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Mini-Stern Trial: A randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement.
- Source :
-
The Journal of thoracic and cardiovascular surgery [J Thorac Cardiovasc Surg] 2018 Dec; Vol. 156 (6), pp. 2124-2132.e31. Date of Electronic Publication: 2018 Jun 04. - Publication Year :
- 2018
-
Abstract
- Objective: Aortic valve replacement (AVR) can be performed either through full median sternotomy (FS) or upper mini-sternotomy (MS). The Mini-Stern trial aimed to establish whether MS leads to quicker postoperative recovery and shorter hospital stay after first-time isolated AVR.<br />Methods: This pragmatic, open-label, parallel randomized controlled trial (RCT) compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analyzed in the intent-to-treat population.<br />Results: In this RCT, 222 patients were recruited and randomized (n = 118 in the MS group; n = 104 in the FS group). Compared with the FS group, the MS group had a longer hospital length of stay (mean, 9.5 days vs 8.6 days) and took longer to achieve fitness for discharge home (mean, 8.5 days vs 7.5 days). Adjusting for valve type, sex, and surgeon, hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR, 0.874; 95% confidence interval [CI], 0.668-1.143; P = .3246) or time to fitness for discharge (HR, 0.907; 95% CI, 0.688-1.197; P value = .4914). During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group), 12 patients (10%) in the MS group and 7 patients (7%) in the FS group died (HR, 1.871; 95% CI, 0.723-4.844; P = .1966). Average extra cost for MS was £1714 during the first 12 months after AVR.<br />Conclusions: Compared with FS for AVR, MS did not result in shorter hospital stay, faster recovery, or improved survival and was not cost-effective. The MS approach is not superior to FS for performing AVR.<br /> (Copyright © 2018 The American Association for Thoracic Surgery. All rights reserved.)
- Subjects :
- Aged
Aged, 80 and over
Aortic Valve diagnostic imaging
Aortic Valve physiopathology
Cost-Benefit Analysis
England
Female
Heart Valve Diseases diagnostic imaging
Heart Valve Diseases physiopathology
Heart Valve Prosthesis Implantation adverse effects
Heart Valve Prosthesis Implantation economics
Hospital Costs
Humans
Length of Stay
Male
Middle Aged
Patient Discharge
Recovery of Function
Sternotomy adverse effects
Sternotomy economics
Time Factors
Treatment Outcome
Aortic Valve surgery
Heart Valve Diseases surgery
Heart Valve Prosthesis Implantation methods
Sternotomy methods
Subjects
Details
- Language :
- English
- ISSN :
- 1097-685X
- Volume :
- 156
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- The Journal of thoracic and cardiovascular surgery
- Publication Type :
- Academic Journal
- Accession number :
- 30075959
- Full Text :
- https://doi.org/10.1016/j.jtcvs.2018.05.057