Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging

NCT ID: NCT05721417

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 172 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-02-12

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.

Conditions

Tricuspid Regurgitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Tricuspid valve surgery

Surgical treatment of tricuspid regurgitation, that may be performed by repair or replacement

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michele De Bonis

OTHER

Sponsor Role: lead

Responsible Party

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

IRCCS Ospedale San Raffaele

Milan, , Italy

Countries

Italy

Other Identifiers

LOITAPF

Identifier Type: -

Identifier Source: org_study_id