Universität zu Köln

Nickenig, Georg, Kowalski, Marek, Hausleiter, Joerg, Braun, Daniel, Schofer, Joachim, Yzeiraj, Ermela, Rudolph, Volker, Friedrichs, Kai, Maisano, Francesco ORCID: 0000-0002-3691-1709, Taramasso, Maurizio, Fam, Neil, Bianchi, Giovanni, Bedogni, Francesco, Denti, Paolo ORCID: 0000-0002-3075-0203, Alfieri, Ottavio, Latib, Azeem ORCID: 0000-0001-9035-343X, Colombo, Antonio, Hammerstingl, Christoph and Schueler, Robert (2017). Transcatheter Treatment of Severe Tricuspid Regurgitation With the Edge-to-Edge MitraClip Technique. Circulation, 135 (19). S. 1802 - 1832. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1524-4539

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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+/-0.3cm(2) versus 0.4+/-0.2cm(2); 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Nickenig, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Kowalski, Marek UNSPECIFIED UNSPECIFIED UNSPECIFIED Hausleiter, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Braun, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Schofer, Joachim UNSPECIFIED UNSPECIFIED UNSPECIFIED Yzeiraj, Ermela UNSPECIFIED UNSPECIFIED UNSPECIFIED Rudolph, Volker UNSPECIFIED UNSPECIFIED UNSPECIFIED Friedrichs, Kai UNSPECIFIED UNSPECIFIED UNSPECIFIED Maisano, Francesco UNSPECIFIED orcid.org/0000-0002-3691-1709 UNSPECIFIED Taramasso, Maurizio UNSPECIFIED UNSPECIFIED UNSPECIFIED Fam, Neil UNSPECIFIED UNSPECIFIED UNSPECIFIED Bianchi, Giovanni UNSPECIFIED UNSPECIFIED UNSPECIFIED Bedogni, Francesco UNSPECIFIED UNSPECIFIED UNSPECIFIED Denti, Paolo UNSPECIFIED orcid.org/0000-0002-3075-0203 UNSPECIFIED Alfieri, Ottavio UNSPECIFIED UNSPECIFIED UNSPECIFIED Latib, Azeem UNSPECIFIED orcid.org/0000-0001-9035-343X UNSPECIFIED Colombo, Antonio UNSPECIFIED UNSPECIFIED UNSPECIFIED Hammerstingl, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Schueler, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-231265
DOI:	10.1161/CIRCULATIONAHA.116.024848
Journal or Publication Title:	Circulation
Volume:	135
Number:	19
Page Range:	S. 1802 - 1832
Date:	2017
Publisher:	LIPPINCOTT WILLIAMS & WILKINS
Place of Publication:	PHILADELPHIA
ISSN:	1524-4539
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PROGNOSTIC IMPLICATIONS; EUROPEAN ASSOCIATION; VALVE REPAIR; ECHOCARDIOGRAPHY; ANNULOPLASTY; CONCOMITANT; EXPERIENCE; DIAGNOSIS; SURGERY; PATIENT Multiple languages Cardiac & Cardiovascular Systems; Peripheral Vascular Disease Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/23126