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1: Tex Heart Inst J. 2006;33(2):154-9.
St. Jude Medical and CarboMedics mechanical heart valves in the aortic position: comparison of long-term results.
Kandemir O, Tokmakoglu H, Yildiz U, Tezcaner T, Yorgancioglu AC, Gunay L, Suzer K, Zorlutuna Y.
Department of Cardiovascular Surgery, Bayindir Hospital, Ankara, Turkey. [email protected]
We designed this study to compare long-term results of St. Jude Medical and CarboMedics mechanical heart valves in the aortic position. We retrospectively analyzed the results of 174 consecutive patients who received either a St. Jude (n=80) or a CarboMedics (n=94) mechanical aortic valve from March 1992 through October 2004. The follow-up rate was 97.7%. The mean follow-up duration for the St. Jude group was 79.3 +/- 35.0 and for the CarboMedics group, 70.0 +/- 34.3 months. The cumulative follow-up was 523.8 and 530.1 patient-years, respectively The 30-day mortality rates for the St. Jude and CarboMedics patients were 1.3% and 3.2%, respectively. The actuarial survival rate for the St. Jude group at 138.0 +/- 4.7 months was 75.9% +/- 0.1% and for the CarboMedics group at 130.8 +/- 4.8 months was 69.8% +/- 0.1% (P=NS). There was no structural valve deterioration in either group. Freedom from thromboembolic events was 87.7% for the St. Jude group and 83.0% for the CarboMedics group (P=NS). Freedom from bleeding events for the St. Jude group was 93.6% and for the CarboMedics group, 89.7% (P=NS). The results obtained from this study indicate that standard St. Jude Medical and CarboMedics aortic valve prostheses offer similar excellent clinical performance. Definitive judgment must await trials that are extensive, randomized, and prospective.
PMID: 16878617 [PubMed - indexed for MEDLINE]
Turkey seems to have a lot of doctors doing research on mechanical valves.
In the write-up the abbreviation P=NS means that there was not a statistically significant difference. Roughly this means that if you flipped a coin for each comparison you might get this much variation between heads and tails -- this is just as likely to be due to pure chance as anything else.
The authors say that definitive judgement on which aortic valve is better must await trials that are extensive, randomized and prospective. Well don't delay your decision waiting for these. There might not be that type of information available for many years. A prospective trial means that the participants are randomly assigned to groups before the trial starts. So if one started today it could be another 14 years before the results are reported. Of course, one that we don't know about could be published Monday -- we just don't know.
This trial had over 500 patient-years in each group. This gives it a lot of weight. If I were going to bet, I'd say that it is unlikely that a more definitive trial will find any significance either.
St. Jude Medical and CarboMedics mechanical heart valves in the aortic position: comparison of long-term results.
Kandemir O, Tokmakoglu H, Yildiz U, Tezcaner T, Yorgancioglu AC, Gunay L, Suzer K, Zorlutuna Y.
Department of Cardiovascular Surgery, Bayindir Hospital, Ankara, Turkey. [email protected]
We designed this study to compare long-term results of St. Jude Medical and CarboMedics mechanical heart valves in the aortic position. We retrospectively analyzed the results of 174 consecutive patients who received either a St. Jude (n=80) or a CarboMedics (n=94) mechanical aortic valve from March 1992 through October 2004. The follow-up rate was 97.7%. The mean follow-up duration for the St. Jude group was 79.3 +/- 35.0 and for the CarboMedics group, 70.0 +/- 34.3 months. The cumulative follow-up was 523.8 and 530.1 patient-years, respectively The 30-day mortality rates for the St. Jude and CarboMedics patients were 1.3% and 3.2%, respectively. The actuarial survival rate for the St. Jude group at 138.0 +/- 4.7 months was 75.9% +/- 0.1% and for the CarboMedics group at 130.8 +/- 4.8 months was 69.8% +/- 0.1% (P=NS). There was no structural valve deterioration in either group. Freedom from thromboembolic events was 87.7% for the St. Jude group and 83.0% for the CarboMedics group (P=NS). Freedom from bleeding events for the St. Jude group was 93.6% and for the CarboMedics group, 89.7% (P=NS). The results obtained from this study indicate that standard St. Jude Medical and CarboMedics aortic valve prostheses offer similar excellent clinical performance. Definitive judgment must await trials that are extensive, randomized, and prospective.
PMID: 16878617 [PubMed - indexed for MEDLINE]
Turkey seems to have a lot of doctors doing research on mechanical valves.
In the write-up the abbreviation P=NS means that there was not a statistically significant difference. Roughly this means that if you flipped a coin for each comparison you might get this much variation between heads and tails -- this is just as likely to be due to pure chance as anything else.
The authors say that definitive judgement on which aortic valve is better must await trials that are extensive, randomized and prospective. Well don't delay your decision waiting for these. There might not be that type of information available for many years. A prospective trial means that the participants are randomly assigned to groups before the trial starts. So if one started today it could be another 14 years before the results are reported. Of course, one that we don't know about could be published Monday -- we just don't know.
This trial had over 500 patient-years in each group. This gives it a lot of weight. If I were going to bet, I'd say that it is unlikely that a more definitive trial will find any significance either.
