Universität zu Köln

Mazzitelli, Domenico, Fischlein, Theodor, Rankin, J. Scott, Choi, Yeong-Hoon, Stamm, Christof, Pfeiffer, Steffen, Pirk, Jan, Detter, Christian, Kroll, Johannes, Beyersdorf, Friedhelm ORCID: 0000-0003-2975-2751, Griffin, Charles D., Shrestha, Malakh, Noebauer, Christian, Crooke, Philip S., Schreiber, Christian and Lange, Ruediger (2016). Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur. J. Cardio-Thorac. Surg., 49 (3). S. 987 - 994. CARY: OXFORD UNIV PRESS INC. ISSN 1873-734X

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Abstract

This study assessed the safety and efficacy of an internal geometric annuloplasty ring in a regulatory trial of aortic valve reconstruction (ClinicalTrials.gov Identifier: NCT01400841). Sixty-five patients with predominant moderate-to-severe trileaflet aortic insufficiency (AI) underwent aortic valve repair with an average age of 63 +/- 13 years (mean +/- SD). All had initial implantation of an internal aortic annuloplasty ring to correct annular dilatation and facilitate leaflet reconstruction. Leaflet plication was performed for prolapse in 80% of patients, and more complex leaflet procedures, usually employing autologous pericardium, were required in 22%. Ascending aortic and/or root aneurysms were replaced in 62%. Follow-up was for a maximum of 3 years and a mean of 2 years. No in-hospital operative mortalities, major complications or early or late valve-related events occurred. The annular diameter before repair was 26.5 +/- 2.3 mm, and the average ring diameter used was 21.5 +/- 1.6 mm. The preoperative AI grade (0-4) was 2.9 +/- 0.8 and improved after repair to 0.6 +/- 0.7 (P < 0.0001), as did the NYHA class. The mean valve gradient was 8.6 +/- 4.3 mmHg, and at 3 years, the Kaplan-Meier survival rate was 95%, with no valve-related mortality. Over the 3 years, aortic valve replacement was required in 7 patients (10.8%) for reasons usually related to surgical technique. Most repair failures occurred early, and results stabilized after 6 months. No structural complications of the rings were observed. Geometric ring annuloplasty was a safe and effective adjunct to aortic valve repair. Initial correction of annular dilatation seemed to facilitate overall reconstruction. Because most early repair failures were technical, increasing experience with geometric ring annuloplasty for aortic valve reconstruction has the potential to standardize and improve outcomes.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Mazzitelli, Domenico UNSPECIFIED UNSPECIFIED UNSPECIFIED Fischlein, Theodor UNSPECIFIED UNSPECIFIED UNSPECIFIED Rankin, J. Scott UNSPECIFIED UNSPECIFIED UNSPECIFIED Choi, Yeong-Hoon UNSPECIFIED UNSPECIFIED UNSPECIFIED Stamm, Christof UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfeiffer, Steffen UNSPECIFIED UNSPECIFIED UNSPECIFIED Pirk, Jan UNSPECIFIED UNSPECIFIED UNSPECIFIED Detter, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Kroll, Johannes UNSPECIFIED UNSPECIFIED UNSPECIFIED Beyersdorf, Friedhelm UNSPECIFIED orcid.org/0000-0003-2975-2751 UNSPECIFIED Griffin, Charles D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Shrestha, Malakh UNSPECIFIED UNSPECIFIED UNSPECIFIED Noebauer, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Crooke, Philip S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schreiber, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Lange, Ruediger UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-283651
DOI:	10.1093/ejcts/ezv234
Journal or Publication Title:	Eur. J. Cardio-Thorac. Surg.
Volume:	49
Number:	3
Page Range:	S. 987 - 994
Date:	2016
Publisher:	OXFORD UNIV PRESS INC
Place of Publication:	CARY
ISSN:	1873-734X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language RECONSTRUCTION; SURGERY; REGURGITATION; REPLACEMENT; MORTALITY Multiple languages Cardiac & Cardiovascular Systems; Respiratory System; Surgery Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28365