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This single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive echocardiographic assessment, including advanced three-dimensional (3D) transthoracic and transesophageal imaging.
The primary objective of this study is to assess the prevalence and leading mechanism of new or worsening TR, defined as an increase of at least one grade on a five-grade scale, after new CIED implantation.
Secondary objectives include clinical and echocardiographic endpoints at discharge, three months, one year, and annually for up to five years.
They can be summarized as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIED | Patients undergoing new implantation of a CIED Inclusion criteria
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change in TR at least one grade after new CIED implantation | TR severity grade assessed using echocardiographic multi-parametric approach, including 3D echocardiography if possible. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of mortality (all-cause, cardiovascular, non-cardiovascular) | 5 years | |
| Incidence of heart failure Hospitalization or any change in diuretic dosage or need for intravenous diuretics | 1 year, and annually through 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing new implantation of a CIED
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi P Badano, MD, Ph.D. | Contact | +3902619112319 | l.badano@auxologico.it | |
| Michele Tomaselli, MD, Ph.D. | Contact | 02619112648 | m.tomaselli5@campus.unimib.it |
| Name | Affiliation | Role |
|---|---|---|
| Luigi Badano, MD, Ph.D. | Istituto Auxologico Italiano, IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Luca Hospital | Recruiting | Milan | MI | 20149 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32589674 | Background | Seo J, Kim DY, Cho I, Hong GR, Ha JW, Shim CY. Prevalence, predictors, and prognosis of tricuspid regurgitation following permanent pacemaker implantation. PLoS One. 2020 Jun 26;15(6):e0235230. doi: 10.1371/journal.pone.0235230. eCollection 2020. | |
| 33132050 | Background | Kanawati J, Ng ACC, Khan H, Yu C, Hyun K, Abed H, Kritharides L, Sy RW. Long-Term Follow-Up of Mortality and Heart Failure Hospitalisation in Patients With Intracardiac Device-Related Tricuspid Regurgitation. Heart Lung Circ. 2021 May;30(5):692-697. doi: 10.1016/j.hlc.2020.08.028. Epub 2020 Oct 31. |
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Depends on subscription of a Data transfer agreement
5 years
Researchers who are members of Institutions who will subscribe a data transfer agreement for this specific study
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| New York Heart Association (NYHA) functional class | at 1 day, 3 months, 1 year, and annually through 5 years |
| Incidence of tricuspid valve intervention (either transcatheter or surgical) | 1 year, and annually through 5 years |
| 32470533 | Background | Papageorgiou N, Falconer D, Wyeth N, Lloyd G, Pellerin D, Speechly-Dick E, Segal OR, Lowe M, Rowland E, Lambiase PD, Chow AW, Bhattacharyya S. Effect of tricuspid regurgitation and right ventricular dysfunction on long-term mortality in patients undergoing cardiac devices implantation: >10-year follow-up study. Int J Cardiol. 2020 Nov 15;319:52-56. doi: 10.1016/j.ijcard.2020.05.062. Epub 2020 May 27. |
| 26833208 | Background | Delling FN, Hassan ZK, Piatkowski G, Tsao CW, Rajabali A, Markson LJ, Zimetbaum PJ, Manning WJ, Chang JD, Mukamal KJ. Tricuspid Regurgitation and Mortality in Patients With Transvenous Permanent Pacemaker Leads. Am J Cardiol. 2016 Mar 15;117(6):988-92. doi: 10.1016/j.amjcard.2015.12.038. Epub 2016 Jan 6. |
| 25377489 | Background | Al-Bawardy R, Krishnaswamy A, Rajeswaran J, Bhargava M, Wazni O, Wilkoff B, Tuzcu EM, Martin D, Thomas J, Blackstone E, Kapadia S. Tricuspid regurgitation and implantable devices. Pacing Clin Electrophysiol. 2015 Feb;38(2):259-66. doi: 10.1111/pace.12530. Epub 2014 Nov 7. |
| 24449717 | Background | Hoke U, Auger D, Thijssen J, Wolterbeek R, van der Velde ET, Holman ER, Schalij MJ, Bax JJ, Delgado V, Marsan NA. Significant lead-induced tricuspid regurgitation is associated with poor prognosis at long-term follow-up. Heart. 2014 Jun;100(12):960-8. doi: 10.1136/heartjnl-2013-304673. Epub 2014 Jan 21. |
| 24022757 | Background | Baquero GA, Yadav P, Skibba JB, Banchs JE, Linton-Frazier LN, Lengerich EJ, Samii SM, Penny-Peterson E, Wolbrette DL, Luck JC, Naccarelli GV, Gonzalez MD. Clinical significance of increased tricuspid valve incompetence following implantation of ventricular leads. J Interv Card Electrophysiol. 2013 Dec;38(3):197-202. doi: 10.1007/s10840-013-9826-2. |