K.F.); Department of Cardiac and Vascular Surgery, University Hospital Zürich, Switzerland (F.M., M.T.); Department of Interventional Cardiology, St. Michael's Hospital, Toronto, Canada (N.F.); Department of Cardiology, Policlinico San Donato, Milan, Italy (G.B., F.B.); Department of Cardiac Surgery, Ospedale San Raffaele, Milan, Italy (P.D., O.A.); and Department of Interventional Cardiology, Ospedale San Raffaele Milano, Milan, Italy (A.L., A.C.).
Robert
R
Schueler
D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000379:methods*; D015331:Cohort Studies; D017548:Echocardiography, Transesophageal / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D012720:Severity of Illness Index; D013525:Surgical Instruments / Q000706:statistics & numerical data; D016896:Treatment Outcome; D014262:Tricuspid Valve Insufficiency / Q000000981:diagnostic imaging* / Q000628:therapy*
MitraClip; heart failure; percutaneous repair; tricuspid regurgitation