Comparing quality of life and postoperative pain after limited access and conventional aortic valve replacement: Design and rationale of the LImited access aortic valve replacement (LIAR) trial

Idserd D G Klop, Bart P van Putte, Geoffrey T L Kloppenburg, Mirjam A G Sprangers, Pythia T Nieuwkerk, Patrick Klein, Idserd D G Klop, Bart P van Putte, Geoffrey T L Kloppenburg, Mirjam A G Sprangers, Pythia T Nieuwkerk, Patrick Klein

Abstract

Background: Surgical aortic valve replacement (SAVR) via limited access approaches ('mini-AVR') have proven to be safe alternative for the surgical treatment of aortic valve disease. However, it remains unclear whether these less invasive approaches are associated with improved quality of life and/or reduced postoperative pain when compared to conventional SAVR via full median sternotomy (FMS).

Study design: The LImited access Aortic valve Replacement (LIAR) trial is a single-center, single blind randomized controlled clinical trial comparing 2 arms of 80 patients undergoing limited access SAVR via J-shaped upper hemi-sternotomy (UHS) or conventional SAVR through FMS. In all randomized patients, the diseased native aortic valve is planned to be replaced with a rapid deployment stented bioprosthesis. Patients unwilling or unable to participate in the randomized trial will be treated conventionally via SAVR via FMS and with implantation of a sutured valve prosthesis. These patients will participate in a prospective registry.

Study methods: Primary outcome is improvement in cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire up to one year after surgery. Secondary outcomes include, but are not limited to: generic quality of life measured with the Short Form-36, postoperative pain, perioperative (technical success rate, operating time) and postoperative outcomes (30-day and one-year mortality), complication rate and hospital length of stay.

Conclusion: The LIAR trial is designed to determine whether a limited access approach for SAVR ('mini-AVR') is associated with improved quality of life and/or reduced postoperative pain compared with conventional SAVR through FMS.The study is registered at ClinicalTrials.gov, number NCT04012060.

Keywords: Limited access; Mini-AVR; Patient reported outcome measures; Randomized controlled trial; Surgical aortic valve replacement; Upper hemi-sternotomy.

Conflict of interest statement

Patrick Klein is consultant to Edwards Lifesciences and proctor for the EDWARDS INTUITY ELITE valve system.

© 2021 Published by Elsevier Inc.

References

    1. Nkomo V.T., Gardin J.M., Skelton T.N., Gottdiener J.S., Scott C.G., Enriquez-Sarano M. Burden of valvular heart diseases: a population based study. Lancet. 2006 Sep 16;368(9540):1005–1011.
    1. Baumgartner H., Falk V., Bax J.J., De Bonis M., Hamm C., Holm P.J. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur. Heart J. 2017
    1. Brown M.L., McKellar S.H., Sundt T.M., Schaff H.F. Ministernotomy versus conventional sternotomy for aortic valve replacement: a systematic review and meta-analysis. J. Thorac. Cardiovasc. Surg. 2009 Mar;137(3):670–679.
    1. Cosgrove D.M., Sabik J.F. Minimally invasive approach for aortic valve operations. Ann. Thorac. Surg. 1996 Aug;62(2):596–597.
    1. Glauber M., Ferrarini M., Miceli A. Minimally invasive aortic valve surgery: state of the art and future directions. Ann. Cardiothorac. Surg. 2015 Jan;4(1):26–32.
    1. Borger M.A., Moustafine V., Conradi L., Knosalla C., Richter M., Merk D.R. A randomized multicenter trial of minimally invasive rapid deployment versus conventional full sternotomy aortic valve replacement. Ann. Thorac. Surg. 2015 Jan;99(1):17–25.
    1. 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 Feb;73(2):460–465.
    1. Dogan S., Dzemali O., Wimmer-Greinecker G., Derra P., Doss M., Khan M.F. Minimally invasive versus conventional aortic valve replacement: a prospective randomized trial. J. Heart Valve Dis. 2003 Jan;12(1):76–80.
    1. Mächler H.E., Bergmann P., Anelli-Monti M., Dacar D., Rehak P., Knez I. Minimally invasive versus conventional aortic valve operations: a prospective study in 120 patients. Ann. Thorac. Surg. 1999 Apr;67(4):1001–1005.
    1. Phan K., Xie A., Di Eusanio M., Yan T.D. A meta-analysis of minimally invasive versus conventional sternotomy for aortic valve replacement. Ann. Thorac. Surg. 2014 Oct;98(4):1499–1511.
    1. Murtuza B., Pepper J.R., Stanbridge R.D., Jones C., Rao C., Darzi A. Minimal access aortic valve replacement: is it worth it? Ann. Thorac. Surg. 2008 Mar;85(3):1121–1131.
    1. Kirmani B.H., Jones S.G., Malaisrie S.C., Chung D.A., Williams R.J. Limited versus full sternotomy for aortic valve replacement. Cochrane Database Syst. Rev. 2017 Apr 10:4.
    1. Nair S.K., Sudarshan C.D., Thorpe B.S., Singh J., Pillay T., Catarino P. Mini-Stern Trial: a randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement. J. Thorac. Cardiovasc. Surg. 2018 Dec;156(6):2124–2132.
    1. Dalen M., Biancari F., Rubino A.S., Santarpino G., De Praetere H., Kasama K. Ministernotomy versus full sternotomy aortic valve replacement with a sutureless bioprosthesis: a multicenter study. Ann. Thorac. Surg. 2015;99(2):524–530.
    1. Hancock H.C., Maier R.H., Kasim A.S., Mason J.M., Murphu G.J., Goodwin A.T. Mini-sternotomy versus conventional sternotomy for aortic valve replacement. J. Am. Coll. Cardiol. 2019 May 21;73(19):2491–2492.
    1. Merk D.R., Lehmann S., Holzhey D.M., Dohmen P., Candolfi P., Misfeld M. Minimal invasive aortic valve replacement surgery is associated with improved survival: a propensity-matched comparison. Eur. J. Cardio. Thorac. Surg. 2015 Jan;47(1):11–17. discussion 17.
    1. Kocher A.A., Laufer G., Haverich A., Shresta M., Walther T., Misfeld M. One-year outcomes of the surgical treatment of aortic stenosis with a next generation surgical aortic valve (TRITON) trial: a prospective multicenter study of rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system. J. Thorac. Cardiovasc. Surg. 2013 Jan;145(1):110–115.
    1. Barnhart G.R., Accola K.D., Grossi E.A., Woo Y.J., Mumtaz M.A., Sabik J.F. TRANSFORM (multicenter experience with rapid deployment Edwards INTUITY valve system for aortic valve replacement) US clinical trial: performance of a rapid deployment aortic valve. J. Thorac. Cardiovasc. Surg. 2017 Feb;153(2):241–251.
    1. Yilmaz A., Sjatskig J., van Boven W.J., Waanders F.G., Kelder J.C., Sonker U. J-shaped versus median sternotomy for aortic valve replacement with minimal extracorporeal circuit. Scand. Cardiovasc. J. 2011 Dec;45(6):379–384.
    1. Noyez L., de Jager M.J., Markou A.L. Quality of life after cardiac surgery: underresearched research. Interact. Cardiovasc. Thorac. Surg. 2011 Nov;13(5):511–514.
    1. Nishimura R.A., Otto C.M., Bonow R.O., Carabello B.A., Erwin J.P., 3rd, Guyton R.A. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American heart association task force members. Circulation. 2014;129:2440–2492.
    1. Harris P.A., Taylor R.M.A., Thielke R.D., Payne J., Gonzalez N., Conde J.G. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J. Biomed. Inf. 2009;42(2):377–381.
    1. Green C.P., Porter C.B., Bresnahan D.R., Spertus J.A. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J. Am. Coll. Cardiol. 2000 Apr;35(5):1245–1255.
    1. Ware J.E., Jr., Sherbourne C.D. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med. Care. 1992 Jun;30(6):473–483.
    1. Price D.D., Bush F.M., Long S., Harkins S.W. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217–226.
    1. Lahtinen P., Kokki H., Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794–800.
    1. Gallagher E.J., Liebman M., Bijur P.E. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann. Emerg. Med. 2001 Dec;38(6):633–638.
    1. Spertus J., Peterson E., Conard M.W., Heidenreich P.A., Krumholz H.M., Jones P. Monitoring clinical changes in patients with heart failure: a comparison of methods. Am. Heart J. 2005 Oct;150(4):707–715.

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