Improving mitral valve coaptation with adjustable rings: Outcomes from a european multicentre feasibility study with a new-generation adjustable annuloplasty ring system

Francesco Maisano, Volkmar Falk, Michael A. Borger, Hugo Vanermen, Ottavio Alfieri, Joerg Seeburger, Stefan Jacobs, Michael Mack, Friederich W. Mohr

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

OBJECTIVES: To evaluate the performance and safety of an adjustable semi-rigid annuloplasty ring for mitral regurgitation (MR) in a multicentre study. METHODS: Between March 2010 and December 2011, 30 subjects underwent mitral valve (MV) repair using the Cardinal adjustable annuloplasty ring. This device is a semi-rigid ring allowing postimplantation size adjustment, under beating-heart conditions, to optimize leaflet coaptation under echocardiographic guidance. Coaptation length was determined before and after adjustment by transoesophageal echocardiography. RESULTS: The study enrolled 21 (70%) male and 9 (30%) female subjects with a mean age of 64 years. The approach was conventional midline sternotomy or mini-invasive right thoracotomy. Leaflet resection was done in 17 subjects, and chordal repair was used in 13. Concomitant procedures included coronary artery bypass grafting in 2 (7%) subjects, atrial ablation in 4 (13%) and tricuspid repair in 4 (13%). There was 1 (3%) early death unrelated to the study device. Intraoperative ring adjustment was performed in 24 of the 30 subjects. Residual MR was detected prior to adjustment in 6 subjects (4 mild and 2 moderate MR). Following adjustment, 5 subjects had no MR and 1 had trace MR. After adjustment, mean coaptation length improved from 7 ± 3 to 10 ± 3 mm (P <0.0001). All patients who completed 1-year follow-up had less-than-mild MR, with the exception of 1 patient with ring dehiscence (and resultant 2+ MR) and 1 functional MR patient who developed recurrent 2+ MR due to persistent leaflet tethering. CONCLUSIONS: MV repair with the Cardinal adjustable annuloplasty ring is a reliable technique that enables the adjustment of the ring diameter on a beating heart under echocardiographic control. Such technology allows the optimization of leaflet coaptation, providing minimal residual MR and durable repair.

Original languageEnglish
Article numberezt128
Pages (from-to)913-918
Number of pages6
JournalEuropean Journal of Cardio-thoracic Surgery
Volume44
Issue number5
DOIs
Publication statusPublished - Nov 2013

Fingerprint

Mitral Valve Insufficiency
Feasibility Studies
Mitral Valve
Multicenter Studies
Equipment and Supplies
Sternotomy
Transesophageal Echocardiography
Thoracotomy
Coronary Artery Bypass
Technology
Safety

Keywords

  • Annuloplasty
  • Coaptation length
  • Echocardiography
  • Image-guided surgery
  • Mitral valve
  • Reconstruction
  • Repair

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Pulmonary and Respiratory Medicine

Cite this

Improving mitral valve coaptation with adjustable rings : Outcomes from a european multicentre feasibility study with a new-generation adjustable annuloplasty ring system. / Maisano, Francesco; Falk, Volkmar; Borger, Michael A.; Vanermen, Hugo; Alfieri, Ottavio; Seeburger, Joerg; Jacobs, Stefan; Mack, Michael; Mohr, Friederich W.

In: European Journal of Cardio-thoracic Surgery, Vol. 44, No. 5, ezt128, 11.2013, p. 913-918.

Research output: Contribution to journalArticle

Maisano, Francesco ; Falk, Volkmar ; Borger, Michael A. ; Vanermen, Hugo ; Alfieri, Ottavio ; Seeburger, Joerg ; Jacobs, Stefan ; Mack, Michael ; Mohr, Friederich W. / Improving mitral valve coaptation with adjustable rings : Outcomes from a european multicentre feasibility study with a new-generation adjustable annuloplasty ring system. In: European Journal of Cardio-thoracic Surgery. 2013 ; Vol. 44, No. 5. pp. 913-918.
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abstract = "OBJECTIVES: To evaluate the performance and safety of an adjustable semi-rigid annuloplasty ring for mitral regurgitation (MR) in a multicentre study. METHODS: Between March 2010 and December 2011, 30 subjects underwent mitral valve (MV) repair using the Cardinal adjustable annuloplasty ring. This device is a semi-rigid ring allowing postimplantation size adjustment, under beating-heart conditions, to optimize leaflet coaptation under echocardiographic guidance. Coaptation length was determined before and after adjustment by transoesophageal echocardiography. RESULTS: The study enrolled 21 (70{\%}) male and 9 (30{\%}) female subjects with a mean age of 64 years. The approach was conventional midline sternotomy or mini-invasive right thoracotomy. Leaflet resection was done in 17 subjects, and chordal repair was used in 13. Concomitant procedures included coronary artery bypass grafting in 2 (7{\%}) subjects, atrial ablation in 4 (13{\%}) and tricuspid repair in 4 (13{\%}). There was 1 (3{\%}) early death unrelated to the study device. Intraoperative ring adjustment was performed in 24 of the 30 subjects. Residual MR was detected prior to adjustment in 6 subjects (4 mild and 2 moderate MR). Following adjustment, 5 subjects had no MR and 1 had trace MR. After adjustment, mean coaptation length improved from 7 ± 3 to 10 ± 3 mm (P <0.0001). All patients who completed 1-year follow-up had less-than-mild MR, with the exception of 1 patient with ring dehiscence (and resultant 2+ MR) and 1 functional MR patient who developed recurrent 2+ MR due to persistent leaflet tethering. CONCLUSIONS: MV repair with the Cardinal adjustable annuloplasty ring is a reliable technique that enables the adjustment of the ring diameter on a beating heart under echocardiographic control. Such technology allows the optimization of leaflet coaptation, providing minimal residual MR and durable repair.",
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T1 - Improving mitral valve coaptation with adjustable rings

T2 - Outcomes from a european multicentre feasibility study with a new-generation adjustable annuloplasty ring system

AU - Maisano, Francesco

AU - Falk, Volkmar

AU - Borger, Michael A.

AU - Vanermen, Hugo

AU - Alfieri, Ottavio

AU - Seeburger, Joerg

AU - Jacobs, Stefan

AU - Mack, Michael

AU - Mohr, Friederich W.

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N2 - OBJECTIVES: To evaluate the performance and safety of an adjustable semi-rigid annuloplasty ring for mitral regurgitation (MR) in a multicentre study. METHODS: Between March 2010 and December 2011, 30 subjects underwent mitral valve (MV) repair using the Cardinal adjustable annuloplasty ring. This device is a semi-rigid ring allowing postimplantation size adjustment, under beating-heart conditions, to optimize leaflet coaptation under echocardiographic guidance. Coaptation length was determined before and after adjustment by transoesophageal echocardiography. RESULTS: The study enrolled 21 (70%) male and 9 (30%) female subjects with a mean age of 64 years. The approach was conventional midline sternotomy or mini-invasive right thoracotomy. Leaflet resection was done in 17 subjects, and chordal repair was used in 13. Concomitant procedures included coronary artery bypass grafting in 2 (7%) subjects, atrial ablation in 4 (13%) and tricuspid repair in 4 (13%). There was 1 (3%) early death unrelated to the study device. Intraoperative ring adjustment was performed in 24 of the 30 subjects. Residual MR was detected prior to adjustment in 6 subjects (4 mild and 2 moderate MR). Following adjustment, 5 subjects had no MR and 1 had trace MR. After adjustment, mean coaptation length improved from 7 ± 3 to 10 ± 3 mm (P <0.0001). All patients who completed 1-year follow-up had less-than-mild MR, with the exception of 1 patient with ring dehiscence (and resultant 2+ MR) and 1 functional MR patient who developed recurrent 2+ MR due to persistent leaflet tethering. CONCLUSIONS: MV repair with the Cardinal adjustable annuloplasty ring is a reliable technique that enables the adjustment of the ring diameter on a beating heart under echocardiographic control. Such technology allows the optimization of leaflet coaptation, providing minimal residual MR and durable repair.

AB - OBJECTIVES: To evaluate the performance and safety of an adjustable semi-rigid annuloplasty ring for mitral regurgitation (MR) in a multicentre study. METHODS: Between March 2010 and December 2011, 30 subjects underwent mitral valve (MV) repair using the Cardinal adjustable annuloplasty ring. This device is a semi-rigid ring allowing postimplantation size adjustment, under beating-heart conditions, to optimize leaflet coaptation under echocardiographic guidance. Coaptation length was determined before and after adjustment by transoesophageal echocardiography. RESULTS: The study enrolled 21 (70%) male and 9 (30%) female subjects with a mean age of 64 years. The approach was conventional midline sternotomy or mini-invasive right thoracotomy. Leaflet resection was done in 17 subjects, and chordal repair was used in 13. Concomitant procedures included coronary artery bypass grafting in 2 (7%) subjects, atrial ablation in 4 (13%) and tricuspid repair in 4 (13%). There was 1 (3%) early death unrelated to the study device. Intraoperative ring adjustment was performed in 24 of the 30 subjects. Residual MR was detected prior to adjustment in 6 subjects (4 mild and 2 moderate MR). Following adjustment, 5 subjects had no MR and 1 had trace MR. After adjustment, mean coaptation length improved from 7 ± 3 to 10 ± 3 mm (P <0.0001). All patients who completed 1-year follow-up had less-than-mild MR, with the exception of 1 patient with ring dehiscence (and resultant 2+ MR) and 1 functional MR patient who developed recurrent 2+ MR due to persistent leaflet tethering. CONCLUSIONS: MV repair with the Cardinal adjustable annuloplasty ring is a reliable technique that enables the adjustment of the ring diameter on a beating heart under echocardiographic control. Such technology allows the optimization of leaflet coaptation, providing minimal residual MR and durable repair.

KW - Annuloplasty

KW - Coaptation length

KW - Echocardiography

KW - Image-guided surgery

KW - Mitral valve

KW - Reconstruction

KW - Repair

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