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The Carpentier-Edwards Classic and Physio mitral annuloplasty rings: a randomized trial
Ghada M M Shahin1, Geert J M G van der Heijden, Michiel L Bots
1Department of Cardio-thoracic Surgery, Sint Antonius Hospital Nieuwegein, Heart Lung Center Utrecht, Utrecht, The Netherlands.
Insights
The semi-flexible Carpentier-Edwards Physio ring showed a clinically important, though not statistically significant, reduction in mortality compared to the rigid Classic mitral annuloplasty ring. No significant differences in morbidity or ventricular function were observed between the two rings.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Clinical Outcomes Research
Background:
- Mitral annuloplasty is a key procedure for mitral valve repair.
- The choice between semi-flexible and rigid annuloplasty rings may impact patient outcomes.
- Evaluating long-term clinical and echocardiographic results is crucial for surgical decision-making.
Purpose of the Study:
- To compare the clinical and echocardiographic outcomes of the Carpentier-Edwards Physio (semi-flexible) and Classic (rigid) mitral annuloplasty rings.
- To assess the impact of ring flexibility on mortality, morbidity, and cardiac function.
Main Methods:
- A randomized trial involving 96 patients comparing the Classic (n=53) and Physio (n=43) rings.
- Follow-up averaged 5.1 years, with echocardiography performed in 74% of survivors.
- Statistical analyses were adjusted for baseline characteristics, age, and gender.
Main Results:
- A 16% difference in mortality was observed (14% Physio vs. 30% Classic), considered clinically significant but not statistically significant (P=.41).
- Absolute risk of death after 30 months was lower with the Physio ring.
- No significant differences were found in intra-operative or late repair failure rates, valve function, or left ventricular function (ejection fraction).
Conclusions:
- The observed mortality difference suggests a potential clinical benefit of the semi-flexible Physio ring over the rigid Classic ring.
- No significant differences in morbidity or cardiac function were detected between the two annuloplasty rings.
- Further investigation is warranted to elucidate the reasons behind the observed mortality difference.
Objective:
To evaluate clinical and echocardiographic outcomes for the semi-flexible Carpentier-Edwards Physio and the rigid Classic mitral annuloplasty ring.
Methods:
Ninety-six patients were randomized for either a Classic (n = 53) or a Physio (n = 43) ring from October 1995 through July 1997. Mean follow-up was 5.1 years (range .1-6.6). We included standard patient characteristics at baseline and during follow-up. Analyses were adjusted for age and gender, and for factors that differed across groups at baseline. In 2002, echocardiography was performed in 74% of the survivors.
Results:
We found a 16% difference in mortality: 14% in the Physio group (n = 6) and 30% in the Classic group (n = 16) (adjusted P = .41). Life table analysis shows that the absolute risk of death after 30 months is lower in the Physio group. Intra-operative repair failure occurred in 3 patients (6%) of the Classic group, and in 4 (9%) of the Physio group, resulting in mitral valve replacement. Late failure occurred in 1 patient (2%) in the Classic group, and in 4 (9%) in the Physio group. At follow-up, left ventricular function did not differ across groups (ejection fraction 45% and 48% (adjusted P = .65)). The combined NYHA class III-IV had improved for the Classic group in 42% and for the Physio group in 34%.
Conclusion:
Although the 16% difference in mortality did not reach statistical significance, it is considered clinically important. No differences in morbidity, valve function, and left ventricular function were found. Further research to explain the difference in mortality is required.
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