Clinical trial NCT05774821: Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term Results
Official title: Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Regurgitation
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients CIEDs bearer and affected by a surgically treatable tricuspid regurgitation

Brief summary: Old trials aimed to evaluate Implantable Cardioverter-Defibrillator (ICD) safety and efficacy demonstrated a meaningful decreased rates of sudden death but an increased rate of hospitalization for heart failure . At the time, the chance that an endocardial lead could cause a significant tricuspid regurgitation (TR), leading to worsening heart failure, was not widely considered. Whereas, it is now well established that in patients with cardiac implantable electronic device (CIEDs), moderate or severe TR occurs frequently and it is associated with increased mortality and hospitalization for heart failure.

The present study aims to report the long-term results of tricuspid valve repair and replacement surgery in patients with CIEDs Indeed, patients with TR and CIEDs can be divided in 2 categories: CIEDs induced TR and CIEDs associated TR. In patients with CIEDs induced TR, the valve dysfunction is directly caused by the lead with several mechanism such as mechanical interference with tricuspid valve (TV) leaflet mobility and coaptation (impingement), valve damage during lead placement or manipulation and sub-valvular entanglement. In patients with CIEDs associated TR the valve dysfunction is not directly caused by the lead.

In 2009 approximately 720 000 CIEDs were implanted worldwide \[7\] and since then a continuous increase of CIEDs implantation was registered, with an estimation of 1.4 millions of CIEDs implantation in 2023. With this impressive number of CIEDs requirement, the need for surgical or trans-catheter treatment of severe TR CIEDs induced or associated, increased steadily in the past years and it likely will continue to increase in the next years. However, limited data are available regarding the outcome of tricuspid valve surgery in patients with CIEDs, particularly for the long-term results. With this study we aim to report the long-term result of tricuspid valve repair and replacement in patients with CIEDs.


Eligibility criteria: Inclusion Criteria:

* Adult patients;
* Patients with significant, surgically treatable tricuspid regurgitation (TR) according to guidelines
* Patients with an implantable electronic heart device (CIEDs)
* Patients undergoing surgery, both repair or replacement, of the tricuspid valve, both isolated or associated with intervention on the valves of the left heart sections.
* Patients operated at the Cardiac Surgery Department of the San Raffaele Hospital from 2000 to 2019.

Exclusion Criteria:

* Patients without a CIED

Primary outcomes:
measure: TR recurrency
timeFrame: Through study completion, an average of 7 years
Secondary outcomes:
measure: All causes mortality
timeFrame: Through study completion, an average of 7 years
measure: cardiac mortality
timeFrame: Through study completion, an average of 7 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: