Clinical trial NCT05721417: Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging
Official title: Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Regurgitation
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by severe TR, degenerative or functional, requiring isolated (not concomitant with other valvular procedures) repair or replacement of the tricuspid valve

Brief summary: Tricuspid regurgitation (TR) was identified as an independent prognostic factor associated with excess mortality and morbidity, independent of left ventricular (LV) function and pulmonary hypertension. Isolated tricuspid surgery has been performed for a long time in a few selected cases, however in recent years several studies have underlined how the poor outcomes described for isolated tricuspid valve surgery seem to be related to the baseline characteristics of the patients and to late referral for surgical treatment rather than the intervention itself. To facilitate patient screening, a new clinical and functional TR staging system has recently been proposed. This classification, which evaluates the progression of morphological variations of the tricuspid valve and right ventricle (RV) in association with the onset of symptoms, identifies several parameters and factors that can be useful for a better stratification of surgical risk. Rather than simply assessing the degree of TR, this new staging mechanism also focuses on symptoms, RV remodeling and function, medical therapy, and right heart failure hospitalizations.

Investigators previously focused on the short-term (mainly hospital) outcomes of patients undergoing isolated surgery for severe TR, who were classified at baseline according to this clinical and functional staging system. Results showed that a more comprehensive classification reflects the population and hospital outcomes of surgically treated patients with isolated TR.

The purpose of this study is to ultimately evaluate long-term outcomes of this patients population and estimate the impact of baseline staging on long-term outcomes.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Affected by severe tricuspid regurgitation (TR), both of degenerative and functional etiology and;
* Patients underwent isolated surgery, either repair or replacement, of the tricuspid valve
* Patients operated on at theCardiac Surgery Department of San Raffaele Hospital from May 2004 to May 2020.

Exclusion Criteria:

- Patients with non-isolated tricuspid valve surgery (concomitant surgery on other valves).

Primary outcomes:
measure: Mortality
timeFrame: Up to 17 years
measure: Reoperation for TR recurrency
timeFrame: Up to 17 years
measure: Right heart failure hospitalization incidence
timeFrame: Up to 17 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: