Rate of Left Ventricular Systolic Function's Recuperation After Cardiac Surgery With Extracorporeal Circulation.

Myocardial Stunning Clinical Trial

— Imacor-1  

Official title:

Rate of Left Ventricular Systolic Function's Recuperation After Cardiac Surgery With Extracorporeal Circulation.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02770183
• Other study ID #: CERU-1601
• Status: Withdrawn
• Start date: December 1, 2019
• Est. completion date: December 2020

Study information

• Verified date: May 2022
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The rational of the study is the description of the evolution of systolic cardiac function post-stunning, evaluated by transesophageal minimally invasive echocardiography (hTEE). The uses of these non-invasive methods have proved to be accurate for the qualitative and semi-quantitative determination of the contractile function of the left ventricle and the volume status of the patient. Furthermore the use of this technique has been demonstrated to be a reliable method to analyze the stunning recovery infarction after controlled cardiac arrest during the extra-corporeal circulation.

Description:

Myocardial stunning is a secondary pathophysiologic condition for a sustained reduction in myocardial perfusion, which produces kinetic abnormalities in left ventricular wall that persist for hours or days after the reperfusion phase. The physiological elements of the stunning are: a) reduction in coronary blood flow, b) a partial or complete restoration of coronary artery circulation and c) the dysfunction of persistence for a limited period, but longer compared to recovery coronaire's flow.

Cardiac surgery with cardiopulmonary bypass is a leading cause of bewilderment myocardique. This technique associated with administering a cardioplegic solution used to stop the heart and myocardial protection on ischemia see myocardique consideration. It typically also secondary to secondary inflammatory condition in the extracorporeal circulation and the ischemia-reperfusion phenomenon (formation of free radicals), also with the important activation coagulation. Myocardial stunning occurs in suites aortic unclamping during cardiopulmonary bypass. Cold ischemia performed by a cardioplegic liquid at 4 °C results in reduced energy demands and thus to maintain some balance between metabolism, perfusion and myocardial function during coronary by-pass. When aortic unclamping, there is usually a pure myocardial stunning (without necrosis). After the coronary by-pass, the myocardial thickening fraction is unchanged in the immediate future, but significantly decreased in the hours before a full recovery between the following hours. In the factors associated with changes in systolic function, autonomic nervous system is responsible for the regulation of blood pressure and heart function in response to the stress of the coronary by-pass and the postoperative state. Reduced variability in heart rate (heart rate variability - HRV) heard how sign of autonomic dysfunction is also associated with myocardial stunning with a rate of cardiaque post-surgery complications high.

So far no group has had the opportunity to study "in vivo" the temporal evolution of myocardial stunning after the coronary by-pass as an example of myocardial stunning "controlled" in order to better understand the pathophysiology of 'event. Indeed, the basis of myocardial function recovery time following coronary by-pass is unknown and the impact of intraoperative procedures on this recovery.

Transesophageal echocardiography, that is the gold standard for assessment of systolic function, has gradually gained popularity and is used daily in the ICU to evaluate the patient's hemodynamic status and evaluation of contractile function of the left ventricle to load. One of its advantages is to measure heart activity at the bedside and assist the physician in intensive care in the management of hemodynamic acute changes. It also allows also to analyze the response to treatment defined above. Among the limitations of transesophageal echocardiography are: the need for intensivists to be relevant to this technique, the discontinuous nature of the procedure ( "one shot" monitoring) and finally semi-invasif character that make it difficult 'prolonged and repeated execution of the various measures.

Recent improvement in electronics has enabled the development of miniaturized sensors for hemodynamic transesophageal echocardiography (ImaCor® ClariTEE®), called hTEE (hemodynamic trans-esophageal echocardiography), which are used to perform an extended hemodynamic monitoring ventilated patients; these prototypes are not yet widespread in Intensive Care Unit; their diagnostic capabilities and therapeutic impacts are currently under clinical research. been studies in the past allowed us to validate the clinical image quality and how the clinical information obtained are useful for clinical management of patient. In particular, these studies have demonstrated the ease with which thanks to the small size of the probe, the feedback of the superior vena cava, the patient's volume status, left ventricular systolic function based on the Fractional Area Change, the size of the right ventricle, and a pericardial effusion and cardiac tamponade during the first test of positioning sonde.

The advantages of continuous Htee of this new technique are related to the small size of the probe, ease of positioning the probe in the esophagus, the diagnostic reliability and the ability to stay up to 72 hours because the risk of pressure sores or lesions are comparable to those of a nasogastric feeding tube (which is the same size). Compared to the conventional trans-esophageal echocardiography, hTEE offers the advantage of performing continuous monitoring rather than a case-by case basis. In particular, for the study of post-operative myocardial stunning, this technique allows for a verification of the time course of myocardial stunning, and thus describe the pathophysiology and the kinetics of recovery of left ventricular contractile function. Furthermore this technique provides the means to identify perioperative factors that can change this recovery (induce or shorten).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (over 18 years), waiting for a heart surgery

• Patients of both sexes

• Patients hospitalized in intensive care after the operation

• Informed consent available

Exclusion Criteria:

• Patients with contraindications to the placement of a nasogastric tube for the presence of esophageal varices, esophageal lesions or esophageal-gastric complications known.

• Patients with severe sepsis or septic shock, according to international definitions.

• Patients with severe coagulopathy defined as a lower thrombocytopenia at 20 G / L and / or INR> 2.5 and / or aPTT in the therapeutic range and / or an anti-Xa activity in the ultra-therapeutic range and / or a fibrinogen value less than 1 g / L.

• Patients with poor prognosis.

Related Conditions & MeSH terms

• Circulation, Extracorporeal
• Myocardial Stunning
• Transesophageal Echocardiography

Intervention

Device:
• Imacor
In ICU, the doctors in charge places the probe in the esophagus, executing a series of morphological evaluations and semi-quantitative evaluations. Each image is saved as a video loop or a static image, to have a basic data for each patient and perform an off-line analysis. At the end of the first recording, the esophageal probe is left in the neutral position in the stomach, to eliminate any risk associated with a local increase of pressure. During the stay in the intensive care unit until the end of the study, the esophageal probe will be left in the neutral position, to run every two hours a new echocardiographic assessment on the main window, similar to the first evaluation, always recording loop-video and photographs, to have a time course of recovery of cardiac contractile function. All images will be stored in a digital archive.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

References & Publications (18)

Begot E, Dalmay F, Etchecopar C, Clavel M, Pichon N, Francois B, Lang R, Vignon P. Hemodynamic assessment of ventilated ICU patients with cardiorespiratory failure using a miniaturized multiplane transesophageal echocardiography probe. Intensive Care Med. — View Citation

Bolli R. Myocardial 'stunning' in man. Circulation. 1992 Dec;86(6):1671-91. Review. — View Citation

Braunwald E, Kloner RA. The stunned myocardium: prolonged, postischemic ventricular dysfunction. Circulation. 1982 Dec;66(6):1146-9. Review. — View Citation

Compostella L, Russo N, Compostella C, Setzu T, D'Onofrio A, Isabella G, Tarantini G, Iliceto S, Gerosa G, Bellotto F. Impact of type of intervention for aortic valve replacement on heart rate variability. Int J Cardiol. 2015 Oct 15;197:11-5. doi: 10.1016 — View Citation

Day JR, Taylor KM. The systemic inflammatory response syndrome and cardiopulmonary bypass. Int J Surg. 2005;3(2):129-40. Epub 2005 Aug 1. — View Citation

Dixon B, Santamaria J, Campbell D. Coagulation activation and organ dysfunction following cardiac surgery. Chest. 2005 Jul;128(1):229-36. — View Citation

Esmon CT. The interactions between inflammation and coagulation. Br J Haematol. 2005 Nov;131(4):417-30. Review. — View Citation

Etchecopar-Chevreuil C, François B, Clavel M, Pichon N, Gastinne H, Vignon P. Cardiac morphological and functional changes during early septic shock: a transesophageal echocardiographic study. Intensive Care Med. 2008 Feb;34(2):250-6. Epub 2007 Nov 15. — View Citation

Heyndrickx GR, Millard RW, McRitchie RJ, Maroko PR, Vatner SF. Regional myocardial functional and electrophysiological alterations after brief coronary artery occlusion in conscious dogs. J Clin Invest. 1975 Oct;56(4):978-85. — View Citation

Imren Y, Tasoglu I, Oktar GL, Benson A, Naseem T, Cheema FH, Unal Y. The importance of transesophageal echocardiography in diagnosis of pericardial tamponade after cardiac surgery. J Card Surg. 2008 Sep-Oct;23(5):450-3. doi: 10.1111/j.1540-8191.2008.00581 — View Citation

Marban E. Myocardial stunning and hibernation. The physiology behind the colloquialisms. Circulation. 1991 Feb;83(2):681-8. Review. — View Citation

Slama MA, Novara A, Van de Putte P, Diebold B, Safavian A, Safar M, Ossart M, Fagon JY. Diagnostic and therapeutic implications of transesophageal echocardiography in medical ICU patients with unexplained shock, hypoxemia, or suspected endocarditis. Inten — View Citation

Treskatsch S, Balzer F, Knebel F, Habicher M, Braun JP, Kastrup M, Grubitzsch H, Wernecke KD, Spies C, Sander M. Feasibility and influence of hTEE monitoring on postoperative management in cardiac surgery patients. Int J Cardiovasc Imaging. 2015 Oct;31(7) — View Citation

Vieillard-Baron A, Prin S, Chergui K, Dubourg O, Jardin F. Hemodynamic instability in sepsis: bedside assessment by Doppler echocardiography. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1270-6. Review. — View Citation

Vieillard-Baron A, Slama M, Mayo P, Charron C, Amiel JB, Esterez C, Leleu F, Repesse X, Vignon P. A pilot study on safety and clinical utility of a single-use 72-hour indwelling transesophageal echocardiography probe. Intensive Care Med. 2013 Apr;39(4):62 — View Citation

Vignon P, Mentec H, Terré S, Gastinne H, Guéret P, Lemaire F. Diagnostic accuracy and therapeutic impact of transthoracic and transesophageal echocardiography in mechanically ventilated patients in the ICU. Chest. 1994 Dec;106(6):1829-34. — View Citation

Wan S, LeClerc JL, Vincent JL. Inflammatory response to cardiopulmonary bypass: mechanisms involved and possible therapeutic strategies. Chest. 1997 Sep;112(3):676-92. Review. — View Citation

Warren OJ, Watret AL, de Wit KL, Alexiou C, Vincent C, Darzi AW, Athanasiou T. The inflammatory response to cardiopulmonary bypass: part 2--anti-inflammatory therapeutic strategies. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):384-93. doi: 10.1053/j.jvca.20 — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional Area Change analysis	Primary outcome is the evolution of Fractional Area Change for the duration of the study. The assessment of cardiac contractile function, which method is better described below, will be based mainly on a serial analysis of the Fractional Area Change and semi-quantitative assessment of ejection fraction in projection 4 cavities.	72 hours
Secondary	Stratify patients	Identify the presence of specific subgroups of patients, that will correlate the recovery rate of the systolic function with all other clinical, demographic and operational variables, as biologic parameters (age, sex), clinical parameters (like preoperative disease, use of B-blockers, preoperative left-ventricular-ejection-fraction, any dysfunction of sinoatrial node or the recovery of heart rate variability) and peri-operative parameters (like duration of extra-corporeal circulation, type of cardioplegia, duration of surgery, use of amine, hemoglobin values after surgery, etc...)	72 hours