I believe that this is the world’s first randomized controlled trial of mini aortic valve replacement (AVR) versus full sternotomy AVR.
It is a very well-conducted study where the surgeon was randomly assigned to perform an AVR by sterntomy or by manubrium-only. The same consultant surgeon performed either operation after randomization. No trainee performed any operations as operating surgeon. The protocol was very tightly adhered to.
The primary outcome was red cell transfusion at 7 days, and there were many secondary outcomes including length of stay, complications, etc, as might be expected.
The mean age was 69 and the mean EuroSCORE was 5.2 and the groups were perfectly matched.
The bypass time was 82 minutes in the ministernotomy group and 59 minutes in the sternotomy group.
The major outcome results might surprise you! Click on the link to find out!
You are here:
World’s First Randomized Study of Mini-Sternotomy AVR Versus Conventional AVR: 271 Patients and the Results Might Surprise You
Submitted by: Joel Dunning
Source: Journal of the American College of Cardiology
Source URL: http://www.onlinejacc.org/content/73/19/2491
Keywords:
Author(s): Helen C. Hancock, Rebecca H. Maier, Adetayo S. Kasim, James M. Mason, Gavin J. Murphy, Andrew T. Goodwin, W. Andrew Owens, Bilal H. Kirmani, Enoch F. Akowuah
5 Comments
I should perhaps correct the ‘first in the world’ claim. It is the first manubrium only mini sternotomy RCT but there has been a very good RCT called the mini-stern Trial published in the JTCVS (June 2018) By S Nair et al who randomized 222 patients to mini sternotomy versus full sternotomy. The mini sternotomy group had a longer length of hospital stay (9.5 days versus 8.6days) and the operation was an average £1714 more expensive.
Recent NEJM articles by Drs. Mack and Popma lay out the future role (or lack of a future) of open AVR in low-risk patients with severe AS and it has nothing to do with the operative approach. Debates over exposure are mindful of “rearranging the chairs on the deck of the Titanic.”
Further to the comments of Mr. Joel Dunning, authors should check the following article published in The Annals of Thoracic Surgery:
Aris A, Cámara ML, Montiel J, Delgado LJ, Galán J, Litvan H. Ministernotomy versus median sternotomy for aortic valve replacement: a prospective, randomized study. Ann Thorac Surg 1999; 67:1583-7; discussion 1587-8.
This was published 20 years ago, and although People may argue about the sample size, it is likely that this was the first RCT on this Topic. Self-attribution of the “World’s first” or something like this, usually happens when full Investigation has not been performed.
Good Trial but better write the Journal for retraction of the “World’s first”
And more. The following study was also published in The Annals of Thoracic Surgery in 2002:
Bonacchi M, Prifti E, Giunti G, Frati G, Sani G. Does ministernotomy improve postoperative outcome in aortic valve operation? A prospective randomized study. Ann Thorac Surg 2002; 73:460-5; discussion 465-6.
In this study, authors enrolled 80 patients.
Dear joel, thank you for this interesting but underpowered study. As a non acedemic surgeon who has been in practise for 24 years, i would like to give you my own anecdotal experience. I was an early adopter of the minimaly invasive approach which included right second interspace or manubrial split with a right lateral extension into the third interspace . I always performed a ct scan of the chest to see exactly where the heart lay in relation to the sternum. My results were comparable to to my full sternotomy results except for one where I had caused a small peimembranous vsd. This was an exceptionaly healthy young man who went to the cleveland clinic for an Anplatz repair of his vsd. After that, I was finished with miniavr?