Is a flexible mitral annuloplasty ring superior to a semi-rigid or rigid ring in terms of improvement in symptoms and survival? n

Date First Published:
June 5, 2009
Last Updated:
August 21, 2009
Report by:
Tjian Cheea, Ross Haston, Athena Togo and Shahzad G. Rajab, Specialist Registrars in Cardiothoracic Surgery (Department of Cardiothoracic Surgery, Western Infirmary, Glasgow, Department of Cardiothoracic Surgery, Harefield Hospital, Hill End Road, Harefield)
Three-Part Question:
In [patients with mitral regurgitation secondary to degenerative mitral valve disease requiring a mitral valve repair with an annuloplasty ring] is a [flexible ring superior to a semi-rigid or rigid ring] in terms of [improvement in symptoms and survival]?
Clinical Scenario:
Your consultant is about to operate on a 48-year-old patient with moderate to severe mitral regurgitation (MR) due to degenerative disease of the mitral valve. The scrub nurse asks you about the type of ring that your boss is going to use. You say that he always uses a flexible ring. She asks you why and your boss overhears your rather unconvincing response and suggests that you go and look up the evidence rather than cannulating today.
Search Strategy:
Medline from 1950 through January 2008 using Ovid interface.
Search Details:
Mitral valve repair.mp OR mitral valve reconstruction.mp OR mitral valvuloplasty.mp] AND [Annuloplast$.mp OR valvuloplast$.mp] AND [Exp survival OR exp outcome OR outcome$.mp].
Outcome:
The ‘related articles’ function was used to broaden the search and all abstracts, studies, and citations scanned were reviewed. The reference lists of articles found through these searches were also reviewed for relevant articles. Only studies recruiting patients with MR secondary to degenerative mitral disease were included.

A total of 478 papers were found using the search strategy. Twelve papers were deemed to represent the best evidence on the topic and are summarised in the Table
Relevant Paper(s):
Study Title Patient Group Study type (level of evidence) Outcomes Key results Study Weaknesses
Biological versus prosthetic ring in mitral-valve repair: enhancement of mitral annulus dynamics and left-ventricular function with pericardial annuloplasty at long-term. Borghetti V, Campana M, Scotti C et al. 2000, Italy 44 patients undergoing mitral valve repair for degenerative MR<br><br>Autologous pericardial flexible ring (Group I) = 23 patients<br><br>Carpentier rigid ring (Group II) = 21 patients Retrospective study (level 2b) Postop MR No significant MR at rest or exercise in any patient Small sample size<br><br>No clinical outcomes<br><br>Retrospective study<br><br>Non-randomized<br><br>Direct vizualization of mitral annular dynamics was not performed<br><br>2D echocardiography used which does not give three-dimensional reconstruction of the mitral valve the gold standard for postoperative evaluation of functional or anatomical details of the valvular apparatus after mitral valve repair
MASE Better MASE at all the studied longitudinal segments at rest and during exercise only in Group I
TMFW Significant increase in both groups (P<0.0001)
Group I From 1.22±0.22 to 1.79±0.32 m/s, t=–8.8, P<0.0001
Group II From 1.19±0.17 to 1.96±0.33 m/s, t=–12.8, P<0.0001
Recruitment of LVEF reserve during exercise Significant only in Group I
Group I From 59.5±6% to 65.8±6%, tt=–3.95, P<0.005
Group II No change
Cosgrove-Edwards mitral ring dynamics measured with transesophageal three-dimensional echocardiography. Dall'Agata A, Taams MA, Fioretti PM et al. 1998, The Netherlands 19 patients undergoing mitral valve repair for degenerative MR<br><br>Cosgrove-Edwards flexible ring =15 patients. Carpentier rigid ring =4 patients Case control study (level 3b) Ring annular area Signicant change in the orifice area observed only in Cosgrove-Edwards flexible ring (P<0.0001) Small sample size<br><br>Non-randomised<br><br>No clinical outcomes
Cosgrove-Edwards flexible ring Systolic 4.21±1.50 cm2<br><br>Diastolyic 4.81±1.56 cm2
Carpentier rigid ring Systolic 3.80±0.77 cm2<br><br>Diastolyic 3.74±0.89 cm2
Ring AP diameter Significant change in the AP diameter observed only in Cosgrove-Edwards flexible ring (P<0.01)
Cosgrove-Edwards flexible ring Systolic 1.92±0.27 cm<br><br>Diastolic 2.05±0.22 cm
Carpentier rigid ring Systolic 1.77±0.20 cm<br><br>Diastolic 1.70±0.20 cm
Ring transverse diameter No significant change in transverse diameter for both rings
Cosgrove-Edwards flexible ring Systolic 2.45±0.48 cm<br><br>Diastolic 2.50±0.57 cm
Carpentier rigid ring Systolic 2.60±0.34 cm<br><br>Diastolic 2.57±0.42 cm
Three-dimensional echocardiographic evaluation of configuration and dynamics of the mitral annulus in patients fitted with an annuloplasty ring. Yamaura Y, Yoshida K, Hozumi T et al. 1997, Japan 20 patients undergoing mitral valve repair for degenerative MR<br><br>Carpentier rigid ring = 10 patients<br><br>Duran flexible ring = 10 patients Case control study (level 3b) Mitral annular configuration Carpentier ring planar<br><br>Duran ring Non-planar Small sample size<br><br>Non-randomized<br><br>No clinical outcomes
Change in mitral annular area during cardiac cycle Significant change only in Duran ring
Carpentier ring Unchanged
Duran ring 25±2% reduction
Comparison of the Carpentier and Duran prosthetic rings used in mitral reconstruction. Okada Y, Shomura T, Yamaura Y et al. 1995, Japan 26 patients undergoing mitral valve repair for degenerative MR<br><br>Carpentier ring = 11 patients<br><br>Duran flexible ring = 15 patients Case control study (level 3b) LV systolic function Similar Small sample size<br><br>Non-randomized<br><br>No clinical outcomes<br><br>LV systolic function measured at coronary angiography
Change in mitral annular area during cardiac cycle Significant change only in Duran ring
LV fractional shortening Significant difference<br><br>Carpentier ring 35.8%<br><br>Duran ring 43.4%
Peak velocity at peak exercise Significant difference<br><br>Carpentier ring 222 cm/s<br><br>Duran ring 186 cm/s
Three-dimensional analysis of configuration and dynamics in patients with an annuloplasty ring by multiplane transesophageal echocardiography: comparison between flexible and rigid annuloplasty rings. Yamaura Y, Yoshikawa J, Yoshida K et al. 1995, Japan 10 patients undergoing mitral valve repair for degenerative MR<br><br>Carpentier rigid ring = 5 patients<br><br>Duran flexible ring = 5 patients<br><br>Normal subjects = 5 patients Case control study (level 3b) LV systolic function Small sample size<br><br>Non-randomised<br><br>No clinical outcomes
Change in mitral annular area during cardiac cycle
LV fractional shortening
Peak velocity at peak exercise
Doppler echocardiographic comparison of the Carpentier and Duran anuloplasty rings versus no ring after mitral valve repair for mitral regurgitation. Unger-Graeber B, Lee RT, Sutton MS et al. 1991, USA 122 patients undergoing mitral valve repair<br><br>Carpentier rigid ring = 46 patients<br><br>Duran flexible ring = 48 patients<br><br>No ring = 28 patients Case control study (level 3b) Decrease in mitral valve area Significant decrease in mitral valve area only in patients with rings (P=0.01) Non-randomized<br><br>No clinical outcomes<br><br>Heterogenous causes of MR although 72 patients had degenerative MR<br><br>Only Doppler echocardiography used
Carpentier ring 2.6±0.8 cm2
Duran ring 2.8±0.8 cm2
No ring 3.2±0.7 cm2
Peak transmitral diastolic velocity Similar
Peak transmitral diastolic gradient Similar
Grade of mitral regurgitation Similar
Mitral valve annuloplasty: the effect of the type on left ventricular function. David TE, Komeda M, Pollick C et al. 1989, Canada 25 patients undergoing mitral valve repair for degenerative MR<br><br>Rigid ring = 13 patients<br><br>Flexible ring = 12 patients RCT (level 1b) Reduction in LVEDD Similar Sample size<br><br>No clinical outcomes<br><br>
Reduction in LVEDV Similar
Reduction in LVESD Significant reduction only in flexible ring group (P<0.05)
Reduction in LVESV Significant reduction only in flexible ring group (P<0.05)
LV systolic function Significantly better in patients with a flexible ring (P<0.02)
LV performance measured by stroke volume end-diastolic volume relationships Significantly better in patients with a flexible ring (P<0.05)
Long-term outcomes after mitral ring annuloplasty for degenerative mitral regurgitation: Duran ring versus Carpentier-Edwards ring. Chung CH, Kim JB, Choo SJ, et al. 2007, Korea 294 patients undergoing mitral valve repair for degenerative MR<br><br>Carpentier rigid ring = 153 patients<br><br>Duran flexible ring = 141 patients Retrospective study (level 2b) Overall survival Similar Retrospective study<br><br>Non-randomised
Reoperation-free survival Similar
Five year MR (grade ≥3) – free survival Similar (P=0.83)<br><br>CE group 75.1±4.6%<br><br>Duran group 82.4±4.5%
Five year MS (MPG ≥10 mmHg) – free survival rate Overall superior five-year MS-free<br><br>survival for CE group (P=0.011)<br><br>CE group 91.2±2.8%<br><br>65.1±10.7%
MPG ≥10 mmHg Significantly more Duran patients had an MPG of t≥10 mmHg
Change in LV ejection fraction LV mass and LV dimensions No change over time in either group
LV mass and LV dimensions LV mass and LV dimensionstdecreased significantly after surgery in both groups, but no significant inter-group difference was seen for either index
Long-term clinical results of mitral valvuloplasty using flexible and rigid rings: a prospective and randomized study. Chang BC, Youn YN, Ha JW et al. 2007, Korea 356 patients undergoing mitral valve repair<br><br>Carpentier rigid ring = 186 patients<br><br>Duran flexible ring = 170 patients RCT (level 1b) Operative/early death 4 (1.1%) CE 0, Duran 4 Heterogenous causes of MR although 236 patients had degenerative MR
Late death 21 (5.8%) CE 11, Duran 10
Survival rate Similar (P=0.74)
5-year survival 93.3±1.7% CE 95.6±1.7%, Duran 91.4±2.8%
10-year survival 77.4±8.0% CE 85.9±4.9%, Duran 75.7±7.2%
Significant MR (grade ≥3) 23 patients CE 8, Duran 15
Reoperation 8 patients
Progression of MR necessitating reoperation 5 patients CE 1, Duran 5
10-year freedom from anticoagulation-related haemorrhage 99.1±0.7% (P=0.16) CE 100%, 98.2±1.3%
10-year freedom from infective endocarditis 98.6±0.9% (P=0.56) CE 98.7±0.9%, 98.6±1.4%
Preop LVEF CE 62.5±11.8%, Duran 63.2±11.9%
Postop LVEF Significant but similar change for both groups (P<0.001), CE 55.9±13% , Duran 56.5±14.1%
Preop LVESD CE 46.2±11.7 mm, Duran 45.8±11.9 mm
Postop LVESD Significant but similar change for both groups (P<0.001), CE 42.1±10.1 mm, 41.2±10.5 mm
Preop LVEDD CE 58.3±12.3 mm, 59.4±11.7 mm
Postop LVEDD Significant but similar change for both groups (P<0.001), CE 48.6±10.3 mm, Duran 50.6±9.1 mm
Preop LAD CE 51.1±9.1 mm, Duran 52.8±11.2 mm
Postop LAD Significant but similar change for both groups (P<0.001), CE 44±8.6 mm, Duran 45.3±9.4 mm
The Carpentier-Edwards Classic and Physio mitral annuloplasty rings: a randomized trial. Shahin GM, van der Heijden GJ, Bots ML et al. 2005, The Netherlands 96 patients undergoing mitral valve repair<br><br>CE Classic rigid ring = 53 patients<br><br>CE Physio flexible ring = 43 patients RCT (level 1b) Mortality 16% difference in mortality (P=0.41), Physio group (n) 6, Classic group (n) 16 Analyses were adjusted for age and gender, and for factors that differed across groups at baseline
Intra-operative repair failure 7, Physio group 3, Classic group 4
Late failure 5, Physio group 4, Classic group 1
LV function LV function did not differ across groups (P=0.65), Physio 48%, Classic group 45%
Improvement in combined NYHA class III-IV Similar improvement, Physio group 34%, Classic group 42%
Mitral valve repair for degenerative disease: is pericardial posterior annuloplasty a durable option. Bevilacqua S, Cerillo AG, Gianetti J et al. 2003, Italy 133 patients undergoing mitral valve repair for degenerative MR<br><br>Carpentier rigid ring = 77 patients<br><br>Autologous pericardial ring = 56 patients Retrospective study (level 2b) 30-day mortality 3.8% (P>0.999), Prosthetic ring group (n) 3, Pericardial ring group (n) 2 Retrospective study<br><br>Bias related to learning curve as kind of implanted annuloplasty ring was not randomly assigned but varied during the study period<br><br>Confounding factors such glutaraldehyde fixation (time and concentration), pericardial ring modeling and implantation could be related to the unsatisfactory durability of pericardial ring
SAM 5.2% (P=0.083), Prosthetic ring group 4, Pericardial ring group 0
Five-year freedom from reoperation and recurrence of mitral regurgitation=≥3+/4+ Significantly higher in the prosthetic ring group (P=0.027), Prosthetic ring group 90.1% – CL90%: 81.9–98.3%, Pericardial ring group 62.6% – CL90%: 43.1–82.1%
Reoperation for recurrent mitral regurgitation at 16.7±15.6 months 11 patients (P=0.005), Prosthetic ring group 2, Pericardial ring group 9
Five-year freedom from death 93.3% (CL90%: 90.5–96.2%). The kind of annuloplasty ring showed no influence on long-term survival (P=0.519). Prosthetic ring group 95.8%; CL90%: 91.8–99.7%, Pericardial ring group 91.0; CL90%: 83.9–98.1%
Mitral valve annuloplasty for degenerative disease: assessment of four different techniques. Milano A, Codecasa R, De Carlo M et al. 2000, Italy 62 patients undergoing mitral valve repair for degenerative MR<br><br>Local posterior annuloplasty (group I, n = 10)<br><br>Rigid Carpentier ring (group 2, n = 20)<br><br>Duran ring (group 3, n = 17)<br><br>and Posterior annular plication with autologous pericardium (group 4, n = 15) Retrospective study (level 2b) Early death Nil Retrospective study<br><br>Small sample size<br><br>Non-randomised
Late death Nil
Reoperation One patient in group 2 required reoperation 14 months after repair
Residual MR In patients of groups 2, 3 and 4, residual mitral incompetence at follow-up was not significantly different from discharge<br><br> Group 1 A higher degree of residual mitral regurgitation was present at discharge (0.9±0.6) with a trend to progress at follow-up (1.6±0.5)<br><br> Group 2 0.8±0.9<br><br> Group 3 0.8±0.7<br><br> Group 4 0.2±0.6
Improvement in NYHA class In all groups there was a significant improvement in NYHA functional class (from 2.7±0.6 to 0.9±0.5, P<0.001)
LVESV In all groups there was a significant reduction of LVESV (64±23 ml to 52±22 ml, P<0.001)
LVEDV In all groups there was a significant reduction of LVEDV (154±50 ml to 105±33 ml, P<0.001)
Author Commentary:
Several sophisticated echocardiographic studies have demonstrated that patients with a flexible annuloplasty ring have better LV systolic function than patients with a rigid annuloplasty ring after mitral valve reconstruction for chronic MR secondary to degenerative disease of the mitral valve [Borghetti, Dall'Agata, Yamaura 1995 and 1997, Okada, Unger-Graeber, David].
Borghetti et al. in their retrospective study of 44 patients showed that autologous pericardium seems to be superior to rigid prosthetic rings for annuloplasty in MV repair, since it provides more favourable mitral annulus dynamics and preserves LV function during stress conditions. <br><br>Dall'Agata et al. in a small study of 19 patients showed that the Cosgrove-Edwards ring (n=15) maintains its flexibility early after implantation and demonstrates significant systolic–diastolic changes in the mitral orifice area during the cardiac cycle compared to Carpentier rigid ring (n=4). Similar findings have been reported by other authors [Yamaura 1995 and 1997, Okada, Unger-Graeber, David]. <br><br> Interestingly, clinical studies [Chung, Chang, Shahin, Bevilacqua, Milano] comparing outcomes of patients who underwent mitral valvuloplasty for degenerative MR with either a semi-rigid/rigid ring or flexible ring have shown comparable outcomes contrary to the findings of the echocardiographic studies.<br><br>
Chung et al. in a recently published study compared the long-term clinical and echocardiographic outcomes of 294 patients who underwent mitral valvuloplasty for degenerative mitral regurgitation (MR) with either a Carpentier-Edwards (semi-rigid) ring (n=153) or a Duran (flexible) ring (n=141) between 1994 and 2004. Their results showed comparable long-term outcomes in terms of LV function, MR recurrence, survival and reoperation for the two groups with a greater tendency towards mitral stenosis development with the Duran ring, this being most likely due to late pannus formation. <br><br>
Chang et al. in their RCT enrolling 356 patients (Carpentier ring group, n=186; Duran ring group, n=170), with similar demographics, showed similar long-term outcomes as well as left ventricular systolic function measured with echocardiography for the two groups at a mean follow-up of 46.6 months. The 8-year freedom from recurrence of significant MR was 62.6±19.0% in the Carpentier ring group and 55.5±14.1% in the Duran ring group (P=0.172). <br><br>
Shahin et al. in their RCT comparing 96 patients randomised for either a Carpentier-Edwards rigid Classic (n=53) or a semi-flexible Physio (n=43) ring reported no differences in morbidity, valve function, and left ventricular function at a mean follow-up of 5.1 years. <br><br>
Bevilacqua et al. in a retrospective study of 133 patients, of whom 77 patients (57.9%) received a Carpentier-Edwards ring and 56 received (42.1%) an autologous pericardium ring, showed that 5-year freedom from reoperation and recurrence of mitral regurgitation 3+/4+ was significantly higher in the prosthetic ring group (90.1% – CL90%: 81.9–98.3%) compared with the pericardial ring group (62.6% – CL90%: 43.1–82.1%; P=0.027). The results of this study contradicted the results of an earlier small retrospective study by Milano et al. which compared four different annuloplasty techniques in 62 patients: local posterior annuloplasty (group 1, n=10), rigid Carpentier ring (group 2, n=20), Duran ring (group 3, n=17), and posterior annular plication with autologous pericardium (group 4, n=15). Mean follow-up in the entire patient series was 31±12 months. One patient in group two required reoperation 14 months after MV repair. In all groups there was a significant improvement in NYHA functional class (from 2.7±0.6 to 0.9±0.5, P<0.001), with a reduction of left ventricular end-diastolic and end-systolic volumes (154±50 ml to 105±33 ml, P<0.001; and 64±23 ml to 52±22 ml, P<0.001). In patients of groups 2, 3 and 4, residual mitral incompetence at follow-up (0.8±0.9 in group 2, 0.8±0.7 in group 3, and 0.2±0.6 in group 4) was not significantly different from discharge. However, in group 1, a higher degree of residual mitral regurgitation was present at discharge (0.9±0.6) with a trend to progress at follow-up (1.6±0.5). The results of this study prompted the authors to conclude that autologous pericardium appears to be an excellent annuloplasty material.
Bottom Line:
Current best available evidence suggests that in patients with a flexible annuloplasty ring compared to patients with a semi-rigid/rigid annuloplasty ring the improvement in LV systolic function reported by sophisticated echocardiographic studies does not translate into better clinical outcomes as clinical studies, including two RCTs, report comparable outcomes for patients with mitral regurgitation secondary to degenerative mitral valve disease requiring mitral valve repair with an annuloplasty ring.
References:
  1. Borghetti V, Campana M, Scotti C et al.. Biological versus prosthetic ring in mitral-valve repair: enhancement of mitral annulus dynamics and left-ventricular function with pericardial annuloplasty at long-term.
  2. Dall'Agata A, Taams MA, Fioretti PM et al.. Cosgrove-Edwards mitral ring dynamics measured with transesophageal three-dimensional echocardiography.
  3. Yamaura Y, Yoshida K, Hozumi T et al.. Three-dimensional echocardiographic evaluation of configuration and dynamics of the mitral annulus in patients fitted with an annuloplasty ring.
  4. Okada Y, Shomura T, Yamaura Y et al.. Comparison of the Carpentier and Duran prosthetic rings used in mitral reconstruction.
  5. Yamaura Y, Yoshikawa J, Yoshida K et al.. Three-dimensional analysis of configuration and dynamics in patients with an annuloplasty ring by multiplane transesophageal echocardiography: comparison between flexible and rigid annuloplasty rings.
  6. Unger-Graeber B, Lee RT, Sutton MS et al.. Doppler echocardiographic comparison of the Carpentier and Duran anuloplasty rings versus no ring after mitral valve repair for mitral regurgitation.
  7. David TE, Komeda M, Pollick C et al.. Mitral valve annuloplasty: the effect of the type on left ventricular function.
  8. Chung CH, Kim JB, Choo SJ, et al.. Long-term outcomes after mitral ring annuloplasty for degenerative mitral regurgitation: Duran ring versus Carpentier-Edwards ring.
  9. Chang BC, Youn YN, Ha JW et al.. Long-term clinical results of mitral valvuloplasty using flexible and rigid rings: a prospective and randomized study.
  10. Shahin GM, van der Heijden GJ, Bots ML et al.. The Carpentier-Edwards Classic and Physio mitral annuloplasty rings: a randomized trial.
  11. Bevilacqua S, Cerillo AG, Gianetti J et al.. Mitral valve repair for degenerative disease: is pericardial posterior annuloplasty a durable option.
  12. Milano A, Codecasa R, De Carlo M et al.. Mitral valve annuloplasty for degenerative disease: assessment of four different techniques.