Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device
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Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. / Mazzitelli, Domenico; Fischlein, Theodor; Rankin, J Scott; Choi, Yeong-Hoon; Stamm, Christof; Pfeiffer, Steffen; Pirk, Jan; Detter, Christian; Kroll, Johannes; Beyersdorf, Friedhelm; Griffin, Charles D; Shrestha, Malakh; Nöbauer, Christian; Crooke, Philip S; Schreiber, Christian; Lange, Rüdiger.
In: EUR J CARDIO-THORAC, Vol. 49, No. 3, 03.2016, p. 987-993.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device
AU - Mazzitelli, Domenico
AU - Fischlein, Theodor
AU - Rankin, J Scott
AU - Choi, Yeong-Hoon
AU - Stamm, Christof
AU - Pfeiffer, Steffen
AU - Pirk, Jan
AU - Detter, Christian
AU - Kroll, Johannes
AU - Beyersdorf, Friedhelm
AU - Griffin, Charles D
AU - Shrestha, Malakh
AU - Nöbauer, Christian
AU - Crooke, Philip S
AU - Schreiber, Christian
AU - Lange, Rüdiger
N1 - © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
PY - 2016/3
Y1 - 2016/3
N2 - OBJECTIVES: 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).METHODS: 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%.RESULTS: 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.CONCLUSIONS: 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.
AB - OBJECTIVES: 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).METHODS: 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%.RESULTS: 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.CONCLUSIONS: 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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Aortic Valve/surgery
KW - Aortic Valve Insufficiency/surgery
KW - Cardiac Valve Annuloplasty/adverse effects
KW - Female
KW - Heart Valve Prosthesis/adverse effects
KW - Humans
KW - Male
KW - Middle Aged
KW - Prospective Studies
KW - Reoperation
U2 - 10.1093/ejcts/ezv234
DO - 10.1093/ejcts/ezv234
M3 - SCORING: Journal article
C2 - 26156945
VL - 49
SP - 987
EP - 993
JO - EUR J CARDIO-THORAC
JF - EUR J CARDIO-THORAC
SN - 1010-7940
IS - 3
ER -
