Clinical trial NCT06539000: Preoperative Risk Score for Postoperative Right Ventricular Dysfunction in Adult Cardiac Surgery
Official title: The "RIGHT-SCORE" Study: a Preoperative Risk Score for Postoperative Right Ventricular Dysfunction in Adult Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Right Ventricular Dysfunction
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who underwent cardiac surgery between January 2016 and December 2023 at the Policlinico Fondazione Campus BioMedico.

Brief summary: 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.

Detailed description: 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 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.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* elective or urgent cardiac surgery at Campus BioMedico between January 2016 to December 2023
* postoperative echocardiogram execution
* ASA class I-IV

Exclusion Criteria:

* age \< 18 years
* inotropic therapy at the time of surgery

Primary outcomes:
measure: Creation of a preoperative risk score for predicting the development of right ventricular dysfunction after adult cardiac surgery.
timeFrame: September 2024 - April 2025
Secondary outcomes:
measure: 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.
timeFrame: September 2024 - April 2025
measure: Correlation between postoperative RVD and postoperative outcomes.
timeFrame: September 2024 - April 2025
measure: Sub-analysis of the risk score.
timeFrame: September 2024 - April 2025
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
state: Lazio
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. doi: 10.1016/s0967-2109(99)00089-7.
citation: 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.