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. 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. 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. 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.
Subject(s)
Aortic Valve/surgery , Heart Valve Diseases/surgery , Heart Valve Prosthesis Implantation/methods , Sternotomy/methods , 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 OutcomeABSTRACT
BACKGROUND: Spinal cord stimulation (SCS) and percutaneous myocardial laser revascularisation (PMR) are treatment modalities used to treat refractory angina pectoris, with the major aim of such treatment being the relief of disabling symptoms. This study compared the change in myocardial perfusion following SCS and PMR treatment. METHODS: Subjects with Canadian Cardiovascular Society class 3/4 angina and reversible perfusion defects as assessed by single-photon emission computed tomographic myocardial perfusion scintigraphy were randomised to SCS (34) or PMR (34). Twenty-eight subjects in each group underwent repeat myocardial perfusion imaging 12 months post intervention. Visual scoring of perfusion images was performed using a 20-segment model and a scale of 0 to 4. RESULTS: The mean (standard deviation) baseline summed rest score (SRS) and stress scores (SSS) were 4.6 (5.7) and 13.6 (9.0) in the PMR group and 6.1 (7.4) and 16.8 (11.6) in the SCS group. At 12 months, SRS was 5.5 (6.0) and SSS 15.3 (11.3) in the PMR group and 6.9 (8.2) and 15.1 (10.9) in the SCS group. There was no significant difference between the two treatment groups adjusted for baseline (p = 1.0 for SRS, p = 0.29 for SSS). CONCLUSION: There was no significant difference in myocardial perfusion one year post treatment with SCS or PMR.