Congestive Heart Failure, Right Heart Failure, Right Ventricular Dysfunction
Conditions
Keywords
Right Ventricular Pressure Waveform
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. The investigator's 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
Right ventricular (RV) dysfunction is mostly associated to a decrease in contractility, right ventricular pressure overload or right ventricular volume overload. RV dysfunction can occur in a number of 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. 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: 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. However, echocardiographic indices alone are insufficient in describing RV function. The diagnosis of fulminant RV failure is more easily recognised as a combination of echocardiographic measures, compromised hemodynamic measures and clinical presentation. 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. The gold standard for measuring pulmonary pressure is still the pulmonary artery catheter. However, RV output can initially be preserved despite of pulmonary hypertension. 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.
Interventions
None listed
Sponsors
Edwards Lifesciences
Montreal Heart Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Male or female patients, age 18 and older, undergoing cardiac surgery and receiving standard of care monitoring utilizing a pulmonary artery catheter.
Exclusion criteria
* Emergency surgery or inability to obtain consent * Concomitant diseases such as pericardial constriction, congenital heart disease, severe valvular regurgitation, right ventricular systolic dysfunction, or right ventricular infarction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 30 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 discharge | 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. |
| Duration of hospital stay (in days) | 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 | Defined as the difference between the maximal and the minimal velocity during the cardiac cycle divided by the maximal velocity |
| 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 |
Countries
Canada
Contacts
Primary ContactSophie Robichaud, RRT
Backup ContactSamuel Côté, RRT
Outcome results
None listed