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Prospective validation of the ultrasound-assessed internal jugular vein distensibility (JVD) ratio to identify patients with systolic chronic heart failure and right atrial pressure (RAP) of 7 or less mmHg measured by the right heart catheterization. In a calibration cohort, a threshold ratio will be identified, above which the RAP is normal with the highest accuracy. This diagnostic tool with a defined threshold of the JVD ratio will be assessed in a second prospective validation cohort.
Peripheral congestion is caused by an excess of fluid in tissues and vessels. Fluid overload is associated with poor outcome in heart failure (HF)(1). Several clinical signs can suggest peripheral congestion, such as peripheral edema or neck vein distention. In particular, the clinical sign of the neck jugular vein distention is used to estimate right atrial pressure (RHC) and is associated with fluid overload and congestion. Nevertheless, clinical assessment is somewhat subjective depending on the anatomy of the patient's neck and on the expertise of the physician (2). It has been reported that the detection of elevated RAP can be measured using a bedside ultrasound (US)(3). In this study, the Authors compared the jugular vein distensibility (IVD) ratio assessed with US with the invasive measure of the RAP reporting a good accuracy in detecting normal RAP. They showed a good performance of this diagnostic test, nevertheless, they evaluated this diagnostic test in a mix population including only 27 patients with congestive HF. More recent studies showed the prognostic value of the IVD ratio in patients with HF (4). Nevertheless, a specific threshold of the internal JVD ratio to identify patients with normal RAP in the setting of patients with systolic chronic HF (CHF) has never been described. Furthermore, in patients with CHF clinical signs of congestion cannot always be evident at clinical examination, making the decision to modify diuretic dosage or to introduce vasodilator drugs uneasy. Thus, a convenient, accurate, and reproducible non-invasive tool to identify patients with normal RAP (normal mean RAP is 7 or less mmHg) patients with systolic CHF would be desirable to tailor therapy, in particular in outpatient clinics.
The main hypothesis of this study is that US-assessment of the internal JVD could be an accurate diagnostic tool to identify patients with normal RAP in this challenging set of patients.
The primary aim of the study prospectively validates an US-assessed internal JVD ratio to identify patients with systolic CHF and RAP of 7 or less mmHg measured by RHC. In a calibration cohort, a threshold of the JVD ratio above which the RAP is normal with the highest accuracy will be identified and then this diagnostic tool with a defined JVD ratio will be validated in a second prospective validation cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calibration group | Patients with systolic chronic heart failure who undergo right heart catheterization (RHC) for heart transplant/left ventricular assist device workup. |
| |
| Validation group | Patients with systolic chronic heart failure who undergo RHC for heart transplant/left ventricular assist device workup. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linear ultrasound (US) assessment of the internal jugular vein | Diagnostic Test | Evaluation of jugular vein distensibility at rest and after Valsalva maneuver by US at the time of the RHC. US-guided IJV is routinely performed at the time of vein cannulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of patients with normal RAP (=<7 mmHg) with US-IJVD based on the JVD ratio obtained from the calibration cohort. | Positive predictive value (PPV) of the JVD ratio to identify patients with normal (RAP=<7 mmHg) measured by RHC in the validation group. In particular a higher JVD ratio indicated lower RAP. | From July 2017 to June 2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical major cardiac events among patients included in the calibration group divided on the basis of the JVD ratio | Clinical events include cardiac death, unknown death, cardiac hospitalization, urgent heart transplant, left ventricular assist device implantation. In particular it is expected that patients with JVD ratio above the identified threshold in the calibration group have a better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between JVD ratio and other hemodynamic parameters obtained by RHC | The hemodynamic parameters will include pulmonary artery pressures and pulmonary capillary wedge pressure | From July 2017 to June 2019 |
Inclusion Criteria:
Exclusion Criteria:
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Patients with systolic chronic heart failure defined by a left ventricular ejection fraction (LVEF) <50% on echocardiogram that, undergo elective RHC in the heart transplant/left ventricular assist device work-up.
All procedure, RHC, ultrasound assessment of the IJV, echocardiogram, laboratory test exams are routine exams in the heart transplant/left ventricular assist device work-up or in the staging of patients with advanced HF. No adjunctive procedures have been performed for this specific study.
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| Name | Affiliation | Role |
|---|---|---|
| Enrico Ammirati, MD, PhD | Niguarda Hospital, Milano, Italy | Principal Investigator |
| Fabrizio Oliva, MD | Niguarda Hospital, Milano, Italy | Study Director |
| Davide Marchetti, MD | Università Statale di Milano, Italy | Study Chair |
| Andrea Garascia, MD | Niguarda Hospital, Milano, italy | Study Chair |
| Giada Colombo | Università Statale di Milano, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| De Gasperis Cardio Center, Niguarda Hospital | Milan | Lombardy | 20162 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24622114 | Background | Caldentey G, Khairy P, Roy D, Leduc H, Talajic M, Racine N, White M, O'Meara E, Guertin MC, Rouleau JL, Ducharme A. Prognostic value of the physical examination in patients with heart failure and atrial fibrillation: insights from the AF-CHF trial (atrial fibrillation and chronic heart failure). JACC Heart Fail. 2014 Feb;2(1):15-23. doi: 10.1016/j.jchf.2013.10.004. Epub 2014 Jan 8. | |
| 9665212 |
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The informed consent does not include to make public the individual participant data
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| From July 2017 to June 2019 |
| Background |
| McGee SR. Physical examination of venous pressure: a critical review. Am Heart J. 1998 Jul;136(1):10-8. doi: 10.1016/s0002-8703(98)70175-9. |
| 20211304 | Background | Simon MA, Kliner DE, Girod JP, Moguillansky D, Villanueva FS, Pacella JJ. Detection of elevated right atrial pressure using a simple bedside ultrasound measure. Am Heart J. 2010 Mar;159(3):421-7. doi: 10.1016/j.ahj.2010.01.004. |
| 26006717 | Background | Pellicori P, Kallvikbacka-Bennett A, Dierckx R, Zhang J, Putzu P, Cuthbert J, Boyalla V, Shoaib A, Clark AL, Cleland JG. Prognostic significance of ultrasound-assessed jugular vein distensibility in heart failure. Heart. 2015 Jul;101(14):1149-58. doi: 10.1136/heartjnl-2015-307558. Epub 2015 May 25. |
| 38299348 | Derived | Ammirati E, Marchetti D, Colombo G, Pellicori P, Gentile P, D'Angelo L, Masciocco G, Verde A, Macera F, Brunelli D, Occhi L, Musca F, Perna E, Bernasconi DP, Moreo A, Camici PG, Metra M, Oliva F, Garascia A. Estimation of Right Atrial Pressure by Ultrasound-Assessed Jugular Vein Distensibility in Patients With Heart Failure. Circ Heart Fail. 2024 Feb;17(2):e010973. doi: 10.1161/CIRCHEARTFAILURE.123.010973. Epub 2024 Feb 1. |
| ID | Term |
|---|---|
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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