New Info for Women on Valve Choices

[Guest]

This study was only done on women with rheumatic disease but the results can probably be extrapolated to others.

Mitral mechanical replacement in young rheumatic women: Analysis of long-term survival, valve-related complications, and pregnancy outcomes over a 3707-patient-year follow-up.

J Thorac Cardiovasc Surg. 2005 Jul;130(1):13-9.

De Santo LS, Romano G, Della Corte A, Tizzano F, Petraio A, Amarelli C, De Feo M, Dialetto G, Scardone M, Cotrufo M.

Objective A follow-up study was performed to assess long-term survival, valve-related complications, and pregnancy outcomes in young rheumatic women undergoing isolated mitral mechanical replacement. The influence of prosthetic type on outcomes was also investigated. Methods Between 1975 and 2003, 267 isolated mitral mechanical prostheses were implanted. Follow-up reached 3707.8 patient-years. Results Actuarial survival at 1, 5, 10, 15, 20, and 25 years was 97% +/- 0.01%, 90.4% +/- 0.017%, 85.3% +/- 0.023%, 82.3% +/- 0.025%, 71.7% +/- 0.036%, and 70.2% +/- 0.038%, respectively. At multivariate analysis, atrial fibrillation at follow-up was identified as an independent risk factor for late mortality, whereas left ventricular ejection fraction at 12 postoperative months proved to be a protective factor. Freedom from thromboembolism at 1, 5, 10, 15, 20, and 25 years was 98.1% +/- 0.01%, 94.1% +/- 0.015%, 89.1% +/- 0.021%, 85.9% +/- 0.025%, 81.1% +/- 0.031%, and 75.3% +/- 0.063%, respectively. Atrial fibrillation and Carbomedics device were significantly associated with an increase in thromboembolic events. Freedom from reoperation at 1, 5, 10, 15, 20, and 25 years was 99.2% +/- 0.005%, 95% +/- 0.014%, 91.6% +/- 0.018%, 88.6% +/- 0.022%, and 85.7% +/- 0.041%. Type of prosthesis (tilting disc) was identified as a predictor of reoperation. At the end of the study, 208 patients were still alive: 94.7% were in New York Heart Association class I or II. When receiving warfarin therapy, no patient undertaking pregnancy (n = 35) experienced adverse cardiac or valve-related events. Fetal events were significantly less frequent with a daily warfarin dose less than 5 mg. Conclusions Mechanical devices provided excellent performance, safety, and durability. The prognostic role of left ventricular function and atrial fibrillation overwhelmed any differences that might exist between different prosthetic designs. Pregnancies entail virtually no maternal risk and predictable fetal complications.

 

[catwoman]

Al:

Very interesting. Seems to offer more hope for women with mechanicals & taking less than 5mg of warfarin who want to become pregnant, if I understood it correctly.
Wonder if valves manufactured more recently have yielded even better results? I'm sure that's impossible to determine.

What about the 59 who died? Any cause(s) of death? No doubt that some deaths were from other disease, auto accidents, etc.

 

[Debrinha GT]

Sounds interesting, but...

Sounds interesting, but...

Dear Al, I read some of the article you've posted but since I'm a bit slow in understanding all this thing about statistics, I'd appreciate it if you could tell me in simple English, but in detail, if and where I fit into it. As you know I've had three mitral valve replacements with tissue valves as a result of rheumatic fever at the age of seven. My first two valves were dura-mater and the third, bovine. Thanks in advance.
Débora

 

[Guest]

They followed 267 women with rheumatic heart disease who had mitral valves put in between 1975 and 2003. Because of this long time there will be a lot of variability in the quality of the valves so you should read this as being sort of a worst case example. There were 3708 patient-years of follow-up. This is huge so the results will reflect a lot of real-world stuff not just controlled circumstances that could be done on shorter-term studies. The study was done in Italy where they have all health records as government records. This makes it less likely to lose someone because they moved or went to a different doctor.

1 year after surgery 97% were alive
5 years - 90% were alive
10 years - 85%
15 years 82%
20 years 72%
25 years 70%

After 1 year 2% had a blood clot - probably a stroke
5 years 6%
10 years 11%
15 years 14%
20 years 19%
25 years 25%
(Remember that this study started in 1975 and warfarin wasn't well managed until about 1990)

People who had atrial fibrillation had an increased risk of strokes (this is to be expected). Carbomedics valves had a higher risk of clots. (This may not be true today.)

The reoperation data is probably not too important for people anticipating surgery today because the leading risk factor for reoperation was the old fashioned tilting disc valve. Nobody gets these any more.

No data was given on why people died. NYHA Class I or II is excellent to very good health. 95% of the people who survived were in this class.

There were 35 pregnancies - none caused valve problems. There were fewer problems in children whose mothers required 5 mg of warfarin daily or less. (Several of these authors reported this about 5 years ago.) We know that pregnancy presents somewhat of a dilemma because warfrain is better for the mother and heparin is better for the baby.

How well the left ventricle performed after surgery and whether or not the person developed atrial fibrillation were more powerful predictors of bad outcomesthat the type of valve that was chosen.

 

[bvdr]

Al, I would love to read the whole article. Is it available on the web?

 

[KMB]

I agree this article was very helpful in providing insight for those of us with mechanical valves and want children.
Thanks AL

 

[Guest]

Unfortunately, this article provided nothing new about pregnancy while on warfarin. The information was restating what these people published about 5 years ago. If you asked about the topic and were told that you could not have children on warfarin then you were getting bad information. I have a page about this on my website http://warfarinfo.com/pregnancy.htm

The article might be on the web but it probably has a high fee for reading it. Try copying the first post and having a librarian get it for you.

Nothing about aortic valves. Mitral are more troublesome. Mitral are damaged by rheumatic fever and this was what they set out to study many years ago.