Mini-Stern Trial: A randomised trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K. Nair; Catherine D. Sudarshan; Benjamin S. Thorpe; Jeshika Singh; Thasee Pillay; Pedro Catarino; Kamen Valchanov; Massimiliano Codispoti; John Dunning; Yasir Abu-Omar; Narain Moorjani; Claire Matthews; Carol J. Freeman; Julia A. Fox-Rushby; Linda D. Sharples

doi:10.1016/j.jtcvs.2018.05.057

Mini-Stern Trial: A randomised trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Sukumaran K. Nair, Catherine D. Sudarshan, Benjamin S. Thorpe, Jeshika Singh, Thasee Pillay, Pedro Catarino, Kamen Valchanov, Massimiliano Codispoti, John Dunning, Yasir Abu-Omar, Narain Moorjani, Claire Matthews, Carol J. Freeman, Julia A. Fox-Rushby, Linda D. Sharples

Population Health Sciences

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50 Citations (Scopus)

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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 RCT compared MS with FS for first-time isolated AVR in two UK NHS hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analysed in the intent-to-treat population.

Results

In this RCT, 222 patients were recruited and randomised (118 MS, 104 FS). Compared to FS patients, MS patients had longer hospital stay (mean 9.5 vs. 8.6 days) and took longer to achieve fitness for discharge home (mean 8.5 vs. 7.5 days). Adjusting for valve type, sex and surgeon, hazard ratios (HR) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0.874, 95% CI 0.668-1.143, p-value 0.3246) or time to fitness for discharge (HR 0.907, 95% CI 0.688-1.197, p-value 0.4914). During mean follow up of 760 days (MS:745 and FS:777 days), 12 (10%) MS and 7 (7%) FS patients died (HR 1.871, 95% CI 0.723-4.844, p-value 0.1966). Average extra cost for MS was £1,714, during the first 12 months after AVR. Conclusions Compared to FS for AVR, MS did not result in shorter hospital stay, faster recovery or improved survival and was not cost-effective. MS approach is not superior to FS for performing AVR.

Original language	English
Journal	Journal of Thoracic and Cardiovascular Surgery
Early online date	4 Jun 2018
DOIs	https://doi.org/10.1016/j.jtcvs.2018.05.057
Publication status	E-pub ahead of print - 4 Jun 2018

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10.1016/j.jtcvs.2018.05.057

Mini-Stern Trial A_NAIR_Firstonline4June2018_GREEN AAM (CC BY-NC-ND)Accepted author manuscript, 16.4 MBLicence: CC BY-NC-ND

50 Citations
1 Report

Randomised controlled trial of a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45-74 years
Harris, T., Kerry, S., Victor, C., Iliffe, S., M, U., Fox-Rushby, J., Whincup, P., Ekelund, U., C, F., Limb, E., Anokye, N., Ibison, J., DeWilde, S., David, L., Howard, E., Dale, R., Smith, J., Normansell, R., Beighton, C. & Morgan, K. & 3 others, Wahlich, C., Sanghera, S. & Cook, D., Jul 2018, 37 ed. Health Technology Assessment . (Health Technology Assessment)
Research output: Book/Report › Report › peer-review

Open Access
24 Citations (Scopus)

Cite this

Nair, S. K., Sudarshan, C. D., Thorpe, B. S., Singh, J., Pillay, T., Catarino, P., Valchanov, K., Codispoti, M., Dunning, J., Abu-Omar, Y., Moorjani, N., Matthews, C., Freeman, C. J., Fox-Rushby, J. A., & Sharples, L. D. (2018). Mini-Stern Trial: A randomised trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement. Journal of Thoracic and Cardiovascular Surgery. Advance online publication. https://doi.org/10.1016/j.jtcvs.2018.05.057

@article{5d8cf10f3e9f4ff3a62f8eae464c749e,

title = "Mini-Stern Trial: A randomised trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement",

abstract = "ObjectiveAortic 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 RCT compared MS with FS for first-time isolated AVR in two UK NHS hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analysed in the intent-to-treat population. ResultsIn this RCT, 222 patients were recruited and randomised (118 MS, 104 FS). Compared to FS patients, MS patients had longer hospital stay (mean 9.5 vs. 8.6 days) and took longer to achieve fitness for discharge home (mean 8.5 vs. 7.5 days). Adjusting for valve type, sex and surgeon, hazard ratios (HR) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0.874, 95% CI 0.668-1.143, p-value 0.3246) or time to fitness for discharge (HR 0.907, 95% CI 0.688-1.197, p-value 0.4914). During mean follow up of 760 days (MS:745 and FS:777 days), 12 (10%) MS and 7 (7%) FS patients died (HR 1.871, 95% CI 0.723-4.844, p-value 0.1966). Average extra cost for MS was £1,714, during the first 12 months after AVR. Conclusions Compared to FS for AVR, MS did not result in shorter hospital stay, faster recovery or improved survival and was not cost-effective. MS approach is not superior to FS for performing AVR.",

author = "Nair, {Sukumaran K.} and Sudarshan, {Catherine D.} and Thorpe, {Benjamin S.} and Jeshika Singh and Thasee Pillay and Pedro Catarino and Kamen Valchanov and Massimiliano Codispoti and John Dunning and Yasir Abu-Omar and Narain Moorjani and Claire Matthews and Freeman, {Carol J.} and Fox-Rushby, {Julia A.} and Sharples, {Linda D.}",

year = "2018",

month = jun,

day = "4",

doi = "10.1016/j.jtcvs.2018.05.057",

language = "English",

journal = "Journal of Thoracic and Cardiovascular Surgery",

issn = "0022-5223",

publisher = "Elsevier",

}

Nair, SK, Sudarshan, CD, Thorpe, BS, Singh, J, Pillay, T, Catarino, P, Valchanov, K, Codispoti, M, Dunning, J, Abu-Omar, Y, Moorjani, N, Matthews, C, Freeman, CJ, Fox-Rushby, JA & Sharples, LD 2018, 'Mini-Stern Trial: A randomised trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement', Journal of Thoracic and Cardiovascular Surgery. https://doi.org/10.1016/j.jtcvs.2018.05.057

TY - JOUR

T1 - Mini-Stern Trial

T2 - A randomised trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

AU - Nair, Sukumaran K.

AU - Sudarshan, Catherine D.

AU - Thorpe, Benjamin S.

AU - Singh, Jeshika

AU - Pillay, Thasee

AU - Catarino, Pedro

AU - Valchanov, Kamen

AU - Codispoti, Massimiliano

AU - Dunning, John

AU - Abu-Omar, Yasir

AU - Moorjani, Narain

AU - Matthews, Claire

AU - Freeman, Carol J.

AU - Fox-Rushby, Julia A.

AU - Sharples, Linda D.

PY - 2018/6/4

Y1 - 2018/6/4

N2 - ObjectiveAortic 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 RCT compared MS with FS for first-time isolated AVR in two UK NHS hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analysed in the intent-to-treat population. ResultsIn this RCT, 222 patients were recruited and randomised (118 MS, 104 FS). Compared to FS patients, MS patients had longer hospital stay (mean 9.5 vs. 8.6 days) and took longer to achieve fitness for discharge home (mean 8.5 vs. 7.5 days). Adjusting for valve type, sex and surgeon, hazard ratios (HR) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0.874, 95% CI 0.668-1.143, p-value 0.3246) or time to fitness for discharge (HR 0.907, 95% CI 0.688-1.197, p-value 0.4914). During mean follow up of 760 days (MS:745 and FS:777 days), 12 (10%) MS and 7 (7%) FS patients died (HR 1.871, 95% CI 0.723-4.844, p-value 0.1966). Average extra cost for MS was £1,714, during the first 12 months after AVR. Conclusions Compared to FS for AVR, MS did not result in shorter hospital stay, faster recovery or improved survival and was not cost-effective. MS approach is not superior to FS for performing AVR.

AB - ObjectiveAortic 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 RCT compared MS with FS for first-time isolated AVR in two UK NHS hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analysed in the intent-to-treat population. ResultsIn this RCT, 222 patients were recruited and randomised (118 MS, 104 FS). Compared to FS patients, MS patients had longer hospital stay (mean 9.5 vs. 8.6 days) and took longer to achieve fitness for discharge home (mean 8.5 vs. 7.5 days). Adjusting for valve type, sex and surgeon, hazard ratios (HR) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR 0.874, 95% CI 0.668-1.143, p-value 0.3246) or time to fitness for discharge (HR 0.907, 95% CI 0.688-1.197, p-value 0.4914). During mean follow up of 760 days (MS:745 and FS:777 days), 12 (10%) MS and 7 (7%) FS patients died (HR 1.871, 95% CI 0.723-4.844, p-value 0.1966). Average extra cost for MS was £1,714, during the first 12 months after AVR. Conclusions Compared to FS for AVR, MS did not result in shorter hospital stay, faster recovery or improved survival and was not cost-effective. MS approach is not superior to FS for performing AVR.

U2 - 10.1016/j.jtcvs.2018.05.057

DO - 10.1016/j.jtcvs.2018.05.057

M3 - Article

SN - 0022-5223

JO - Journal of Thoracic and Cardiovascular Surgery

JF - Journal of Thoracic and Cardiovascular Surgery

ER -

Mini-Stern Trial: A randomised trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement

Abstract

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Research output

Randomised controlled trial of a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45-74 years

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