Psoas Muscle Index (PMI) as a Predictor of Outcomes After Minimally Invasive Cardiac Surgery (PsoMICS)

Psoas Muscle Index (PMI) as a Predictor of Mobilisation and Postoperative Length of Stay After Minimally Invasive Cardiac Surgery

Sarcopenia or muscle loss and function is a component of the frailty syndrome. In this sense, frailty is becoming an important risk factor in predicting outcomes after major surgery and is defined as a geriatric syndrome of decreased reserve and resiliency to stressors that have been associated with adverse health outcomes in older adults. Despite its potentially relevant role in predicting postoperative recovery, frailty is rarely evaluated before surgery, and this is partially due to the low reliability of the most used frailty scores. Therefore, improvement in the frailty evaluation would be beneficial during the preoperative assessment of major surgeries. Sarcopenia, or the decline of skeletal muscle tissue with age, is one of the most important causes of functional decline and loss of independence in older adults and low muscle mass is a core component of frailty that has the advantage of being objectively quantifiable regardless of mobility, disability, or illness acuity. Psoas Muscle (PM) mass is an important parameter for evaluating muscle mass and has been previously correlated to frailty with a negative impact on the postoperative outcomes after major surgery and Psoas Muscle mass Index (PMI) is an easily available parameter for evaluating muscle mass and has already been demonstrated to be effective in predicting outcomes in different clinical settings. PMI has also been shown to be an effective predictor of outcomes in cardiac surgery although there are no studies specifically focusing on minimally invasive cardiac surgery. With this study, the investigators aim to investigate the relevance of PMI as a predictor of postoperative mobilisation, hospital length of stay and clinical recovery after major cardiac surgery conducted via a minimally invasive approach.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Valve Diseases; Sarcopenia
• Intervention / Treatment: Other: Lower Abdomen MRI

Detailed Description

This is a prospective, controlled, observational single-centre study of patients undergoing minimally invasive heart valve surgery at the department of minimally invasive cardiac surgery of the IRCCS Galeazzi Sant'Ambrogio Hospital, in Milan (Italy).

The primary endpoint is to evaluate the role of psoas muscle index (PMI) in predicting length of stay and early mobility after heart valve surgery via a minimally invasive approach.

25 consecutive participants patients undergoing minimally invasive cardiac surgery will be assessed with a lower abdomen MRI before the surgery to evaluate the diameter of the psoas muscle and therefore assess the Psoas Muscle Index (PMI). Frailty will be evaluated using the PRISMA-7 questionnaire.

PMI value will be correlated with the main outcomes via regression methods and adjusted for covariates.

The participants will be consented to the study before the cardiac surgery operation (indexed procedure). Surgeries will include aortic, mitral and tricuspid valve operations conducted either via a mini-thoracotomy or a mini-sternotomy approach and every patient will receive routine preoperative, operative and postoperative cardiac surgery care. In addition to standard cardiac surgery clinical variables, the investigators will collect data on:

• Total intubation hours
• Total Intensive Treatment Unit (ITU) length of stay
• Total postoperative length of hospital stay
• Time between end of surgery and first mobilisation (see below)

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Vito D Bruno, MD, PhD; Phone Number: 6748 0283500010; Email: vitodomenico.bruno@grupposandonato.it

Study Locations

• Italy
  • Milan, Italy, 20173
    • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cardiac surgery patients undergoing heart valve surgery via a minimally invasive approach

Description

Inclusion Criteria:

• Elderly patients (≥ 65 years old)
• Able to take consent
• Listed for minimally invasive cardiac surgery
• Elective and urgent procedures included
• Able to undergo MRI

Exclusion Criteria:

• Full median sternotomy approach
• Emergency procedures
• Unable to take consent
• Unable to undergo MRI

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Intensive care unit (ITU) stay	Total number of hours spent in ITU after the primary (indexed) cardiac operation	perioperatively/periprocedurally
Postoperative overall length of stay	Total number of days spent in hospital after the primary (indexed) cardiac operation	perioperatively/periprocedurally
Mobilization time	Time to mobilization after the primary (indexed) cardiac operation defined as standing up or sitting down for at least 3 consecutive hours	perioperatively/periprocedurally

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative mortality	In hospital mortality after the primary (indexed) cardiac operation	perioperatively/periprocedurally
Long term mortality	Mortality at the latest follow up after the primary (indexed) cardiac operation	at 1 year
Postoperative Complications	Any surgical related postoperative complication related to the primary (indexed) cardiac operation	at 30 days

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Publications and helpful links

General Publications

• Raiche M, Hebert R, Dubois MF. PRISMA-7: a case-finding tool to identify older adults with moderate to severe disabilities. Arch Gerontol Geriatr. 2008 Jul-Aug;47(1):9-18. doi: 10.1016/j.archger.2007.06.004. Epub 2007 Aug 27.
• Benedek Z, Todor-Boer S, Kocsis L, Bauer O, Suciu N, Coros MF. Psoas Muscle Index Defined by Computer Tomography Predicts the Presence of Postoperative Complications in Colorectal Cancer Surgery. Medicina (Kaunas). 2021 May 11;57(5):472. doi: 10.3390/medicina57050472.
• Bruno VD, Zakkar M. Psoas muscle index: a novel instrument in planning the treatment of severe aortic stenosis in frail patients. J Thorac Dis. 2018 Nov;10(Suppl 33):S4156-S4158. doi: 10.21037/jtd.2018.10.80. No abstract available.
• Hawkins RB, Mehaffey JH, Charles EJ, Kern JA, Lim DS, Teman NR, Ailawadi G. Psoas Muscle Size Predicts Risk-Adjusted Outcomes After Surgical Aortic Valve Replacement. Ann Thorac Surg. 2018 Jul;106(1):39-45. doi: 10.1016/j.athoracsur.2018.02.010. Epub 2018 Mar 9.
• Mamane S, Mullie L, Piazza N, Martucci G, Morais J, Vigano A, Levental M, Nelson K, Lange R, Afilalo J. Psoas Muscle Area and All-Cause Mortality After Transcatheter Aortic Valve Replacement: The Montreal-Munich Study. Can J Cardiol. 2016 Feb;32(2):177-82. doi: 10.1016/j.cjca.2015.12.002. Epub 2015 Dec 9.
• Okamura H, Kimura N, Tanno K, Mieno M, Matsumoto H, Yamaguchi A, Adachi H. The impact of preoperative sarcopenia, defined based on psoas muscle area, on long-term outcomes of heart valve surgery. J Thorac Cardiovasc Surg. 2019 Mar;157(3):1071-1079.e3. doi: 10.1016/j.jtcvs.2018.06.098. Epub 2018 Jul 27.
• Paknikar R, Friedman J, Cron D, Deeb GM, Chetcuti S, Grossman PM, Wang S, Englesbe M, Patel HJ. Psoas muscle size as a frailty measure for open and transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. 2016 Mar;151(3):745-751. doi: 10.1016/j.jtcvs.2015.11.022. Epub 2015 Nov 21.
• Rodge GA, Goenka U, Jajodia S, Agarwal R, Afzalpurkar S, Roy A, Goenka MK. Psoas Muscle Index: A Simple and Reliable Method of Sarcopenia Assessment on Computed Tomography Scan in Chronic Liver Disease and its Impact on Mortality. J Clin Exp Hepatol. 2023 Mar-Apr;13(2):196-202. doi: 10.1016/j.jceh.2022.12.002. Epub 2022 Dec 9.
• Walston JD. Sarcopenia in older adults. Curr Opin Rheumatol. 2012 Nov;24(6):623-7. doi: 10.1097/BOR.0b013e328358d59b.
• Xu JY, Li C, Zhang H, Liu Y, Wei JM. Total Psoas Area Index is Valuable to Assess Sarcopenia, Sarcopenic Overweight/Obesity and Predict Outcomes in Patients Undergoing Open Pancreatoduodenectomy. Risk Manag Healthc Policy. 2020 Jul 9;13:761-770. doi: 10.2147/RMHP.S257677. eCollection 2020.
• Wu XL, Shen J, Danzeng CD, Xu XS, Cao ZX, Jiang W. CT psoas calculations on the prognosis prediction of emergency laparotomy: a single-center, retrospective cohort study in eastern Asian population. World J Emerg Surg. 2022 Jun 3;17(1):31. doi: 10.1186/s13017-022-00435-x.
• Yamashita M, Kamiya K, Matsunaga A, Kitamura T, Hamazaki N, Matsuzawa R, Nozaki K, Tanaka S, Nakamura T, Maekawa E, Masuda T, Ako J, Miyaji K. Prognostic Value of Psoas Muscle Area and Density in Patients Who Undergo Cardiovascular Surgery. Can J Cardiol. 2017 Dec;33(12):1652-1659. doi: 10.1016/j.cjca.2017.10.009. Epub 2017 Oct 16.
• Zuckerman J, Ades M, Mullie L, Trnkus A, Morin JF, Langlois Y, Ma F, Levental M, Morais JA, Afilalo J. Psoas Muscle Area and Length of Stay in Older Adults Undergoing Cardiac Operations. Ann Thorac Surg. 2017 May;103(5):1498-1504. doi: 10.1016/j.athoracsur.2016.09.005. Epub 2016 Nov 15.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Minimally invasive cardiac surgery; Psoas Muscle Index
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Heart Valve Diseases
• Other Study ID Numbers: PsoMICS L2097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No