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Right ventricular dysfunction (RVD) is common following cardiac surgery, and it is characterised by impaired right ventricular function that can lead to decreased cardiac output and hemodynamic instability. RVD is consistently associated with poor outcomes.
The mechanisms behind RVD post-surgery involve changes in preload, after load, and RV contraction. Factors linked to higher incidence of postoperative RVD include decreased tricuspid annular plane excursion (TAPSE), elevated preoperative pulmonary artery pressure, lung diseases, duration of extracorporeal circulation, and left valve surgery.
While predictive scores for RVD exist for left ventricular assist device (LVAD) patients, no such models are available for other cardiac surgeries. Identifying specific predictors could lead to models that identify high-risk patients, allowing for tailored monitoring and treatment strategies.
The primary aim of this study is to create a preoperative risk score for predicting the development of right ventricular dysfunction following adult cardiac surgery through a retrospective analysis on patients who underwent heart surgery.
Postoperative RVD will be defined as:
- Echocardiographic parameters suggestive of RVD (at least 2 out of 3): TAPSE < 16 mmHg; right ventricular fractional area change (RVFAC) < 35%; right ventricular end systolic dilation > 3,5 cm (measured from the septum to the free wall).
AND
- Need for inotropic and/or pulmonary vasodilator drug support and/or mechanical support.
Data will be collected retrospectively on: demographic characteristics; basic patient characteristics (weight, height, Body Mass Index -BMI, etc.); preoperative pharmacological therapy; preoperative comorbidities; abnormalities in blood tests; chest X-rays and ECGs; abnormalities in coronary angiography and carotid ultrasound; preoperative echocardiographic examination: TAPSE, Left Ventricular Ejection Fraction- LVEF, valvular pathologies, Pulmonary Artery Systolic Pressure- PAPs, pericardial effusion; type of surgical intervention; occlusion of the posterior interventricular coronary artery (acute or chronic); duration of the surgical procedure; duration of extracorporeal circulation; non-revascularized right coronary artery disease; blood product transfusions; postoperative pharmacological therapy (with particular regard to the use of inotropes/pulmonary vasodilators/vasopressors); postoperative echocardiographic examination: TAPSE; RVFAC; right ventricular dilation at end-systole; postoperative complications; Intensive Care Unit (ICU) length of stay and hospital length of stay.
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| Measure | Description | Time Frame |
|---|---|---|
| Creation of a preoperative risk score for predicting the development of right ventricular dysfunction after adult cardiac surgery. | Preoperative patient characteristics (demographic features, BMI, preoperative conditions, etc.) and surgical factors (type of procedure, duration of cardiopulmonary bypass, duration of surgery, etc.) will be correlated with the development of RVD in the early postoperative period. Scores will be assigned to factors showing significant correlation. The sum of these scores will yield the total score and thus the risk level. Unabbreviated score title: The RightScore Minimum/maximum values: Depending on the number of risk factors associated with right ventricular dysfunction. Higher scores indicate worse outcomes. | September 2024 - December 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective validation of the created score (The RightScore) on adult cardiac surgery patients operated at Policlinico Fondazione Campus Bio-Medico between January 2016 and December 2023. | The RightScore will be calculated using retrospectively analyzed data for every adult patient operated on at Policlinico Fondazione Campus Bio-Medico between January 2016 and December 2023. Preoperative and intraoperative data will be used to predict postoperative right ventricular dysfunction. This prediction will be correlated with the actual development of postoperative right ventricular dysfunction to retrospectively validate the score created. Unabbreviated score title: The RightScore Minimum/maximum values: Depending on the number of risk factors associated with right ventricular dysfunction. Higher scores indicate worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who underwent cardiac surgery between January 2016 and December 2023 at the Policlinico Fondazione Campus BioMedico.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Campus Bio-Medico | Rome | Lazio | 00128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38002763 | Background | Mattei A, Strumia A, Benedetto M, Nenna A, Schiavoni L, Barbato R, Mastroianni C, Giacinto O, Lusini M, Chello M, Carassiti M. Perioperative Right Ventricular Dysfunction and Abnormalities of the Tricuspid Valve Apparatus in Patients Undergoing Cardiac Surgery. J Clin Med. 2023 Nov 17;12(22):7152. doi: 10.3390/jcm12227152. | |
| 34898875 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2024 | Aug 2, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D018497 | Ventricular Dysfunction, Right |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| September 2024 - December 2025 |
| Correlation between postoperative RVD and postoperative outcomes. | Correlation with mortality, stroke, multi-organ dysfunction, re-intubation, cardiac arrest, increased length of stay in the ICU, increased hospital stay. | September 2024 - December 2025 |
| Sub-analysis of the risk score. | Sub-analysis of the risk score for the subtype of surgery performed by the patient. Unabbreviated score title: The RightScore Minimum/maximum values: Depending on the number of risk factors associated with right ventricular dysfunction. Higher scores indicate worse outcomes. | September 2024 - December 2025 |
| Varma PK, Jose RL, Krishna N, Srimurugan B, Valooran GJ, Jayant A. Perioperative right ventricular function and dysfunction in adult cardiac surgery-focused review (part 1-anatomy, pathophysiology, and diagnosis). Indian J Thorac Cardiovasc Surg. 2022 Jan;38(1):45-57. doi: 10.1007/s12055-021-01240-y. Epub 2021 Oct 27. |
| 28197291 | Background | Estrada VH, Franco DL, Moreno AA, Gambasica JA, Nunez CC. Postoperative Right Ventricular Failure in Cardiac Surgery. Cardiol Res. 2016 Dec;7(6):185-195. doi: 10.14740/cr500e. Epub 2016 Dec 31. |
| 10661697 | Background | Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. doi: 10.1177/096721090000800101. |
| 18510965 | Background | Matthews JC, Koelling TM, Pagani FD, Aaronson KD. The right ventricular failure risk score a pre-operative tool for assessing the risk of right ventricular failure in left ventricular assist device candidates. J Am Coll Cardiol. 2008 Jun 3;51(22):2163-72. doi: 10.1016/j.jacc.2008.03.009. |