Early Postoperative Blood Glucose Variability and Outcome After TAVI (GLYTAVI)

Early Postoperative Blood Glucose Variability and Outcome After TAVI : a Retrospective Single-centre Study

Stress hyperglycaemia is a well-known risk factor of postoperative morbidity and mortality in cardiac surgery. Recently, several authors have reported that increased blood glucose (BG) variability could worsen the prognosis in this population.The transcatheter aortic valve implantation (TAVI) is a low invasive procedure proposed as an alternative technique to aortic valve replacement surgery in high-risk patients.

The aim of this study is to describe the incidence of stress hyperglycaemia and assess whether BG variability could impact the outcome of patients undergoing TAVI.

Study Overview

• Status: Completed
• Conditions: Stress Hyperglycemia

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25000
    • CHRU Jean Minjoz Besancon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Planned transcatheter aortic valve implantation

Description

Inclusion Criteria:

• age>18 years old
• severe degenerative symptomatic aortic stenosis
• logistic Euroscore ≥ 20% or/and Society of Thoracic Surgeons score (STS) ≥ 10%
• recused for a conventional valve replacement by multidisciplinary team (surgeon, cardiologist) because of surgical contraindication or comorbidities related to the patient.
• written consent before the procedure concerning anonymous data processing.

Exclusion Criteria:

• death per procedure
• postoperative admission in a critical care unit

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
group M; patients who died or suffered from stroke, acute coronary syndrome, heart failure, complete atrioventricular block or life-threatening ventricular arrhythmias within 30 days after the procedure
group T; other patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of stress hyperglycemia	Stress hyperglycemia is defined as a blood glucose value above 7.7 mmol/l requiring insulin infusion within the 48 first hours following the TAVI.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean blood glucose value	Mean blood glucose value is the mean of all the blood glucose values measured during the 48 first hours following the TAVI.	48 hours
Standard deviation of blood glucose value	Standard deviation of glucose value is the standard deviation of all the blood glucose values measured during the 48 first hours following the TAVI.	48 hours
Incidence of moderate hypoglycemia	Moderate hypoglycemia is defined as a blood glucose value under 3.3 mmol/l.	48 hours
Incidence of severe hypoglycemia	Severe hypoglycemia is defined as a blood glucose value under 2.2 mmol/l.	48 hours
Incidence of severe hyperglycemia	Severe hyperglycemia is defined as a blood glucose value above 11.0 mmol/l.	48 hours
Coefficient of variability of blood glucose	The coefficient of variability is the ratio of the standard deviation on the mean blood glucose value, expressed as a percentage.	48 hours
Mean daily variation of blood glucose	The mean daily variation of blood glucose is defined as the mean of the daily differences between the maximal and the minimal glucose value.	48 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Study Chair: Sophie DEPIERRE, Centre Hospitalier Régional Universitaire de Besançon

Publications and helpful links

General Publications

• Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.
• Goldberg PA, Sakharova OV, Barrett PW, Falko LN, Roussel MG, Bak L, Blake-Holmes D, Marieb NJ, Inzucchi SE. Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings. J Cardiothorac Vasc Anesth. 2004 Dec;18(6):690-7. doi: 10.1053/j.jvca.2004.08.003.
• Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux JL, Pavie A, Gueret P; FRANCE Registry Investigators. Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J. 2011 Jan;32(2):191-7. doi: 10.1093/eurheartj/ehq261. Epub 2010 Sep 15.
• Meyfroidt G, Keenan DM, Wang X, Wouters PJ, Veldhuis JD, Van den Berghe G. Dynamic characteristics of blood glucose time series during the course of critical illness: effects of intensive insulin therapy and relative association with mortality. Crit Care Med. 2010 Apr;38(4):1021-9. doi: 10.1097/CCM.0b013e3181cf710e.
• Dossett LA, Cao H, Mowery NT, Dortch MJ, Morris JM Jr, May AK. Blood glucose variability is associated with mortality in the surgical intensive care unit. Am Surg. 2008 Aug;74(8):679-85; discussion 685. doi: 10.1177/000313480807400802.
• Bagshaw SM, Bellomo R, Jacka MJ, Egi M, Hart GK, George C; ANZICS CORE Management Committee. The impact of early hypoglycemia and blood glucose variability on outcome in critical illness. Crit Care. 2009;13(3):R91. doi: 10.1186/cc7921. Epub 2009 Jun 17.
• Egi M, Bellomo R, Reade MC. Is reducing variability of blood glucose the real but hidden target of intensive insulin therapy? Crit Care. 2009;13(2):302. doi: 10.1186/cc7755. Epub 2009 Apr 6.
• Besch G, Pili-Floury S, Morel C, Gilard M, Flicoteaux G, Salomon du Mont L, Perrotti A, Meneveau N, Chocron S, Schiele F, Le Breton H, Samain E, Chopard R. Impact of post-procedural glycemic variability on cardiovascular morbidity and mortality after transcatheter aortic valve implantation: a post hoc cohort analysis. Cardiovasc Diabetol. 2019 Mar 11;18(1):27. doi: 10.1186/s12933-019-0831-3.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: aortic valve replacement; TAVI; percutaneous valve; blood glucose variability
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: EI/2014/141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO