TY - JOUR
T1 - Early results of a novel technique for ring-reinforced aortic valve and root restoration
AU - Mazzitelli, Domenico
AU - Nöbauer, Christian
AU - Rankin, J. Scott
AU - Badiu, Catalin C.
AU - Dorfmeister, Magdalena
AU - Crooke, Philip S.
AU - Wagner, Anke
AU - Schreiber, Christian
AU - Lange, Rüdiger
N1 - Funding Information:
This trial of an investigational device was funded by BioStable Science and Engineering, Inc.
PY - 2014/3
Y1 - 2014/3
N2 - OBJECTIVES: Surgery for aortic root aneurysm without valve stenosis is increasingly being transformed from the Bentall procedure to valve-sparing aortic root remodelling or reimplantation. In this report, a new repair option is explored, with full functional 'restoration' of the aortic root complex using a geometric annuloplasty ring, leaflet repair, and sinus/ascending aortic replacement with a Valsalva graft. METHODS: The geometric annuloplasty ring restores elliptical annular shape and size in patients with tri-leaflet aortic insufficiency (AI). The ring mounts the three valve commissures on 10° outwardly flaring posts, and facilitates required leaflet procedures. In clinical application, the device has been effective in achieving stable AI reduction with low valve gradients. In this report, 6 patients with aortic root aneurysms and moderate/severe AI were managed with valve repair using the annuloplasty device and leaflet reconstruction, and then concomitant sinus and ascending aortic graft replacement with coronary implantation. RESULTS: In the 6 initial root aneurysm patients, there were no in-hospital mortalities, procedural conversions, or valve-related complications. Preoperative AI grade was 2-4 and fell to 0-1 postoperatively. Post-repair mean systolic gradients ranged from 7 to 12 mmHg, and all patients had stable intermediate-term valve function. CONCLUSIONS: Aortic root restoration using a geometric annuloplasty ring and Valsalva graft may be the most physiological method of aortic valve repair and root replacement. Even with severe leaflet derangements, valve sparing can be achieved with good competence and potentially stable long-term results. This technique could assist in extending valve sparing into most categories of aortic root disease. CLINICAL TRIALS: Patients were managed as part of a Phase I (ClinicalTrials.gov Identifier: NCT01400841), supported by BioStable Science and Engineering (BSE), Austin, TX, USA; www.biostable-s-e.com.
AB - OBJECTIVES: Surgery for aortic root aneurysm without valve stenosis is increasingly being transformed from the Bentall procedure to valve-sparing aortic root remodelling or reimplantation. In this report, a new repair option is explored, with full functional 'restoration' of the aortic root complex using a geometric annuloplasty ring, leaflet repair, and sinus/ascending aortic replacement with a Valsalva graft. METHODS: The geometric annuloplasty ring restores elliptical annular shape and size in patients with tri-leaflet aortic insufficiency (AI). The ring mounts the three valve commissures on 10° outwardly flaring posts, and facilitates required leaflet procedures. In clinical application, the device has been effective in achieving stable AI reduction with low valve gradients. In this report, 6 patients with aortic root aneurysms and moderate/severe AI were managed with valve repair using the annuloplasty device and leaflet reconstruction, and then concomitant sinus and ascending aortic graft replacement with coronary implantation. RESULTS: In the 6 initial root aneurysm patients, there were no in-hospital mortalities, procedural conversions, or valve-related complications. Preoperative AI grade was 2-4 and fell to 0-1 postoperatively. Post-repair mean systolic gradients ranged from 7 to 12 mmHg, and all patients had stable intermediate-term valve function. CONCLUSIONS: Aortic root restoration using a geometric annuloplasty ring and Valsalva graft may be the most physiological method of aortic valve repair and root replacement. Even with severe leaflet derangements, valve sparing can be achieved with good competence and potentially stable long-term results. This technique could assist in extending valve sparing into most categories of aortic root disease. CLINICAL TRIALS: Patients were managed as part of a Phase I (ClinicalTrials.gov Identifier: NCT01400841), supported by BioStable Science and Engineering (BSE), Austin, TX, USA; www.biostable-s-e.com.
KW - Annuloplasty ring
KW - Aortic aneurysm
KW - Aortic root restoration
KW - Aortic valve
KW - Aortic valve repair
KW - Ring annuloplasty
KW - Valve repair
KW - Valve sparing
UR - http://www.scopus.com/inward/record.url?scp=84894327424&partnerID=8YFLogxK
U2 - 10.1093/ejcts/ezt407
DO - 10.1093/ejcts/ezt407
M3 - Article
C2 - 23959743
AN - SCOPUS:84894327424
SN - 1010-7940
VL - 45
SP - 426
EP - 430
JO - European Journal of Cardio-thoracic Surgery
JF - European Journal of Cardio-thoracic Surgery
IS - 3
M1 - ezt407
ER -