70992
document
A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty . BACKGROUND Annular stabilization is important during bicuspid aortic valve ( BAV ) repair to obtain the best long-term results . This report describes the early outcomes of a novel bicuspid annuloplasty ring for this purpose . METHODS Under regulatory supervision ( NCT02071849 ) , a geometric bicuspid annuloplasty ring was used during valve repair in 16 patients . Three patients had Sievers type 0 valves , 11 had Sievers type 1 , and 2 had Sievers type 2 . Thirteen patients had left-/right-coronary cusp fusion , 1 had right-/noncoronary cusp fusion , and 2 had both . Moderate to severe aortic insufficiency ( AI ) was present in 13 of 16 patients , and 3 had mild AI with aortic aneurysms . Ascending aortic aneurysms , root aneurysms , or both were replaced in 7 of 16 patients . The Dacron-covered titanium ring had circular base geometry and two outwardly flaring subcommissural posts positioned opposite on the circumference . The ring was implanted into the annulus beneath the valve , and then leaflet repair was performed . RESULTS Immediate postrepair echocardiograms showed grade 0 residual AI in all patients , with good cusp mobility and effective height , and satisfactory gradients . There were no in-hospital or late mortalities . Two patients experienced leaflet tears from long annular suture tails , requiring late valve replacement . After implementation of a lateral suture fixation technique , no more failures occurred . At a mean follow-up time of 9 months , the remaining 14 patients were in New York Heart Association class I , with predominant grade 0 AI . CONCLUSIONS As a technique for BAV repair , internal ring annuloplasty produces major annular remodeling and stabilization . Annular reduction and reshaping to a 50/50 % symmetric circular geometry facilitates leaflet repair and enhances cusp coaptation . Geometric ring annuloplasty could have useful applications in BAV repair .
70993
Intervention_Surgical
Geometric Ring Annuloplasty
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Intervention_Surgical
geometric bicuspid annuloplasty ring
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Intervention_Physical
Dacron-covered titanium ring
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Outcome_Other
Immediate postrepair echocardiograms showed grade 0 residual
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Outcome_Other
cusp mobility and effective height , and satisfactory gradients
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Outcome_Adverse-effects
no in-hospital or late mortalities
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Outcome_Adverse-effects
experienced leaflet tears
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Outcome_Adverse-effects
requiring late valve replacement
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Outcome_Other
more failures
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Outcome_Other
in New York Heart Association class
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Outcome_Other
predominant grade 0 AI
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Participant_Condition
valve repair
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Participant_Sample-size
16
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Participant_Sample-size
Three patients
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Participant_Sample-size
11
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Participant_Sample-size
2
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Participant_Sample-size
Thirteen patients