Hemodynamic outcomes of geometric ring annuloplasty for aortic valve repair: a 4-center pilot trial
Language English Country United States Media print-electronic
Document type Clinical Trial, Journal Article, Multicenter Study
PubMed
24113022
DOI
10.1016/j.jtcvs.2013.08.031
PII: S0022-5223(13)00951-3
Knihovny.cz E-resources
- MeSH
- Cardiac Valve Annuloplasty instrumentation MeSH
- Aortic Valve diagnostic imaging physiopathology surgery MeSH
- Aortic Valve Insufficiency diagnosis physiopathology surgery MeSH
- Echocardiography, Doppler, Color MeSH
- Time Factors MeSH
- Heart Valve Prosthesis Implantation instrumentation MeSH
- Echocardiography, Transesophageal MeSH
- Hemodynamics * MeSH
- Middle Aged MeSH
- Humans MeSH
- Recovery of Function MeSH
- Pilot Projects MeSH
- Polyethylene Terephthalates MeSH
- Prosthesis Design MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Heart Valve Prosthesis * MeSH
- Severity of Illness Index MeSH
- Titanium MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
- Geographicals
- Europe MeSH
- Names of Substances
- Polyethylene Terephthalates MeSH
- Titanium MeSH
OBJECTIVES: A geometric annuloplasty ring could improve efficacy and stability of aortic valve repair. Toward this goal, a 1-piece 3-dimensional titanium annuloplasty ring with Dacron covering was developed and tested successfully in animals. The purpose of this study was to define hemodynamic outcomes with this device used as the annuloplasty component of human aortic valve repair. METHODS: In a 4-center pilot trial with informed consent, 16 patients underwent aortic valve repair for aortic insufficiency, with the annuloplasty device sutured into the annulus beneath the leaflets. Preoperative annular diameter averaged 26.5 ± 2.0 (mean ± standard deviation) mm, and average ring size was 22.3 ± 1.2 mm. After annuloplasty, leaflet defects were easy to identify, and 14 of 16 patients (88%) required leaflet plication and/or autologous pericardial reconstruction for leaflet defects. Three patients had ascending aortic replacement, and 2 had remodeling root replacement. One had ultrasonic leaflet decalcification and another tricuspid valve annuloplasty. Follow-up data were from site-specific studies at the 6-month postoperative time point. RESULTS: There were no in-hospital mortalities or major complications. Preoperative aortic insufficiency grade (0-4 scale) was 3.6 ± 1.0 and fell to 1.0 ± 0.8 at 6 months (P < .0001). New York Heart Association class fell from 2.5 ± 0.5 to 1.1 ± 0.3 (P < .0001). Postrepair valve area was 2.7 ± 0.2 cm(2), and 6-month mean systolic gradient was 11.3 ± 3.3 mm Hg. Left ventricular end-diastolic diameter and ejection fraction both normalized (both P < .0001). CONCLUSIONS: Geometric ring annuloplasty facilitated aortic valve repair, allowing more precise reconstruction of leaflet defects. Aortic insufficiency reduction and systolic gradients were excellent, and expansion of valve reconstruction into broader categories of aortic valve disease seems indicated.
BioStable Science and Engineering Inc Austin Tex
Department of Cardiovascular Diseases Katholieke Universiteit Leuven Leuven Belgium
German Heart Center Berlin Berlin Germany
Institute for Clinical and Experimental Medicine Prague Czech Republic
References provided by Crossref.org
ClinicalTrials.gov
NCT01400841
