Clinical trial NCT04782154: Paceport Swan-Ganz Data Collection Study
Official title: Paceport Swan-Ganz Data Collection Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Right Ventricular Dysfunction
Right Heart Failure
Congestive Heart Failure
Keywords: Right Ventricular Pressure Waveform
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2021-03-04
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ≥ 18 years of age, with planned surgery or liver transplantation, projected to receive Swan-Ganz as part of the procedure/standard of care with intermittent cardiac output measures will be screened for inclusion into the Study. Only subjects meeting all inclusion criteria will be enrolled.

Brief summary: RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes. However, so far, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU. Our primary hypothesis is that the prevalence of abnormal RV pressure waveform occurs in more than 50% of cardiac surgical patients throughout their hospitalization. Those patients with abnormal RV pressure waveform will be more prone to post-operative complications related to RV dysfunction and failure in the OR and ICU.

Detailed description: The pulmonary artery catheter (PAC) consists of an intravenous device placed in the pulmonary artery to measure cardiac output, pulmonary artery pressures (Richard C, 2011) as well as cardiac filling pressures. Since its initial presentation by Swan in 1970 (H J Swan, 1970), several modifications were made on the initial catheter now allowing continuous assessment of cardiac output, continuous monitoring of stroke volume (SV), systemic vascular resistance (SVR) and mixed venous saturation (SvO2) (Arora, 2014) (H J Swan, 1970) (Richard C, 2011). We intend to enhance current Swan-Ganz catheters with clinical decision support tools to early identify hemodynamically unstable states that can lead to further deterioration of the patient's health state.

Right ventricular (RV) dysfunction is mostly associated to a decrease in contractility, right ventricular pressure overload or right ventricular volume overload (François Haddad, 2008). RV dysfunction can occur in several clinical scenarios in the intensive care unit (ICU) and operating room (OR): pulmonary embolism, acute respiratory distress syndrome (ARDS), septic shock, RV infarction, and in pulmonary hypertensive patients undergoing cardiac surgery (François Haddad, 2008). RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients (André Y. Denault, 2006) (Denault AY B. J.-S., 2016). Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes. Unfortunately, identifying which patients will develop RV dysfunction and then progress towards RV failure have proven difficult. One of the reasons for delaying the diagnosis of RV dysfunction could be the lack of uniform definition, especially in the perioperative period. Echocardiographic definitions of RV dysfunction have been described in previous studies: RV fractional area change (RVFAC) \< 35 %, tricuspid annular plane systolic excursion (TAPSE) \< 16 mm, tissue Doppler S wave velocity \<10 cm/s, RV ejection fraction (RVEF) \<45% and RV dilation have been related to RV dysfunction (Rudski LG, 2010). However, these echocardiographic indices cannot be continuously monitored and are insufficient in describing RV function. The diagnosis of fulminant RV failure is more easily recognized as a combination of echocardiographic measures, compromised hemodynamic measures and clinical presentation (Raymond M, 2019) (François Haddad, 2008) (Haddad F, 2009). RV dysfunction is inevitably associated with absolute or relative pulmonary hypertension because of the anatomic and physiological connection between the RV and pulmonary vascular system (Naeije R, 2014) (François Haddad, 2008). The gold standard for measuring pulmonary pressure is still the pulmonary artery catheter. However, RV output can initially be preserved despite of pulmonary hypertension (Denault AY C. M., 2006). It is therefore mandatory that early, objective, continuous, easily obtainable and subclinical indices of RV dysfunction are found and validated to initiate early treatment of this disease.

Since 2002, Dr Denault's group at Montreal Heart Institute has been using continuous RV pressure waveform monitoring initially for the diagnosis of RV outflow tract obstruction (Denault A, 2014) and then for RV diastolic dysfunction evaluation (St-Pierre P, 2014) (Myriam Amsallem, 2016). Preliminary data based on a retrospective study on 259 patients found that 110 (42.5%) patients had abnormal RV gradients before cardiopulmonary bypass (CPB).Abnormal RV diastolic pressure gradient was associated with higher EuroSCORE II (2.29 \[1.10-4.78\] vs. 1.62 \[1.10-3.04\], p=0.041), higher incidence of RV diastolic dysfunction using echocardiography (45 % vs. 29 %, p=0.038), higher body mass index (BMI) (27.0 \[24.9-30.5\] vs. 28.9 \[25.5-32.5\], p=0.022), pulmonary hypertension (mean pulmonary artery pressure (MPAP) \> 25 mmHg) (37 % vs. 48 %, p=0.005) and lower pulmonary artery pulsatility index (PAPi) (1.59 \[1.19-2.09\] vs. 1.18 \[0.92-1.54\], p\<0.0001). Patients with abnormal RV gradient had more frequent difficult separation from CPB (32 % vs. 19 %, p=0.033) and more often received inhaled pulmonary vasodilator treatment before CPB (50 % vs. 74 %, p\<0.001). However, this was retrospective and limited to the pre-CPB period.

In 2017, in a review article on RV failure in the ICU (Hrymak C, 2017), RV pressure waveform monitoring using the paceport of the pulmonary artery catheter was recommended as a simple method of monitoring RV function (Rubenfeld GD, 1999). However, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU.

Eligibility criteria: Inclusion Criteria:

* Be ≥ 18 years of age
* Participate in the Informed Consent process and sign/date the approved informed consent forms
* Projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (SvO2) measures

Exclusion Criteria:

* Refuse to sign consent
* Have left bundle branch block
* Have recurrent sepsis
* Have hypercoagulopathy
* Allergic to FORE-SIGHT Elite sensor adhesive
* Latex allergy due to presence of latex in the Swan-Ganz catheter balloon.

Primary outcomes:
measure: Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU
timeFrame: From thermodilution catheter insertion until 2 hours after ICU arrival
Secondary outcomes:
measure: Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery
timeFrame: From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours
measure: Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of deaths during hospitalisation
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of acute kidney injury (AKI)
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of major bleeding
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of surgical reintervention for any reasons
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of deep sternal wound infection or mediastinitis
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of delirium
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of stroke
timeFrame: Up to 28 days or until hospital discharge
measure: Total duration of ICU stay in hours
timeFrame: Up to 28 days or until hospital discharg
measure: Duration of vasopressor requirements (in hours)
timeFrame: Up to 28 days or until hospital discharge
measure: Up to 28 days or until hospital discharge
timeFrame: Up to 28 days or until hospital discharge
measure: Duration of mechanical ventilation (in hours)
timeFrame: Up to 28 days or until hospital discharge
measure: Incidence of major morbidity or mortality
timeFrame: Up to 28 days or until hospital discharge
measure: Right ventricular ejection fraction
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular fractional area change
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular strain
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Tricuspid annular plane systolic excursion
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular performance index
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Portal flow pulsatility fraction
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular stroke work index
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Relative pulmonary pressure
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular function index
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Pulmonary artery pulsatility index (PAPi)
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Compliance of the pulmonary artery (CPA)
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Pulsatility of femoral venous flow
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
measure: Right ventricular outflow tract obstruction
timeFrame: From arrival to the operating room until 2 hours after ICU arrival
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Andre Y Denault, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Denault AY, Couture P, Buithieu J, Haddad F, Carrier M, Babin D, Levesque S, Tardif JC. Left and right ventricular diastolic dysfunction as predictors of difficult separation from cardiopulmonary bypass. Can J Anaesth. 2006 Oct;53(10):1020-9. doi: 10.1007/BF03022532.
citation: Mehta Y, Arora D. Newer methods of cardiac output monitoring. World J Cardiol. 2014 Sep 26;6(9):1022-9. doi: 10.4330/wjc.v6.i9.1022.
citation: Denault A, Lamarche Y, Rochon A, Cogan J, Liszkowski M, Lebon JS, Ayoub C, Taillefer J, Blain R, Viens C, Couture P, Deschamps A. Innovative approaches in the perioperative care of the cardiac surgical patient in the operating room and intensive care unit. Can J Cardiol. 2014 Dec;30(12 Suppl):S459-77. doi: 10.1016/j.cjca.2014.09.029. Epub 2014 Oct 5.
citation: Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.
citation: Denault AY, Chaput M, Couture P, Hebert Y, Haddad F, Tardif JC. Dynamic right ventricular outflow tract obstruction in cardiac surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):43-9. doi: 10.1016/j.jtcvs.2006.03.014.
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citation: Hrymak C, Strumpher J, Jacobsohn E. Acute Right Ventricle Failure in the Intensive Care Unit: Assessment and Management. Can J Cardiol. 2017 Jan;33(1):61-71. doi: 10.1016/j.cjca.2016.10.030. Epub 2016 Nov 11.
citation: Amsallem M, Kuznetsova T, Hanneman K, Denault A, Haddad F. Right heart imaging in patients with heart failure: a tale of two ventricles. Curr Opin Cardiol. 2016 Sep;31(5):469-82. doi: 10.1097/HCO.0000000000000315.
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citation: St-Pierre P, Deschamps A, Cartier R, Basmadjian AJ, Denault AY. Inhaled milrinone and epoprostenol in a patient with severe pulmonary hypertension, right ventricular failure, and reduced baseline brain saturation value from a left atrial myxoma. J Cardiothorac Vasc Anesth. 2014 Jun;28(3):723-9. doi: 10.1053/j.jvca.2012.10.017. Epub 2013 Apr 26. No abstract available.