Paceport Swan-Ganz Data Collection Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU [From thermodilution catheter insertion until 2 hours after ICU arrival]
Abnormal RV pressure waveform will be defined as a difference between the RV end-diastolic minus the early-diastolic pressure > 4 mmHg and a RVdP/dt < 400 mmHg.
Secondary Outcome Measures
- Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery [From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours]
Difficult separation from cardiopulmonary bypass: instability requiring at least two different types of pharmacological agents (i.e., inotropes ± vasopressors ± inhaled agents) Complex separation from cardiopulmonary bypass: Hemodynamic instability requiring return on cardiopulmonary bypass or addition of mechanical support (intra-aortic balloon pump or extra-corporeal membrane oxygenator)
- Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery [Up to 28 days or until hospital discharge]
TPOD is a continuous variable representative of the burden of care and morbidity during the first 28 days following cardiac surgery and was chosen to circumvent issues arising for using other clinical endpoint such as ICU length of stay
- Incidence of deaths during hospitalisation [Up to 28 days or until hospital discharge]
Death from any cause
- Incidence of acute kidney injury (AKI) [Up to 28 days or until hospital discharge]
Acute kidney injury (AKI) according to KDIGO serum creatinine criteria: Stage 1: ≥50% or 27 umol/L increases in serum creatinine, Stage 2: ≥100% increase in serum creatinine, Stage 3 ≥200% increase in serum creatinine or an increase to a level of ≥254 umol/L or dialysis initiation.
- Incidence of major bleeding [Up to 28 days or until hospital discharge]
Major bleeding is defined by the Bleeding Academic Research Consortium (BARC) as one of the following: • Perioperative intracranial bleeding within 48h • Reoperation after closure of sternotomy for the purpose of controlling bleeding • Transfusion of ≥5 units of whole blood of packed red blood cells within a 48 hours period • Chest tube output ≥2L within a 24 hours period
- Incidence of surgical reintervention for any reasons [Up to 28 days or until hospital discharge]
Re-operation after the initial surgery for any cause
- Incidence of deep sternal wound infection or mediastinitis [Up to 28 days or until hospital discharge]
Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician
- Incidence of delirium [Up to 28 days or until hospital discharge]
Delirium is defined as an intensive care delirium screening checklist (ICDSC) score(18) of ≥4 in the week following surgery or positive result for the Confusion Assessment Method for the ICU (CAM-ICU).
- Incidence of stroke [Up to 28 days or until hospital discharge]
Central neurologic deficit persisting longer than 72 hours
- Total duration of ICU stay in hours [Up to 28 days or until hospital discharg]
Number of hours passed in the ICU
- Duration of vasopressor requirements (in hours) [Up to 28 days or until hospital discharge]
Vasopressors include norepinephrine, epinephrine, dobutamine, vasopressin, phenylephrine, milrinone, isoproterenol and dopamine
- Up to 28 days or until hospital discharge [Up to 28 days or until hospital discharge]
Number of days hospitalized from the day of surgery to discharge
- Duration of mechanical ventilation (in hours) [Up to 28 days or until hospital discharge]
A duration of >24 hours will be considered prolonged ventilation requirements.
- Incidence of major morbidity or mortality [Up to 28 days or until hospital discharge]
Including death, prolonged ventilation, stroke, renal failure (Stage ≥2), deep sternal wound infection and reoperation for any reason.
- Right ventricular ejection fraction [From arrival to the operating room until 2 hours after ICU arrival]
Assessed by the American Society of Echocardiography guidelines
- Right ventricular fractional area change [From arrival to the operating room until 2 hours after ICU arrival]
Assessed by the American Society of Echocardiography guidelines
- Right ventricular strain [From arrival to the operating room until 2 hours after ICU arrival]
Assessed by the American Society of Echocardiography guidelines
- Tricuspid annular plane systolic excursion [From arrival to the operating room until 2 hours after ICU arrival]
Assessed by the American Society of Echocardiography guidelines
- Right ventricular performance index [From arrival to the operating room until 2 hours after ICU arrival]
Assessed by the American Society of Echocardiography guidelines
- Portal flow pulsatility fraction [From arrival to the operating room until 2 hours after ICU arrival]
Portal flow pulsatility fraction
- Right ventricular stroke work index [From arrival to the operating room until 2 hours after ICU arrival]
0.0136x Stroke volume index x (Mean pulmonary artery pressure-mean right atrial pressure)
- Relative pulmonary pressure [From arrival to the operating room until 2 hours after ICU arrival]
The ratio of the mean systemic arterial pressure divided by the mean pulmonary artery pressure
- Right ventricular function index [From arrival to the operating room until 2 hours after ICU arrival]
Defined as (isovolumic contraction time + isovolumic relaxation time)/RV ejection time
- Pulmonary artery pulsatility index (PAPi) [From arrival to the operating room until 2 hours after ICU arrival]
Defined as (systolic pulmonary artery pressure - diastolic pulmonary artery pressure)/central venous pressure
- Compliance of the pulmonary artery (CPA) [From arrival to the operating room until 2 hours after ICU arrival]
Stroke volume divided by the pulmonary artery pulse pressure (systolic minus the diastolic pulmonary artery pressure)
- Pulsatility of femoral venous flow [From arrival to the operating room until 2 hours after ICU arrival]
Velocity variations of blood flow in the femoral vein during the cardiac cycle
- Right ventricular outflow tract obstruction [From arrival to the operating room until 2 hours after ICU arrival]
Right Ventricular Systolic pressure minus Pulmonary Artery Systolic pressure ≤ 6 mmHg.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montreal Heart Institute | Montreal | Quebec | Canada | H1T 1C8 |
Sponsors and Collaborators
- Montreal Heart Institute
- Edwards Lifesciences
Investigators
- Principal Investigator: Andre Y Denault, MD,PhD, Montreal Heart Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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. Review.
- Denault AY, Bussières JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQ, 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):1140-53. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28.
- Denault AY, Chaput M, Couture P, Hébert Y, Haddad F, Tardif JC. Dynamic right ventricular outflow tract obstruction in cardiac surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):43-9.
- 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.
- Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92. Review.
- Haddad F, Hunt SA, Rosenthal DN, Murphy DJ. Right ventricular function in cardiovascular disease, part I: Anatomy, physiology, aging, and functional assessment of the right ventricle. Circulation. 2008 Mar 18;117(11):1436-48. doi: 10.1161/CIRCULATIONAHA.107.653576. Review.
- 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. Review.
- 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. Review.
- Naeije R, Manes A. The right ventricle in pulmonary arterial hypertension. Eur Respir Rev. 2014 Dec;23(134):476-87. doi: 10.1183/09059180.00007414. Review.
- Raymond M, Grønlykke L, Couture EJ, Desjardins G, Cogan J, Cloutier J, Lamarche Y, L'Allier PL, Ravn HB, Couture P, Deschamps A, Chamberland ME, Ayoub C, Lebon JS, Julien M, Taillefer J, Rochon A, Denault AY. Perioperative Right Ventricular Pressure Monitoring in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1090-1104. doi: 10.1053/j.jvca.2018.08.198. Epub 2018 Aug 25. Review.
- Richard C, Monnet X, Teboul JL. Pulmonary artery catheter monitoring in 2011. Curr Opin Crit Care. 2011 Jun;17(3):296-302. doi: 10.1097/MCC.0b013e3283466b85. Review.
- Rubenfeld GD, Angus DC, Pinsky MR, Curtis JR, Connors AF Jr, Bernard GR. Outcomes research in critical care: results of the American Thoracic Society Critical Care Assembly Workshop on Outcomes Research. The Members of the Outcomes Research Workshop. Am J Respir Crit Care Med. 1999 Jul;160(1):358-67.
- Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010.
- 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.
- Swan HJ, Ganz W, Forrester J, Marcus H, Diamond G, Chonette D. Catheterization of the heart in man with use of a flow-directed balloon-tipped catheter. N Engl J Med. 1970 Aug 27;283(9):447-51.
- 2018-20